Efficacy and Safety Study of Ontamalimab as Maintenance Treatment in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 307)

A Phase 3 Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Study of SHP647 as Maintenance Therapy in Subjects With Moderate to Severe Crohn's Disease (CARMEN CD 307)

Patrocinadores

Patrocinador principal: Shire

Fuente Shire
Resumen breve

The purpose of this study is to evaluate the efficacy and safety of ontamalimab as maintenance treatment in participants with moderate to severe Crohn's disease (CD).

Estado general Recruiting
Fecha de inicio February 6, 2019
Fecha de Terminación August 26, 2022
Fecha de finalización primaria August 26, 2022
Fase Phase 3
Tipo de estudio Interventional
Resultado primario
Medida Periodo de tiempo
Number of Participants With Clinical Remission at Week 52 Week 52
Number of Participants With Enhanced Endoscopic Response at Week 52 Week 52
Resultado secundario
Medida Periodo de tiempo
Number of Participants With Clinical Remission as Measured by Crohn's Disease Activity Index (CDAI) Less Than (<) 150 at Week 52 Week 52
Number of Participants With Glucocorticoid-free Clinical Remission at Week 52 Week 52
Number of Participants With Clinical Remission as Defined by Crohn's Disease (CD) e-diary Subscores at Week 52 Week 52
Number of Participants With Sustained Clinical Remission at Week 52 Baseline up to Week 52
Number of Participants With Sustained Enhanced Endoscopic Response at Week 52 Baseline up to Week 52
Number of Participants With Clinical Remission and Enhanced Endoscopic Response at Week 52 Week 52
Number of Participants With Complete Endoscopic Healing at Week 52 Week 52
Number of Participants With Clinical Response Over Time Based on 2-item PRO Baseline up to Week 52
Number of Participants With Clinical Remission Over Time as Measured by 2-item PRO Baseline up to Week 52
Number of Participants With Clinical Remission Over Time as Measured by Crohn's Disease Activity Index (CDAI) <150) Baseline up to Week 52
Number of Participants With Sustained Clinical Remission Over Time as Measured by 2-item PRO Baseline up to Week 52
Number of Participants With Sustained Clinical remission Over Time as Measured by Crohn's Disease Activity Index (CDAI) Less than (<) 150 Baseline up to Week 52
Change From Baseline in Individual and Total Sign/Symptom Score Based on Participant Daily e-Diary Entries at Week 52 Baseline, Week 52
Number of Participants With Clinical Response as Measured by At least 100-point Reduction in Crohn's Disease Activity Index (CDAI-100 response) Score Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants With Clinical Response as Measured by At least 70-point Reduction in Crohn's Disease Activity Index (CDAI-70 response) Score Baseline, Weeks 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48 and 52
Number of Participants With Endoscopic Healing at Week 52 Week 52
Number of Participants With Sustained Endoscopic Healing at Week 52 Baseline up to Week 52
Number of Participants With Sustained Complete Endoscopic Healing at Week 52 Baseline up to Week 52
Change From Induction Study Baseline in Histology Scores at Week 52 as Assessed by Colonic Global Histologic Disease Score (CGHAS) Baseline, Week 52
Change From Induction Study Baseline in Histology Scores at Week 52 as Assessed by Ileal Global Histologic Disease Score (IGHAS) Baseline, Week 52
Change From Induction Study Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) Total (Absolute) Scores Baseline, Week 12, Week 24 and Week 52, or early termination
Change From Induction Study Baseline in Short Form-36 Health Survey (SF-36) at Week 52 Baseline, Week 52
Incidence of Hospitalizations Baseline up to Week 68
Incidence of Total Inpatient Days Baseline up to Week 68
Incidence of Crohn's Disease (CD)-related and Other Surgeries Baseline up to Week 68
Inscripción 983
Condición
Intervención

Tipo de intervención: Drug

Nombre de intervención: Ontamalimab

Descripción: SC injection of 25 mg or 75 mg ontamalimab will be administered using a prefilled syringe.

Tipo de intervención: Other

Nombre de intervención: Placebo

Descripción: SC injection of placebo matched with ontamalimab will be administered using a prefilled syringe.

Etiqueta de grupo de brazo: Placebo

Elegibilidad

Criterios:

Inclusion Criteria:

- Participants and/or their parent or legally authorized representative (LAR) must have an understanding, ability, and willingness to fully comply with study procedures and restrictions.

- Participants must be able to voluntarily provide written, signed, and dated (personally or via a LAR) informed consent and/or assent, as applicable, to participate in the study.

- Participants must have completed the 16-week induction treatment period from study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and met the following criteria at baseline in maintenance study SHP647-307:

a) Meet endoscopic response criteria of a reduction in SES-CD from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline by greater than or equal to >=25% at Week 16 of induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) or b) Meet at least 1 of the following 4 criteria at baseline in maintenance study SHP647-307, in addition to no worsening of endoscopic score as measured by SES-CD relative to induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline: i) Achieving clinical remission as determined by meeting the criteria for clinical remission using the 2-item PRO, that is, 2-item PRO subscores of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days* and average daily stool type frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*.

ii) A decrease of at least 100 points in CDAI score (CDAI-100) from induction studies baseline.

iii) A decrease of >=30% and at least 2 points from induction studies baseline in the average daily worst abdominal pain over the 7 most recent days*, with the average daily stool frequency of type 6/7 (very soft stools/liquid stools) either: (i) not worsening from induction studies baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO subscore of average daily stool frequency <=2 of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*.

iv) A decrease of >=30% from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline in the average daily stool frequency of type 6/7 (very soft stools/liquid stools) as shown in the BSFS over the 7 most recent days*, with the average daily worst abdominal pain either: (i) not worsening from induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) baseline and/or (ii) meeting the criteria for clinical remission, that is, 2-item PRO subscore of average worst daily abdominal pain <=3 (based on 11-point NRS) over the 7 most recent days*.

*Note: The 7 days may or may not be contiguous during the 10 days of data collection before colonoscopy preparation, depending on days to be excluded because of missing data. If fewer than 7 days are available, the criterion will be calculated on all available most recent 6 or 5 days. If fewer than 5 days are available, the criterion will be treated as missing.

- Participants receiving any treatments for CD are eligible provided they have been, and are anticipated to be, on a stable dose for the designated period of time.

Exclusion Criteria:

- Participants who had major protocol deviations (as determined by the sponsor) in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).

- Participants who permanently discontinued investigational product because of an AE, regardless of relatedness to investigational product, in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).

- Participants who are likely to require surgery for CD during the study period, except minor interventions (eg, seton placement for anal fistulas).

- Participants are females who became pregnant during induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823), females who are lactating, females who are planning to become pregnant during the study period, or males or females of childbearing potential not agreeing to continue acceptable contraception methods (ie, highly effective methods for female participants and medically appropriate methods for male participants) through the conclusion of study participation.

- Participants who do not agree to postpone donation of any organ or tissue, including male participants who are planning to bank or donate sperm and female participants who are planning to harvest or donate eggs, for the duration of the study and through 16 weeks after last dose of investigational product.

- Participants who, in the opinion of the investigator or the sponsor, will be uncooperative or unable to comply with study procedures.

- Participants who have developed obstructive colonic stricture, or enterovesical or enterovaginal fistulae during the induction study SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823).

- Participants who have a newly diagnosed malignancy or recurrence of malignancy (other than resected cutaneous basal cell carcinoma, squamous cell carcinoma, or carcinoma in situ of the uterine cervix that has been treated with no evidence of recurrence).

- Participants who have developed any major illness/condition or evidence of an unstable clinical condition (example [eg,] renal, hepatic, hematologic, gastrointestinal (except disease under study), endocrine, cardiovascular, pulmonary, immunologic [eg, Felty's syndrome], or local active infection/infectious illness) that, in the investigator's judgment, will substantially increase the risk to the participant if he or she participates in the study.

- Participants with any other severe acute or chronic medical or psychiatric condition or laboratory or ECG abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study.

- Participants with known exposure to Mycobacterium tuberculosis (TB) since testing at screening in induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823) and who have been advised to require treatment for latent or active disease but who are without a generally accepted course of treatment.

