Badanie oceniające skuteczność i bezpieczeństwo Mitapivatu u uczestników z zależną od transfuzji talasemią alfa lub beta (α- lub β-TDT) (ENERGIZE-T)
Wieloośrodkowe badanie fazy 3 z podwójnie ślepą próbą, randomizowane, kontrolowane placebo, oceniające skuteczność i bezpieczeństwo stosowania mitapivatu u pacjentów z zależną od transfuzji talasemią alfa lub beta (ENERGIZE-T)
The primary objective of this study was to compare the effect of mitapivat versus placebo on transfusion burden in participants with α- or β-transfusion-dependent thalassemia.
Przegląd badań
Status
Status
Warunki
Warunki
Interwencja / Leczenie
Interwencja / Leczenie
Szczegółowy opis
The mitapivat group included 171 participants. The placebo group included 87 participants.
Typ studiów
Typ studiów
Zapisy (Rzeczywisty)
Zapisy
Faza
Faza
- Faza 3
Kontakty i lokalizacje
Lokalizacje studiów
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Riyadh, Arabia Saudyjska, 14611
- King Abdullah International Medical Research Center
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Riyadh, Arabia Saudyjska, 90210
- King Khalid University Hospital
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Ribeirão Preto, Brazylia, 14051-260
- Hospital Das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
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São Paulo, Brazylia, 04006-002
- GSH Banco de Sangue de São Paulo
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Kyustendil, Bułgaria, 2500
- MHAT "Dr. Nikola Vasiliev" AD
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Pleven, Bułgaria, 5800
- UMHAT "Dr. Georgi Stranski" Pleven
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Plovdiv, Bułgaria, 4002
- UMHAT "Sveti Georgi" EAD
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Sofia, Bułgaria, 1756
- SHATHD Sofia
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Stara Zagora, Bułgaria, 6000
- UMHAT "Prof. Dr. Stoyan Kirkovich"
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Hovedstaden, Dania, 2100
- Rigshospitalet
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Créteil, Francja, 94010
- CHU Hôpital Henri Mondor
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Lyon, Francja, 69003
- Hôpital Edouard Herriot, CHU de Lyon
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Marseille, Francja, 13385
- CHU Hôpital de la Timone
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Paris, Francja, 75015
- Hôpital Necker Enfants Malades
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Achaia, Grecja, 26504
- University General Hospital of Patras
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Athens, Grecja, 11527
- Children's Hospital Agia Sophia, National and Kapodistrian University of Athens Medical School
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Athens, Grecja, 115 26
- Laiko General Hospital
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Ioannina, Grecja, 455 00
- University Hospital of Ioannina
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Thessaloniki, Grecja, 546 42
- Ippokrateio General Hospital
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Barcelona, Hiszpania, 08035
- Hospital Universitario Vall d'Hebron
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Madrid, Hiszpania, 28046
- Hospital Universitario La Paz
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Murcia, Hiszpania, 30120
- Hospital Universitario Virgen Arrixaca
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Seville, Hiszpania, 41013
- Hospital Universitario Virgen del Rocío
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Amsterdam, Holandia, 1105 AZ
- Amsterdam Universitair Medisch Centrum, Locatie AMC
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Utrecht, Holandia, 3584 CX
- Universitair Medisch Centrum Utrecht
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Westzeedijk 353, Holandia, 3015 AA
- Erasmus MC
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Alberta
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Calgary, Alberta, Kanada, T2N 2T9
- Foothills Medical Centre
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Ontario
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Toronto, Ontario, Kanada, M5G 2C4
- Toronto General Hospital, University Health Network
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Beirut, Liban, 9999
- Chronic Care Center
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Alor Star, Malezja, 05460
- Hospital Sultanah Bahiyah
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Johor Bahru, Malezja, 80100
- Hospital Sultanah Aminah Johor Bahru
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Kota Kinabalu, Malezja, 88586
- Hospital Queen Elizabeth, Kota Kinabalu
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Kuala Lumpur, Malezja, 50300
- Hospital Tunku Azizah
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Kuantan, Malezja, 25100
- Hospital Tengku Ampuan Afzan
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Kuching, Malezja, 93586
- Hospital Umum Sarawak
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Pandan Indah, Malezja, 68000
- Hospital Ampang
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Pulau Pinang, Malezja, 10990
- Hospital Pulau Pinang
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Berlin, Niemcy, 13353
- Charité - UB - CVK - Medizinische Klinik
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Essen, Niemcy, 45122
- Universitätsklinikum Essen
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Leipzig, Niemcy, 04103
- Universitätsklinikum Leipzig
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Arizona
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Phoenix, Arizona, Stany Zjednoczone, 85016-7710
- Phoenix Children's Hospital
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California
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La Jolla, California, Stany Zjednoczone, 92093
- San Diego Hospital, UC San Diego Health
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Oakland, California, Stany Zjednoczone, 94609-1809
- Children's Hospital Oakland
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Palo Alto, California, Stany Zjednoczone, 94304-1601
- Stanford Medicine
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Massachusetts
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Boston, Massachusetts, Stany Zjednoczone, 02115
- Boston Children's Hospital
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Michigan
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Detroit, Michigan, Stany Zjednoczone, 48201-2196
- Children's Hospital of Michigan
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New York
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New York, New York, Stany Zjednoczone, 10065-4870
- Weill Cornell Medical Center
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North Carolina
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Durham, North Carolina, Stany Zjednoczone, 27710-3038
- Duke University Medical Center
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Pennsylvania
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Philadelphia, Pennsylvania, Stany Zjednoczone, 19104
- Penn Medicine - University of Pennsylvania Health System
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Washington