- Participants with any of the following abnormalities in hematology and/or serum chemistry profiles during the evaluation of the last visit in the induction studies SHP647-305 (NCT03559517) or SHP647-306 (NCT03566823). If the results are considered by the investigator to be transient and inconsistent with the participant's clinical condition, may be repeated once prior to enrolment in Study SHP647-307.

1. Alanine aminotransferase (ALT) and aspartate aminotransferase levels >= 3.0 × the upper limit of normal (ULN).

2. Total bilirubin level >=1.5 × ULN or >2.0 × ULN if the participant has a known documented history of Gilbert's syndrome.

3. Hemoglobin level <=80 gram per liter (g/L) (8.0 gram per deciliter [g/dL]).

4. Platelet count <=100 × 10^9/L (100,000 cells per cubic millimeter [mm^3]) or >=1000 × 10^9/L (1,000,000 cells/mm^3).

5. White blood cell count <=3.5 × 10^9/L (3500 cells/mm^3).

6. Absolute neutrophil count<2 × 10^9/L (<2000 cells/mm^3)

7. Serum creatinine level >1.5 × ULN or estimated glomerular filtration rate <30 milliliter per minute (mL/min)/1.73 m^2 based on the abbreviated Modification of Diet in Renal Disease Study Equation.

- Note: If platelet count is <150,000 cells/mm^3, a further evaluation should be performed to rule out cirrhosis, unless another etiology has already been identified.

- Participants who are investigational site staff members or relatives of those site staff members or participants who are sponsor employees directly involved in the conduct of the study.

- Participants who are participating in other investigational studies (other than induction studies SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]) or plan to participate in other investigational studies during this study.

Género: All

Edad mínima: 16 Years

Edad máxima: 80 Years

Voluntarios Saludables: No

Oficial general
Apellido Papel Afiliación
Study Director Study Director Shire
Contacto general

Apellido: Shire Contact

Teléfono: +1 866 842 5335

Email: [email protected]

Ubicación
Instalaciones: Estado: Contacto: Investigador:
Arizona Digestive Health Mesa - East | Mesa, Arizona, 85206, United States Recruiting Site Contact 480-889-1211 [email protected] Doo-Sang Cho, MD Principal Investigator
Elite Clinical Studies - Phoenix - BTC - PPDS | Phoenix, Arizona, 85018, United States Recruiting Site Contact 602-788-3437 [email protected] Joseph Lillo, DO Principal Investigator
CATS Research Center - University of Arizona | Tucson, Arizona, 85724, United States Recruiting Site Contact 520-626-6453 [email protected] Sasha Taleban, MD Principal Investigator
Atria Clinical Research - BTC - PPDS | Little Rock, Arkansas, 72209, United States Recruiting Site Contact 501-492-9175 [email protected] Meenakshi Budhraja, MD Principal Investigator
Advanced Research Center | Anaheim, California, 92805, United States Recruiting Site Contact 714-493-7258 [email protected] Austina Cho Principal Investigator
Kindred Medical Institute for Clinical Trials, LLC | Corona, California, 92879, United States Recruiting Site contact 951-220-4029 [email protected] M. Mazen Jamal, MD Principal Investigator
OM Research LLC - Lancaster - ClinEdge - PPDS | Lancaster, California, 93534, United States Recruiting Site contact 310-684-2494 [email protected] Jatinder Pruthi, MD Principal Investigator
Alliance Clinical Research-(Vestavia Hills) | Poway, California, 92064, United States Recruiting Site Contact 949-973-3704 [email protected] Kevin Merkes, MD Principal Investigator
Inland Empire Liver Foundation | Rialto, California, 92377, United States Recruiting Site Contact 909-883-2999 [email protected] Zeid Kayali, MBA, MD Principal Investigator
Care Access Research, San Pablo | San Pablo, California, 94806, United States Recruiting Site contact 415-408-8734 [email protected] Mark Kogan, MD Principal Investigator
Peak Gastroenterology Associates | Colorado Springs, Colorado, 80903, United States Recruiting Site contact 719-636-1201 [email protected] Bhaktasharan Patel, MD Principal Investigator
Asthma and Allergy Associates PC - CRN | Colorado Springs, Colorado, 80907, United States Recruiting Site Contact 719-473-0872 [email protected] Daniel Soteres, MD Principal Investigator
Renaissance Research Medical Group, INC | Cape Coral, Florida, 33991, United States Recruiting Site Contact 239-800-4893 [email protected] Alfonso Garcia Bello, MD Principal Investigator
Gastro Florida | Clearwater, Florida, 33756, United States Recruiting Site Contact 727-347-0536 [email protected] Lawrence Weiss, MD Principal Investigator
Advanced Clinical Research Network | Coral Gables, Florida, 33134, United States Recruiting Site contact 305-702-1594 [email protected] Gil Fernandez-Yera, MD Principal Investigator
Alliance Medical Research LLC | Coral Springs, Florida, 33071, United States Recruiting Site contact 954-428-2480 [email protected] Vipin Gupta, MB, MD Principal Investigator
SIH Research | Kissimmee, Florida, 34741, United States Recruiting Site Contact 407-932-1977 [email protected] Syed Mumtaz, MBBS, MD Principal Investigator
Crystal Biomedical Research | Miami Lakes, Florida, 33065, United States Recruiting Site Contact 305-828-7900 [email protected] Angel Rico, MD Principal Investigator
Hi Tech and Global Research, LLc | Miami, Florida, 33135, United States Recruiting Site Contact 305-642-7212 [email protected] Jorge Beato, MD Principal Investigator
Sanchez Clinical Research, Inc | Miami, Florida, 33157, United States Recruiting Site Contact 305-234-9484 [email protected] Mirel Sanchez, MD Principal Investigator
Gastroenterology Group of Naples | Naples, Florida, 34102, United States Recruiting Site Contact 239-649-1186 [email protected] Raymond Phillips, MD Principal Investigator
Pharma Research International Inc | Naples, Florida, 34110, United States Recruiting Site Contact 239-593-6201 [email protected] Steven Meckstroth, MD Principal Investigator
Omega Research Consultants LLC - BTC - PPDS | Orlando, Florida, 32810, United States Recruiting Site Contact 407-271-8030 [email protected] Kwabena Ayesu, MD Principal Investigator
Meridien Research - St. Petersburg - PPDS | Pinellas Park, Florida, 33781, United States Recruiting Site Contact 727-347-8839 [email protected] Venkata Iyunni, MD Principal Investigator
East Coast Institute for Research, LLC | Saint Augustine, Florida, 32086, United States Recruiting Site Contact 904-824-1776 [email protected] Anis Ahmadi, MD Principal Investigator
DBC Research | Tamarac, Florida, 33321, United States Recruiting Site Contact 954-537-2100 [email protected] Kevin Bender, MD Principal Investigator
Bayside Clinical Research | Tampa, Florida, 33604, United States Recruiting Site Contact 813-810-2119 [email protected] Tatiana Hernandez, MD Principal Investigator
Atlanta Gastroenterology Specialists, PC | Atlanta, Georgia, 30308, United States Recruiting Site contact 678-957-0057 [email protected] Bruce Salzberg, MD Principal Investigator
Infinite Clinical Trials | Atlanta, Georgia, 30349, United States Recruiting Site Contact 678-430-3232 [email protected] Eva Beaulieu, MD Principal Investigator
Atlanta Center For Gastroenterology PC | Decatur, Georgia, 30033, United States Recruiting Site Contact 404-296-1986 [email protected] David Rausher, MD Principal Investigator
Loretto Hospital | Chicago, Illinois, 60644, United States Recruiting Site Contact 630-491-1901 [email protected], [email protected] Ilysa Diamond, DO Principal Investigator Bhupatkumar Mehta, MD Principal Investigator
IL Gastroenterology Group | Gurnee, Illinois, 60031, United States Recruiting Site Contact 847-604-8700 [email protected] Fred Rosenberg, MD Principal Investigator
Laporte County Institute For Clinical Research | Michigan City, Indiana, 46360, United States Recruiting Site contact 219-879-0333 [email protected] Minesh Patel, MD Principal Investigator
Cotton O'Neil Clinical Research Center | Topeka, Kansas, 66606, United States Recruiting Site Contact 785-270-4856 [email protected] Curtis Baum, MD Principal Investigator
Gastroenterology Associates of Hazard | Hazard, Kentucky, 41701, United States Recruiting Site Contact 606-439-3952 [email protected] Uday Shankar, MD Principal Investigator
CroNOLA, LLC. | Houma, Louisiana, 70360, United States Recruiting Site Contact 985-601-2662 [email protected] Nathaniel Winstead, MD Principal Investigator
Clinical Trials of SWLA LLC | Lake Charles, Louisiana, 70601, United States Recruiting Site contact 337-493-5310 [email protected] Ricardo McCall, MD Principal Investigator
DelRicht Clinical Research, LLC - ClinEdge - PPDS | New Orleans, Louisiana, 70115, United States Recruiting Site Contact 504-336-2667 [email protected] Patrick Dennis, MD Principal Investigator
Louisiana Research Center LLC | Shreveport, Louisiana, 71103, United States Recruiting Site Contact 318-525-3233 [email protected] Humberto Aguilar, MD Principal Investigator
Commonwealth Clinical Studies LLC | Brockton, Massachusetts, 02302, United States Recruiting Site Contact 508-588-9900 [email protected] Jerry Stern, MD Principal Investigator
Winchester Gastroenterology Associates | Winchester, Massachusetts, 22601, United States Recruiting Site Contact 540-667-1244 [email protected] Nicholas Snow, MD Principal Investigator
UMass Memorial Medical Center | Worcester, Massachusetts, 01655, United States Recruiting Site contact 774-442-4098 [email protected] Jean Marie Houghton, MD Principal Investigator
University of Michigan | Ann Arbor, Michigan, 48109, United States Recruiting Site Contact 734-764-0507 [email protected] Peter Higgins, MD, MSc, PhD Principal Investigator
Clinical Research Institute of Michigan | Chesterfield, Michigan, 48047, United States Recruiting Site contact 586-598-3329 [email protected] Ronald Fogel, MD Principal Investigator
National Clinical, LLC | Hamtramck, Michigan, 48212, United States Recruiting Site Contact 313-891-1500 [email protected] Harshavardhan Krishna Principal Investigator
Gastroenterology Associates of Western Michigan, PLC | Wyoming, Michigan, 49519, United States Recruiting Site Contact 616-608-8730 [email protected] Allan Coates, DO Principal Investigator
Mayo Clinic Health System - PPDS | Duluth, Minnesota, 55805, United States Recruiting Site Contact 608-782-9760 [email protected] Michael Van Norstrand, MD Principal Investigator
Minnesota Gastroenterology PA | Saint Paul, Minnesota, 55114, United States Recruiting Site Contact 612-870-5595 [email protected] Robert McCabe, Jr. Principal Investigator
Washington University in St. Louis | Saint Louis, Missouri, 63110, United States Recruiting Site Contact 314-273-1947 [email protected] George Christophi, MD Principal Investigator Matthew Ciorba, MD Principal Investigator
Advanced Biomedical Research of America | Las Vegas, Nevada, 89123, United States Recruiting Site contact 702-898-2088 [email protected] Vrijendra Hoon, MD Principal Investigator
Encompass Care | North Las Vegas, Nevada, 89086, United States Recruiting Site Contact 702-677-2273 [email protected] Curtis Bazemore, MD Principal Investigator
New York Total Medical Care PC | Brooklyn, New York, 11215, United States Recruiting Site Contact 718-499-6099 [email protected] Jorge Serje, MD Principal Investigator
NYU Langone Long Island Clinical Research Associates | Great Neck, New York, 11021, United States Recruiting Site Contact 516-466-2340 [email protected] Seymour Katz, MD Principal Investigator
Southtowns Gastroenterology, PLLC | Orchard Park, New York, 14127, United States Recruiting Site Contact 716-249-6700 [email protected] Albert Diaz-Ordaz, MD Principal Investigator
Piedmont Healthcare | Statesville, North Carolina, 28625, United States Recruiting Site Contact 704-873-4277 [email protected] Vivek Trivedi, MD Principal Investigator
Consultants For Clinical Research Inc | Cincinnati, Ohio, 45219, United States Recruiting Site contact 513-872-4549 [email protected] Pradeep Bekal, MD Principal Investigator
Consultants For Clinical Research Inc | Cincinnati, Ohio, 45249, United States Recruiting Site contact 513-751-6667 [email protected] Christopher South, MD Principal Investigator
Consultants For Clinical Research Inc | Fairfield, Ohio, 45014, United States Recruiting Site contact 513-860-4801 [email protected] Jeffrey Stotz, MD Principal Investigator
Penn State Hershey Medical Group | State College, Pennsylvania, 16803, United States Recruiting Site Contact 814-272-4445 [email protected] Joel Haight, MD Principal Investigator
Digestive Disease Associates | Wyomissing, Pennsylvania, 19610, United States Recruiting Site Contact 610-374-4401 206 [email protected] Nirav Shah, MD Principal Investigator
Gastro One | Germantown, Tennessee, 38138, United States Recruiting Site contact 901-820-0090 [email protected] Ziad Younes, MD Principal Investigator
Vanderbilt University Medical Center | Nashville, Tennessee, 37212, United States Recruiting Site Contact 615-322-4643 [email protected] Dawn Beaulieu, MD Principal Investigator
Advanced Gastroenterology-Union City | Union City, Tennessee, 38261, United States Recruiting Site contact 731-884-0600 [email protected] Kofi Nuako, MD Principal Investigator
Northside Gastroenterology | Cypress, Texas, 77429, United States Recruiting Site contact 281-477-9305 [email protected] Ayub Hussain, MD Principal Investigator
Digestive Health Associates of Texas, P.A.dba DHAT Research Institute | Garland, Texas, 75044, United States Recruiting Site Contact 972-487-8855 [email protected] Jr. Harry Sarles, MD Principal Investigator
Precision Research Institute, LLC | Houston, Texas, 77039, United States Recruiting Site contact 713-777-2555 [email protected] Alan Glombicki, MD Principal Investigator
Biopharma Informatic Inc. | Houston, Texas, 77043, United States Recruiting Site contact 281-768-5879 [email protected] Mouhamad Al-Sabbagh, MD Principal Investigator
Southwest Clinical Trials | Houston, Texas, 77074, United States Recruiting Site Contact 281-216-3658 [email protected] Dilawar Ajani, MD Principal Investigator
BI Research Center | Houston, Texas, 77084, United States Recruiting Site contact 281-945-4368 [email protected] Jr.James Maher, MD Principal Investigator
Southern Star Research Institute LLC | San Antonio, Texas, 78229, United States Recruiting Site contact 210-558-2794 2218 [email protected] Jeff Bullock, MD Principal Investigator
Inquest Clinical Research/Coastal Gastroenterology Associates, PA | Webster, Texas, 77598, United States Recruiting Site contact 281-557-2527 [email protected] Advitya Malhotra, MD Principal Investigator
HP Clinical Research | Bountiful, Utah, 84010, United States Recruiting Site Contact 801-797-9315 [email protected] Val Hansen, MD Principal Investigator
Mid Atlantic Health Specialists | Galax, Virginia, 24333, United States Recruiting Site Contact 276-236-2947 [email protected] Robert Benish, MD Principal Investigator
Fundación Favaloro | Buenos Aires, C1093AAS, Argentina Recruiting Site contact +541143781200 [email protected] Claudia Fuxman, MD Principal Investigator
Hospital Privado Centro Médico de Córdoba | Córdoba, Argentina Recruiting Site Contact +03514688200 [email protected] Domingo Balderramo, MD Principal Investigator
Concord Repatriation General Hospital | Concord, New South Wales, 2139, Australia Recruiting Site Contact +61297676111 [email protected] Rupert Leong, MBBS, MD Principal Investigator
Liverpool Hospital | Liverpool, New South Wales, 2170, Australia Recruiting Site Contact +61287384085 [email protected] Susan Connor, MBBS Principal Investigator
Mater Hospital Brisbane | South Brisbane, Queensland, 4101, Australia Recruiting Site contact +61731638518 [email protected] Jakob Begun, MD Principal Investigator
Royal Adelaide Hospital | Bedford Park, South Australia, 5042, Australia Recruiting Site Contact +610882044964 [email protected] Peter Bampton, BS, MB, MD, PhD Principal Investigator
The Alfred Hospital | Melbourne, Victoria, 3004, Australia Recruiting Site contact +61398950369 [email protected] Miles Sparrow, MBBS, MD Principal Investigator
St Vincents Hospital Melbourne - PPDS | Melbourne, Victoria, 3065, Australia Recruiting Site contact +61392312211 [email protected] Nik Ding, MD Principal Investigator
LKH-Universitätsklinikum Klinikum Graz | Graz, Steiermark, 8036, Austria Recruiting Site Contact +43031638514388 [email protected] Christoph Högenauer Principal Investigator
Klinikum Wels-Grieskirchen GmbH | Vienna, Wien, A-1090, Austria Recruiting Site Contact +43072424152181 [email protected] Harald Hofer Principal Investigator
Salzburger Landeskliniken | Salzburg, 5020, Austria Recruiting Site Contact +435725557296 [email protected] Sonja Gassner, MD Principal Investigator
Medizinische Universitat Wien | Wien, 1090, Austria Recruiting Site Contact +43140411 [email protected] Walter Reinisch, MD Principal Investigator
Academisch Medisch Centrum Amsterdam | Bonheiden, Antwerpen, 2820, Belgium Recruiting Site Contact +3215505011 [email protected] Geert D'Haens, MD Principal Investigator
UZ Gent | Gent, Oost-Vlaanderen, 9000, Belgium Recruiting Site Contact +3293325166 [email protected] Triana Lobaton, MD Principal Investigator
AZ Groeninge | Kortrijk, West-Vlaanderen, 8500, Belgium Recruiting Site Contact +3256633300 [email protected] Wouter Van Moerkercke, MD Principal Investigator
CHU Mouscron | Mouscron, 7700, Belgium Recruiting Site contact +3256858585 [email protected] Abdo El Nawar Principal Investigator
Clinical Center Banja Luka | Banja Luka, 78000, Bosnia and Herzegovina Recruiting Site Contact +38765547375 [email protected] Aleksandar Dobrovoljski, MD Principal Investigator
Acibadem City Clinic University Multiprofile Hospital for Active Treatment EOOD | Sofia, Sofia-Grad, 1784, Bulgaria Recruiting Site contact +359896889557 [email protected] Asen Petrov, MD Principal Investigator
Multiprofile Hospital for Active Treatment Eurohospital | Plovdiv, 4004, Bulgaria Recruiting Site contact +359888E11 [email protected] Penka Akrabova, MD Principal Investigator
Second Multiprofile Hospital for Active Treatment Sofia | Sofia, 1202, Bulgaria Recruiting Site Contact +359885E11 [email protected] Nikolay Tsonev, MD Principal Investigator
Diagnostic and Consulting Center Aleksandrovska EOOD | Sofia, 1431, Bulgaria Recruiting Site Contact +35929230654 [email protected] Diana Petrova, MD, PhD Principal Investigator
University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD | Sofia, 1431, Bulgaria Recruiting Site contact +35929526319 [email protected] Rosen Nikolov, MD Principal Investigator
University Multiprofile Hospital for Active Treatment Tsaritsa Yoanna - ISUL EAD | Sofia, 1527, Bulgaria Recruiting Site Contact +35929432519 [email protected] Plamen Penchev, MD Principal Investigator
Medical Center Excelsior OOD - PPDS | Sofia, 1632, Bulgaria Recruiting Site Contact +35924036211 [email protected] Mario Markov, MD Principal Investigator
Medical Center Convex EOOD | Sofia, 1680, Bulgaria Recruiting Site Contact +359888932556 [email protected] Ludmila Tankova Principal Investigator
Diagnostic Consultative Centre Mladost - M OOD | Varna, 9000, Bulgaria Recruiting Site Contact +35952302891 [email protected] Iskren Kotzev, MD Principal Investigator
Fundación Valle Del Lili | Cali, Valle Del Cauca, 760026, Colombia Recruiting Site contact +543814216116 [email protected] Carlos Rojas, MD Principal Investigator
IPS Centro Médico Julián Coronel S.A.S. - PPDS | Cali, Colombia Recruiting Site contact +573004957993 [email protected] Henry Idrobo Quintero Principal Investigator
University Hospital Center Zagreb | Zagreb, Grad Zagreb, 10000, Croatia Recruiting Site Contact +38512420100 [email protected] Marko Brinar, PhD Principal Investigator
Opca bolnica Bjelovar | Bjelovar, 43000, Croatia Recruiting Site Contact +38543279171 [email protected] Marinko Lukic Principal Investigator
Clinical Hospital Centre Osijek | Osijek, 31000, Croatia Recruiting Site Contact +38531511511 [email protected] Vladimir Borzan, MD Principal Investigator
General Hospital Virovitica | Virovitica, 33000, Croatia Recruiting Site contact +38533747291 [email protected] Matko Markotic, MD Principal Investigator
OÜ LV Venter | Parnu, 80010, Estonia Recruiting Site contact +37253333769 [email protected] Liina Viidebaum, MD Principal Investigator
West Tallinn Central Hospital | Tallinn, 10617, Estonia Recruiting Site Contact +37255576881 [email protected] Kulliki Suurmaa, MD Principal Investigator
Klinikum rechts der Isar der Technischen Universität München | Munich, Bayern, 81675, Germany Recruiting Site contact +4908941402450 [email protected] Wolfgang Huber Principal Investigator
Universitätsklinikum der RWTH Aachen | Aachen, Nordrhein-Westfalen, 52074, Germany Recruiting Site Contact +00482418089527 [email protected] Tobias Wenzl, MD Principal Investigator
Uniklinik Köln | Köln, Nordrhein-Westfalen, 50937, Germany Recruiting Site Contact +492214787334 [email protected] Jessica Mertens, MD Principal Investigator
Gastro Campus Research GbR | Münster, Nordrhein-Westfalen, 48159, Germany Recruiting Site contact +4925128466 [email protected] Axel Schweitzer Principal Investigator
Universitatsklinikum Schleswig-Holstein | Kiel, Schleswig-Holstein, 24105, Germany Recruiting Site Contact +4943150022202 [email protected] Stefan Schreiber, MD Principal Investigator
Universitatsklinikum Jena | Jena, Thüringen, 07747, Germany Recruiting Site Contact +4936419324582 [email protected] Philip Grunert, MD Principal Investigator
Gastroenterologische Facharztpraxis am Mexikoplatz | Berlin-Zehlendorf, 14163, Germany Completed
Charité - Universitätsmedizin Berlin | Berlin, 13353, Germany Recruiting Site Contact +4930450553836 [email protected] Andreas Fischer, MD Principal Investigator
Sana Klinikum Biberach | Biberach an der Riss, 88400, Germany Recruiting Site Contact +4907351551220 [email protected] Christian Von Tirpitz, MD Principal Investigator
Universitätsklinikum Frankfurt | Frankfurt, 60596, Germany Recruiting Site contact +496963015055 [email protected] Irina Blumenstein, MD Principal Investigator
Ippokrateio General Hospital of Athens | Athens, Attiki, 11527, Greece Recruiting Site Contact +302105234108 [email protected] Spilios Manolakopoulos, MD Principal Investigator
University General Hospital of Heraklion | Heraklion, 71110, Greece Recruiting Site Contact +302810392253 [email protected] Ioannis Koutroubakis, MD Principal Investigator
Iatriko Palaiou Falirou | Paliao Faliro, 17562, Greece Recruiting Site Contact +306944535945 [email protected] Fotini Laoudi, MD Principal Investigator
University General Hospital of Patras | Patras, 26504, Greece Recruiting Site Contact +2613603499 [email protected] Christos Triantos Principal Investigator
Euromedica - PPDS | Thessaloniki, 54645, Greece Recruiting Site Contact +302310895360 [email protected] Alexandros Kofokotsios, MD Principal Investigator
Bekes Megyei Kozponti Korhaz | Bekescsaba, 5600, Hungary Recruiting Site Contact +3666555582 [email protected] Márta Varga, MD Principal Investigator
Magyar Honvédség Egészségügyi Központ | Budapest, 1062, Hungary Recruiting Site Contact +3613020841 1230 [email protected] Laszlo Herszenyi, DSc, MD, MSc Principal Investigator
Pannónia Magánorvosi Centrum Kft | Budapest, 1135, Hungary Recruiting Site Contact +36303116694 [email protected] Róbert Schnabel, MD Principal Investigator
ENDOMEDIX Kft. | Budapest, 1139, Hungary Recruiting Site Contact +36208258999 [email protected] Alajos Takáts, MD, PhD Principal Investigator
Debreceni Egyetem Klinikai Kozpont | Debrecen, 4032, Hungary Recruiting Site Contact +3652255196 [email protected] István Altorjay, DSc, MD, PhD Principal Investigator
Mohacsi Korhaz | Mohacs, 7700, Hungary Recruiting Site Contact +3669511150 [email protected] Csaba Csizmadia Principal Investigator
Tolna Megyei Balassa János Kórház | Szekszard, 7100, Hungary Recruiting Site Contact +3674501531 [email protected] Ágnes Salamon, MD Principal Investigator
Fejer Megyei Szent Gyorgy Egyetemi Oktato Korhaz | Székesfehérvár, 8000, Hungary Recruiting Site Contact +36209774818 [email protected] Roland Fejes, MD Principal Investigator
St Vincent's University Hospital | Dublin, 4, Ireland Recruiting Site Contact +35312214711 [email protected] Glen Doherty, MD Principal Investigator
Shaare Zedek Medical Center | Jerusalem, 91031, Israel Recruiting Site contact +97226666064 [email protected] Eran Goldin, MD Principal Investigator
Hadassah Medical Center - PPDS | Jerusalem, 91120, Israel Recruiting Site Contact +972529242285 [email protected] Lior Katz, MD Principal Investigator
Galilee Medical Center | Nahariya, 22100, Israel Recruiting Site contact +97249107746 [email protected] Nimer Assy, MD Principal Investigator
Baruch Padeh Poriya Medical Center | Tiberias, 15208, Israel Recruiting Site contact +97246652688 [email protected] William Bahig Nseir, MD Principal Investigator
Azienda Ospedaliera Mater Domini Di Catanzaro | Catanzaro, Calabria, 88100, Italy Recruiting Site Contact +3909613647113 [email protected] Francesco Luzza, MD Principal Investigator
Azienda Ospedaliero Universitaria Di Modena Policlinico | Modena, Emilia-Romagna, 41100, Italy Recruiting Site Contact +390594225308 [email protected] Erica Villa, MD Principal Investigator
Fondazione Policlinico Universitario A Gemelli | Roma, Lazio, 00168, Italy Recruiting Site Contact +390630156018 [email protected] Antonio Gasbarrini, MD Principal Investigator
Azienda Ospedaliera Universitaria Careggi | Firenze, Toscana, 50134, Italy Recruiting Site contact +39557946284 [email protected] Francesca Rogai, MD Principal Investigator
Ospedale Sacro Cuore Don Calabria | Negrar, Veneto, 37024, Italy Recruiting Site Contact +390456013949 [email protected] Andrea Geccherle, MD Principal Investigator
A.O.U. Maggiore della Carità | Novara, 28100, Italy Recruiting Site contact +3903213733206235 [email protected] Pietro Occhipinti, MD Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia | Pavia, 27100, Italy Recruiting Site contact +390382501016 [email protected] Antonio Di Sabatino, MD Principal Investigator
La Sapienza-Università di Roma-Policlinico Umberto I | Roma, 00161, Italy Recruiting Site Contact +390649972360 [email protected] Piero Vernia Principal Investigator
Istituto Clinico Humanitas | Rozzano (MI), 20089, Italy Recruiting Site Contact +39282244771 [email protected] Silvio Danese, MD Principal Investigator
Ospedale Casa Sollievo Della Sofferenza IRCCS | San Giovanni Rotondo, 71013, Italy Recruiting Site contact +8888888888 [email protected] Fabrizio Bossa, MD Principal Investigator
Azienda Ospedaliera Città della Salute e della Scienza di Torino | Torino, 10126, Italy Recruiting Site Contact (390) 116-3363 97 [email protected] Giorgio Saracco, MD Principal Investigator
Sapporo Medical University Hospital | Sapporo, Hokkaidô, 060-8543, Japan Recruiting Site contact +8888888888 [email protected] Hiroshi Nakase Principal Investigator
Medical Corporation Aoyama Clinic | Kobe-shi, Hyôgo, 650-0015, Japan Recruiting Site contact +81783666810 [email protected] Nobuo Aoyama, MD Principal Investigator
Hyogo College of Medicine | Nishinomiya-shi, Hyôgo, 663-8501, Japan Recruiting Site Contact +81798456660 [email protected] Kenji Watanabe, MD Principal Investigator
Jikei University Hospital | Minato-ku, Tokyo, 105-8471, Japan Recruiting Site contact +81334331111 [email protected] Masayuki Saruta, MD Principal Investigator
Ome Municipal General Hospital | Ome, Tokyo, 198-0042, Japan Recruiting Site contact +81428223191 [email protected] Osamu Noguchi Principal Investigator
Kunimoto Hospital | Asahikawa, 070-0061, Japan Recruiting Site contact +81166252241 [email protected] Masanori Murakami Principal Investigator
Hidaka Coloproctology Clinic | Kurume-shi, 839-0809, Japan Recruiting Site contact +81942447737 [email protected] Hisamitsu Hidaka Principal Investigator
Aichi Medical University Hospital | Nagakute, 480-1195, Japan Recruiting Site Contact +81561623311 [email protected] Makoto Sasaki, MD, PhD Principal Investigator
Nishinomiya Municipal Central Hospital | Nishinomiya, 663-8014, Japan Recruiting Site Contact (817) 986-4151 5 [email protected] Hiroyuki Ogawa Principal Investigator
Onomichi General Hospital | Onomichi, Japan Recruiting Site contact +81848228111 [email protected] Seiji Onogawa Principal Investigator
Kinshukai Infusion Clinic | Osaka-shi, 530-0011, Japan Recruiting Site contact +810663601107 [email protected] Hiroaki Ito Principal Investigator
Chiinkai Dojima General & Gastroenterology Clinic | Osaka, 530-0003, Japan Recruiting Site Contact (816) 634-3100 0 [email protected] Koji Sawada Principal Investigator
Yodogawa Christian Hospital | Osaka, 533-0024, Japan Recruiting Site contact +81663222250 [email protected] Saori Matsui, MD Principal Investigator
Shiga University of Medical Science Hospital | Otsu-Shi, 520-2192, Japan Recruiting Site contact +81775482111 [email protected] Shigeki Bamba, MD Principal Investigator
Toho University Sakura Medical Center | Sakura, 285-8741, Japan Recruiting Site contact +81434628811 [email protected] Katsuyoshi Matsuoka, MD Principal Investigator
Sapporo Tokushukai Hospital | Sapporo-shi, 065-0033, Japan Recruiting Site Contact +81118901602 [email protected] Toshifumi Ashida, MD Principal Investigator
Sapporo Higashi Tokushukai Hospital | Sapporo, 065-0033, Japan Recruiting Site Contact +81117221110 Atsuo Maemoto Principal Investigator
Dokkyo Medical University Hospital | Shimotsuga-gun, 321-0293, Japan Recruiting Site Contact +81282861111 [email protected] Keiichi Tominaga Principal Investigator
Nihonbashi Egawa Clinic | Tokyo, 103-0028, Japan Recruiting Site contact +81352040311 [email protected] Kazutada Egawa, MD Principal Investigator
Colo-Proctology Center Matsushima Clinic | Yokohama, 220-0045, Japan Recruiting Site contact +81452417311 [email protected] Koichi Nakajima, MD Principal Investigator
Ishida Clinic of IBD and Gastroenterology | Oita-city, Ôita, 870-0823, Japan Recruiting Site Contact +81975295777 [email protected] Tetsuya Ishida Principal Investigator
Yonsei University Wonju Severance Christian Hospital | Wonju, Gang'weondo, 26426, Korea, Republic of Recruiting Hyun Soo Kim Principal Investigator
CHA Bundang Medical Center, CHA University | Seongnam, Gyeonggido, 13496, Korea, Republic of Recruiting Jee Hyun Kim, MD Principal Investigator
The Catholic University of Korea, St. Vincent's Hospital | Suwon, Gyeonggido, 16247, Korea, Republic of Recruiting Kang Moon Lee, MD Principal Investigator
Inje University Haeundae Paik Hospital | Busan, 48108, Korea, Republic of Recruiting Tae-Oh Kim Principal Investigator
Pusan National University Hospital | Busan, 49241, Korea, Republic of Recruiting Geun Am Song, MD, PhD Principal Investigator
Kyungpook National University Hospital | Daegu, 41944, Korea, Republic of Recruiting Sung Kook Kim, MD Principal Investigator
Kyungpook National University Chilgok Hospital | Daegu, 702-210, Korea, Republic of Recruiting Seong Woo Jeon, MD Principal Investigator
Gachon University Gil Medical Center | Incheon, 21565, Korea, Republic of Recruiting Kwang An Kwon, MD, PhD Principal Investigator
Seoul National University Hospital | Seoul, 03080, Korea, Republic of Recruiting Joo Sung Kim, MD Principal Investigator
Kangbuk Samsung Hospital | Seoul, 03181, Korea, Republic of Recruiting Dong Il Park, MD Principal Investigator
Inje University Seoul Paik Hospital | Seoul, 04551, Korea, Republic of Recruiting You Sun Kim, MD Principal Investigator
Al Zahraa University Hospital | Beirut, Lebanon Recruiting Site Contact +9613813169 [email protected] Mahmoud Hallal, MD Principal Investigator
Hammoud Hospital University Medical Center | Saida, Lebanon Recruiting Site contact +9613249324 [email protected] Majed Bahlawan, MD Principal Investigator
Vilnius University Hospital Santaros Klinikos | Vilnius, LT- 08661, Lithuania Recruiting Site Contact +37068825454 [email protected] Edita Kazenaite, MD Principal Investigator
Vilnius City Clinical Hospital | Vilnius, LT-10207, Lithuania Recruiting Site Contact +37068691382 [email protected] Vilius Petretis, MD Principal Investigator
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. | Zapopan, Jalisco, 45030, Mexico Recruiting Site contact +523315220008 [email protected] Roberto Cruz Neri, MD Principal Investigator
Clinica de Higado y Gastroenterologia Integral, S.C. | Cuernavaca, Morelos, 62170, Mexico Recruiting Site Contact +527773136346 [email protected] Guillermo Cabrera Alvarez, MD Principal Investigator
JM Research S.C | Cuernavaca, Morelos, 62290, Mexico Recruiting Site Contact +527772633200 [email protected] Jose-León López-Bucio, MD Principal Investigator
Unidad de Atencion Medica e Investigacion en Salud | Merida, Yucatán, 97000, Mexico Recruiting Site contact +529992110094 [email protected] Lourdes Lol-Be Pinzon Te, MD Principal Investigator
Centro de Investigacion Clinica Acelerada, S.C. | Distrito Federal, 07020, Mexico Recruiting Site Contact +525557813954 [email protected] Jose Gilberto Romero Lozano Principal Investigator
Instituto de Investigaciones Aplicadas a la Neurociencia A.C. | Durango, 34000, Mexico Recruiting Site Contact +526181973882 [email protected] Raquel Girondelle Morones Esquivel, MD Principal Investigator
Accelerium, S. de R.L. de C.V. | Monterrey, 64000, Mexico Recruiting Site contact +528155158006 [email protected] Genaro Vázquez Elizondo, MD Principal Investigator
ETZ-Elisabeth | Tilburg, Noord-Brabant, 5022 GC, Netherlands Recruiting Site Contact +0031135395599 [email protected] Maurice Lutgens, MD Principal Investigator
NWZ, location Alkmaar | Den Helder, Noord-Holland, 1782 GZ, Netherlands Recruiting Site Contact +31223696394 [email protected] Peter Viergever, PhD Principal Investigator
Dunedin Hospital | Dunedin, South Island, 9016, New Zealand Recruiting Site contact +6434740999 [email protected] Michael Schultz, MD, PhD Principal Investigator
Wellington Hospital | Newtown, Wellington, 6021, New Zealand Recruiting Site Contact +6449185117 [email protected] Benjamin Griffiths, MD Principal Investigator
Waikato Hospital | Hamilton, 3240, New Zealand Recruiting Site Contact +6478398899 [email protected] James Brooker, BSc, MBBS Principal Investigator
Melita Medical | Wroclaw, Dolnoslaskie, 50-449, Poland Recruiting Site contact +48661302302 [email protected] Jaroslaw Leszczyszyn, MD, PhD Principal Investigator
Lexmedica | Wroclaw, Dolnoslaskie, 53-114, Poland Recruiting Site Contact +48717660290 [email protected] Jerzy Rozciecha, MD, PhD Principal Investigator
Vitamed Galaj i Cichomski sp.j. | Bydgoszcz, Kujawsko-pomorskie, 85-079, Poland Recruiting Site Contact +48665102401 [email protected] Piotr Sikorski, MD Principal Investigator
Gastromed Kopon Zmudzinski i Wspolnicy Sp.j.Specjalistyczne Centrum Gastrologii i Endoskopii Specj | Torun, Kujawsko-pomorskie, 87-100, Poland Recruiting Site Contact +48694958366 [email protected] Marcin Zmudzinski, MD, PhD Principal Investigator
Centrum Diagnostyczno - Lecznicze Barska sp. z o.o. | Wloclawek, Kujawsko-pomorskie, 87-800, Poland Recruiting Site Contact +48542334012 [email protected] Maciej Kowalski, MD Principal Investigator
Niepubliczny Zaklad Opieki Zdrowotnej CENTRUM MEDYCZNE Szpital Swietej Rodziny | Lódz, Lódzkie, 90-302, Poland Recruiting Site Contact +48426393046 [email protected] Maria Wisniewska-Jarosinska, MD, PhD Principal Investigator
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J. | Lódz, Lódzkie, 90-647, Poland Recruiting Site Contact +48422136412 [email protected] Krystyna Stec-Michalska, MD, PhD Principal Investigator
Narodowy Instytut Onkologii im. Marii Skłodowskiej-Curie - Państwowy Instytut Badawczy | Warszawa, Mazowieckie, 02-781, Poland Recruiting Site Contact +48225462328 [email protected] Jaroslaw Regula, PhD Principal Investigator
Niepubliczny Zakład Opieki Zdrowotnej VIVAMED | Warszawa, Mazowieckie, 03-580, Poland Recruiting Site contact +48226792883 [email protected] Robert Petryka, MD Principal Investigator
Miedzyleski Szpital Specjalistyczny w Warszawie | Warszawa, Mazowieckie, 04-749, Poland Recruiting Site Contact +48609040173 [email protected] Maciej Kierzkiewicz Principal Investigator
Uniwersytecki Szpital Kliniczny w Bialymstoku | Bialystok, Podlaskie, 15-276, Poland Recruiting Site Contact +48857468234 [email protected] Andrzej Dabrowski, MD Principal Investigator
Endoskopia Sp. z o.o. | Sopot, Pomorskie, 81-756, Poland Recruiting Site contact +48501011879 [email protected] Marek Horynski, MD Principal Investigator
Szpital Specjalistyczny sw Lukasza - Oddzial Gastroenterologii | Konskie, Swietokrzyskie, 26-200, Poland Recruiting Site Contact +48668699884 [email protected]; [email protected] Iga Detka-Kowalska, MD Principal Investigator
Twoja Przychodnia - Szczecińskie Centrum Medyczne | Szczecin, Zachodniopomorskie, 71-434, Poland Recruiting Site Contact +48603940889 [email protected] Beata Gawdis-Wojnarska, MD Principal Investigator
Szpital Uniwersytecki Nr 2 im. Dr Jana Biziela w Bydgoszczy | Bydgoszcz, 85-168, Poland Recruiting Site Contact +48523655105 [email protected]; [email protected] Maria Klopocka, MD, PhD Principal Investigator
Centrum Medyczne Czestochowa - PRATIA - PPDS | Czestochowa, 42-200, Poland Recruiting Site Contact +48606454256 [email protected] Alina Niska, MD Principal Investigator
Centrum Medyczne Gdynia - PRATIA - PPDS | Gdynia, 81-338, Poland Recruiting Site Contact +48586611003 [email protected] Wojciech Potrzebowski, MD Principal Investigator
NZOZ All Medicus | Katowice, 40-660, Poland Recruiting Site Contact +48323570566 [email protected] Aldona Mularczyk, MD Principal Investigator
Med Gastr Sp.z.o.o Sp.k | Lodz, 91-034, Poland Recruiting Site Contact +48422582223 [email protected] Arkadiusz Mamos Principal Investigator
Instytut Centrum Zdrowia Matki Polki | Lodz, 93-338, Poland Recruiting Site Contact +48422711341 [email protected] Elzbieta Czkwianianc, MD Principal Investigator
Twoja Przychodnia - Centrum Medyczne Nowa Sol | Nowa Sól, 67-100, Poland Recruiting Site Contact +48603940889 [email protected] Malgorzata Miakisz, MD Principal Investigator
Clinical Research Center Spółka z Ograniczoną Odpowiedzialnością, Medic-R Spółka Komandytowa | Poznan, 60-848, Poland Recruiting Site Contact +616579624 [email protected] Marcin Hanczewski, MD, PhD Principal Investigator
Centrum Medyczne Warszawa - PRATIA - PPDS | Rzeszow, 35-068, Poland Recruiting Site Contact +48178755811 [email protected] Karolina Radwan, MD Principal Investigator
Korczowski Bartosz, Gabinet Lekarski | Rzeszow, 35-302, Poland Recruiting Site contact +48177404065 [email protected] Bartosz Korczowski, MD, PhD Principal Investigator
Sonomed Sp. z o.o. | Szczecin, 71-685, Poland Recruiting Site Contact +48914849903 [email protected] Anna Wiechowska-Kozlowska, MD Principal Investigator
Centrum Zdrowia M D M | Warszawa, 00-635, Poland Recruiting Site Contact +48501702899 [email protected] Michal Lawinski, MD Principal Investigator
Centralny Szpital Kliniczny MSW | Warszawa, 02-507, Poland Recruiting Site Contact +48225081240 [email protected] Grazyna Rydzewska, MD, PhD Principal Investigator
BioVirtus Centrum Medyczne | Warszawa, 02-797, Poland Recruiting Site Contact +48607698606 [email protected] Maria Orzeszko, PhD Principal Investigator
Samodzielny Publiczny Szpital Wojewodzki im. Papieza Jana Pawla II | Zamosc, 22-400, Poland Recruiting Site Contact +48846773600 [email protected] Krzysztof Marczewski, MD, PhD Principal Investigator
Hospital Senhora da Oliveira - Guimaraes, E.P.E | Guimarães, 4835-044, Portugal Recruiting Site Contact +351253540330 [email protected] Maria João Moreira, MD Principal Investigator
Hospital da Luz | Lisboa, 1500-650, Portugal Recruiting Site Contact +35217104400 [email protected] Tiago Bana e Costa, MD Principal Investigator
Centro Hospitalar do Algarve - Hospital de Portimao | Portimão, 8500-338, Portugal Recruiting Site Contact +351289891100 [email protected] Helena Sousa, MD Principal Investigator
Sana Monitoring SRL | Bucharest, Bucuresti, 011025, Romania Recruiting Site contact +40722270944 [email protected] Nicoleta-Claudia Cimpoeru, MD Principal Investigator
Cluj-Napoca Emergency Clinical County Hospital | Cluj-Napoca, Cluj, 400006, Romania Recruiting Site contact +40722756475 [email protected] Dan Lucian Dumitrascu, MD, PhD Principal Investigator
Dr.Carol Davila Emergency University Central Military Hospital | Bucharest, 010825, Romania Recruiting Site contact +40723601034 [email protected] Sandica Bucurica, MD Principal Investigator
Colentina Clinical Hospital | Bucharest, 020125, Romania Recruiting Site contact +40213173245 [email protected] Radu-Bogdan Mateescu, MD Principal Investigator
Prof. Dr. Matei Bals Institute of Infectious Diseases | Bucharest, 021105, Romania Recruiting Site contact +40723197880 [email protected] Mihaela Olariu Principal Investigator
Fundeni Clinical Institute | Bucharest, 022328, Romania Recruiting Site contact +40213180455 [email protected] Liliana Gheorghe, PhD Principal Investigator
Emergency University Hospital | Bucharest, 050098, Romania Recruiting Site Contact +40722546405 [email protected] Lucian Negreanu, MD, PhD Principal Investigator
Centrul Medical Hifu Terramed Conformal S.R.L. | Bucuresti, 031864, Romania Recruiting Site contact +40726732764 [email protected] Theodor Voiosu, PhD Principal Investigator
Affidea Romania SRL | Constanta, RO-900591, Romania Recruiting Site contact +40730658188 [email protected] Angelica Stavar, MD Principal Investigator
Gastromedica SRL | Iasi, 700506, Romania Recruiting Site contact +40232264411 [email protected] Carol Stanciu, MD, PhD Principal Investigator
Dr. Tirnaveanu Amelita Private Practice | Oradea, 410066, Romania Recruiting Site contact +40259411049 [email protected] Amelita Tirnaveanu, MD Principal Investigator
Dr. Goldis Gastroenterology Center SRL | Timisoara, 300002, Romania Recruiting Site contact +40256433531 [email protected] Adrian Goldis, MD Principal Investigator
Rostov State Medical University | Rostov-on-Don, 344091, Russian Federation Recruiting Site Contact +78632719705 [email protected] Alexander Tkachev, DMSc, PhD Principal Investigator
Russian Medical Military Academy n.a. S.M. Kirov | Saint Petersburg, Russian Federation Recruiting Site Contact +78122718780 [email protected] Alexander Gordienko, DMSc Principal Investigator
Medical University Reaviz | Samara, 443011, Russian Federation Recruiting Site Contact +78462704947 [email protected] Elena Bunkova, MD Principal Investigator
Private Healthcare Institution Clinical Hospital RZD-Medicina of Samara city | Samara, 443029, Russian Federation Recruiting Site Contact +78469261421 [email protected] Pavel Andreev, PhD Principal Investigator
SHI Regional Clinical Hospital | Saratov, 410012, Russian Federation Recruiting Site Contact +78452224031 [email protected] Olga Reshetko, MD Principal Investigator
St. Elizabeth Municipal Clinical Hospital | St. Petersburg, 195067, Russian Federation Recruiting Site Contact +78125554762 [email protected] Yury Uspenskiy, DMSc, MD, PhD Principal Investigator
Clinical Hospital Center ''Bezanijska Kosa'' | Belgrade, 11080, Serbia Recruiting Site Contact +381641608353 [email protected] Mirjana Cvetkovic, MD Principal Investigator
Clinical Center Nis | Nis, 18000, Serbia Recruiting Site Contact +38118537344 [email protected] Bratislav Petrovic, MD Principal Investigator
General Hospital Vrsac | Vrsac, 26300, Serbia Recruiting Site Contact +381641244198 [email protected] Vladan Petrovic, MD Principal Investigator
Clinical Hospital Center Zemun | Zemun, Serbia Recruiting Site Contact +381648543101 [email protected] Predrag Dugalic, MD Principal Investigator
Clinical Center Kragujevac | Kragujevac, Šumadijski Okrug, 34000, Serbia Recruiting Site Contact +381604401776 [email protected] Natasa Zdravkovic-Petrovic, MD Principal Investigator
KM Management, spol. s r.o. | Nitra, 949 01, Slovakia Recruiting Site Contact +421377415408 [email protected] Milos Gregus, MD, PhD Principal Investigator
Gastro LM, s.r.o. | Presov, 080 01, Slovakia Recruiting Site Contact +421514596400 [email protected] Ivan Bunganic, MD Principal Investigator
CLINRESCO, ARWYP Medical Suites | Johannesburg, Gauteng, 1619, South Africa Recruiting Site contact +27113943400 [email protected] Thomas Coetzer, MD Principal Investigator
Dr. J Breedt | Pretoria, Gauteng, 0084, South Africa Recruiting Site contact +27123354767 [email protected] Johannes Breedt, MBBS Principal Investigator
Dr JP Wright | Claremont, Western Cape, 7708, South Africa Recruiting Site contact +27216834600 [email protected] John Wright, MD Principal Investigator
C.H. Regional Reina Sofia - PPDS | Cordoba, Córdoba, 14004, Spain Recruiting Site Contact +34957011299 [email protected] Eva Maria Iglesias Flores, MD Principal Investigator
Hospital General Universitario Gregorio Maranon | Madrid, Madrid, Communidad Delaware, 28007, Spain Recruiting Site Contact +34915868300 [email protected] Ignacio Marin, MD Principal Investigator
Hospital Universitario de Fuenlabrada | Fuenlabrada, Madrid, 28942, Spain Recruiting Site contact +34916006175 [email protected] Fernando Bermejo San José, MD Principal Investigator
CHUVI - H.U. Alvaro Cunqueiro | Vigo, Pontevedra, 36312, Spain Recruiting Site Contact +34986811157 [email protected] Vicent Hernandez Ramirez Principal Investigator
Centro Medico Teknon - Grupo Quironsalud | Barcelona, 08022, Spain Recruiting Site contact +34933933143 [email protected] Miquel Sans Principal Investigator
Hospital General Juan Ramon Jimenez | Huelva, 21005, Spain Recruiting Site Contact +902505061 [email protected] Hector Pallares Principal Investigator
Hospital Universitario Fundacion Jimenez Diaz | Madrid, 28040, Spain Recruiting Site Contact +915504800 [email protected] Orencio Francisco Bosch Esteva Principal Investigator
Hospital Universitario La Paz - PPDS | Madrid, 28046, Spain Recruiting Site contact +34912071741 [email protected] María Dolores Martín Arranz, MD Principal Investigator
Hospital Universitario Virgen del Rocio - PPDS | Sevilla, 41013, Spain Recruiting Site contact +34600162875 [email protected] Eduardo Leo Carnerero Principal Investigator
Mersin University Medical Faculty | Mersin, 33169, Turkey Recruiting Site Contact +905326145276 [email protected] Engin Altintas, MD Principal Investigator
Regional Municipal Non-profit Enterprise "Chernivtsi Regional Clinical Hospital" | Chernivtsi, Chernivets'ka Oblast, 58001, Ukraine Recruiting Site Contact +380503741659 [email protected] Oleksandr Fediv, MD, PhD Principal Investigator
Municipal Nonprofit Enterprise CCH #2 n.a. prof. O.O. Shalimov of Kharkiv City Council | Kharkiv, Kharkivs'ka Oblast, 61037, Ukraine Recruiting Site Contact +380675708650 [email protected] Olena Datsenko, MD Principal Investigator
Municipal Non-profit Enterprise of Kyiv Regional Council Kyiv Regional Clinical Hospital | Kyiv, Kyïv, 04107, Ukraine Recruiting Site Contact +380506381700 [email protected] Svitlana Danyliuk, MD, PhD Principal Investigator
LLC Medical Center Family Medicine Clinic | Dnipro, 49038, Ukraine Recruiting Site Contact +380661187067 [email protected] Yana Shapovalova Principal Investigator
Communal Non-Commercial Enterprize of Kharkiv Regional Council Regional Clinical Hospital | Kharkiv, 61058, Ukraine Recruiting Site Contact +380504022938 [email protected] Maryna Zinchenko Principal Investigator
CNE Kherson City Clinical Hospital named after Ye. Ye. Karabelesh | Kherson, 73000, Ukraine Recruiting Site Contact +380503966806 [email protected] Alla Malytska, MD Principal Investigator
Medical Center of LLC Medical Clinic Blagomed | Kyiv, 01023, Ukraine Recruiting Site Contact +380505048489 [email protected] Mykhailo Pugach, MD Principal Investigator
Medical Center "OK!Clinic+" of LLC International Clinical Trials Institute | Kyiv, 02091, Ukraine Recruiting Site Contact +380674028636 [email protected] Inna Markevych, MD Principal Investigator
Medical Center of LLC Medical Center Dopomoga-Plus | Kyiv, 02132, Ukraine Recruiting Site contact +380673216127 [email protected] Yurii Zakharash, MD Principal Investigator
Municipal Institution of KRC Kyiv Regional Hospital #2 | Kyiv, 04073, Ukraine Recruiting Site Contact +380676434907 [email protected] Tetiana Lohdanidi, MD Principal Investigator
Municipal Nonprofit Enterprise Lviv Clinical Emergency Care Hospital | Lviv, 79059, Ukraine Recruiting Site Contact +380322528472 [email protected] Mykola Bychkov, MD Principal Investigator
Communal Non-Commercial Enterprise "Vinnytsia City Clinical Hospital №1" | Vinnytsia, 21029, Ukraine Recruiting Site Contact +380672575854 [email protected] Halyna Tomashkevych, MD Principal Investigator
MNPE City Hospital No. 6 of Zaporizhzhia City Council | Zaporizhzhia, 69035, Ukraine Recruiting Site Contact +380662510053 [email protected] Oleksandr Oliinyk Principal Investigator
North Tyneside General Hospital | North Shields, Northumberland, NE29 8NH, United Kingdom Recruiting Site Contact +00443448118111 [email protected] Anthoor Jayaprakash, MD Principal Investigator
Aberdeen Royal Infirmary - PPDS | Aberdeen, AB25 2ZN, United Kingdom Recruiting Site Contact +44012245508804 [email protected] Gillian Bain, MD Principal Investigator
Royal Gwent Hospital - PPDS | Newport, NP20 2UB, United Kingdom Recruiting Site Contact +441633234234 [email protected] Vivek Goel, MD Principal Investigator
New Cross Hospital | Wolverhampton, WV10 0QP, United Kingdom Recruiting Site Contact +441902696452 [email protected] Matthew Brookes, MD Principal Investigator
Ubicacion Paises

Argentina

Australia

Austria

Belgium

Bosnia and Herzegovina

Bulgaria

Colombia

Croatia

Estonia

Germany

Greece

Hungary

Ireland

Israel

Italy

Japan

Korea, Republic of

Lebanon

Lithuania

Mexico

Netherlands

New Zealand

Poland

Portugal

Romania

Russian Federation

Serbia

Slovakia

South Africa

Spain

Turkey

Ukraine

United Kingdom

United States

Fecha de verificación

July 2020

Fiesta responsable

Tipo: Sponsor

Palabras clave
Tiene acceso ampliado No
Condición Examinar
Número de brazos 3
Grupo de brazo

Etiqueta: Ontamalimab 25 mg

Tipo: Experimental

Descripción: Participants will receive 25 mg of ontamalimab subcutaneous (SC) injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).

Etiqueta: Ontamalimab 75 mg

Tipo: Experimental

Descripción: Participants will receive 75 mg of ontamalimab SC injection using a prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).

Etiqueta: Placebo

Tipo: Placebo Comparator

Descripción: Participants will receive placebo matched with ontamalimab SC injection using prefilled syringe once every 4 weeks for 52 weeks; starting at Day/Week 1 Baseline Visit (Week 16 of the SHP647-305 [NCT03559517] or SHP647-306 [NCT03566823]).

Acrónimo CARMEN CD 307
Datos del paciente Yes
Información de diseño del estudio

Asignación: Randomized

Modelo de intervención: Parallel Assignment

Propósito primario: Treatment

Enmascaramiento: Double (Participant, Investigator)

Fuente: ClinicalTrials.gov