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Seattle, Washington, Stany Zjednoczone, 98101
- Seattle Cancer Care Alliance, University of Washington
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Bangkok, Tajlandia, 10400
- Phramongkutklao Hospital
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Bangkok, Tajlandia, 10400
- Ramathibodi Hospital
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Bangkok, Tajlandia, 10700
- Faculty of Medicine Siriraj Hospital
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Chiang Mai, Tajlandia, 50200
- Maharaj Nakorn Chiang Mai Hospital
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Khon Kaen, Tajlandia, 40000
- Srinagarind Hospital, Khon Kaen University
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Mueang Phitsanulok, Tajlandia, 65000
- Naresuan University Hospital
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Pathum Wan, Tajlandia
- King Chulalongkorn Memorial Hospital
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Taipei, Tajwan, 100
- National Taiwan University Hospital
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Adana, Turcja (Türkiye), 1130
- Acibadem Adana Hospital
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Antalya, Turcja (Türkiye), 07059
- Akdeniz University Faculty of Medicine
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Balcalı, Turcja (Türkiye), 01330
- Çukurova University
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Bornova, Turcja (Türkiye), 35040
- Ege University Faculty of Medicine
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Fatih, Turcja (Türkiye), 34093
- Istanbul University Faculty of Medicine
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Mersin, Turcja (Türkiye)
- Hacettepe University
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Brindisi, Włochy, 72100
- Ospedale "A. Perrino" - Brindisi
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Cagliari, Włochy, 09121
- Ospedale Pediatrico Microcitemico
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Ferrara, Włochy, 44124
- Ospedale Sant'Anna
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Genova, Włochy, 16128
- Ente Ospedaliero Ospedali Galliera
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Milan, Włochy, 20122
- Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
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Modena, Włochy, 41124
- A.O.U Di Modena
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Naples, Włochy, 80138
- AOU L. Vanvitelli Universita degli Studi della Campania Luigi Vanvitelli
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Orbassano, Włochy, 10043
- A.O.U. San Luigi Gonzaga
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Abu Dhabi, Zjednoczone Emiraty Arabskie
- Burjeel Medical City
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London, Zjednoczone Królestwo, WC1E 6BT
- University College London
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London, Zjednoczone Królestwo, W12 0HS
- Imperial College Healthcare NHS Trust - Hammersmith Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Greater than or equal to (≥)18 years of age at the time of providing informed consent;
- Documented diagnosis of thalassemia (β-thalassemia with or without α-globin gene mutations, hemoglobin E (HbE)/β-thalassemia, or α-thalassemia/hemoglobin H (HbH) disease) based on deoxyribonucleic acid (DNA) analysis;
- Considered transfusion-dependent, defined as 6 to 20 red blood cells (RBC) units transfused and ≤6-week transfusion-free period during the 24-week period before randomization;
- If taking hydroxyurea, the hydroxyurea dose must be stable for ≥16 weeks before randomization;
- Women of childbearing potential (WOCBP) must be abstinent of sexual activities that may induce pregnancy as part of their usual lifestyle or agree to use two forms of contraception, one of which must be considered highly effective, from the time of providing informed consent, throughout the study, and for 28 days after the last dose of study drug. The second form of contraception can be an acceptable barrier method;
- Written informed consent before any study-related procedures are conducted and willing to comply with all study procedures for the duration of the study.
Exclusion Criteria:
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Pregnant, breastfeeding, or parturient;
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Documented history of homozygous or heterozygous sickle hemoglobin (Hb S) or hemoglobin C (Hb C);
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Prior exposure to gene therapy or prior bone marrow or stem cell transplantation;
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Currently receiving treatment with luspatercept; the last dose must have been administered ≥36 weeks before randomization;
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Currently receiving treatment with hematopoietic stimulating agents; the last dose must have been administered ≥36 weeks before randomization;
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History of malignancy (active or treated) ≤5 years before providing informed consent, except for nonmelanomatous skin cancer in situ, cervical carcinoma in situ, or breast carcinoma in situ;
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History of active and/or uncontrolled cardiac or pulmonary disease ≤6 months before providing informed consent;
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Hepatobiliary disorders;
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Estimated glomerular filtration rate <45 milliliters per minute (mL/min)/1.73 meter (m)^2 by Chronic Kidney Disease Epidemiology Collaboration creatinine equation;
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Nonfasting triglycerides >440 milligrams per deciliter (mg/dL) (5 millimoles per liter [mmol/L]);
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Active infection requiring systemic antimicrobial therapy at the time of providing informed consent;
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Positive test for hepatitis C virus antibody (HCVAb) with evidence of active HCV infection, or positive test for hepatitis B surface antigen (HBsAg);
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Positive test for human immunodeficiency virus (HIV)-1 antibody (Ab) or HIV-2 Ab;
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History of major surgery (including splenectomy) ≤6 months before providing informed consent and/or a major surgical procedure planned during the study;
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Current enrollment or past participation (≤12 weeks before administration of the first dose of study drug or a timeframe equivalent to 5 half-lives of the investigational study drug, whichever is longer) in any other clinical study involving an investigational treatment or device;
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Receiving strong CYP3A4/5 inhibitors that have not been stopped for ≥5 days or a timeframe equivalent to 5 half-lives (whichever is longer); or strong CYP3A4 inducers that have not been stopped for ≥4 weeks or a timeframe equivalent to 5 half-lives (whichever is longer), before randomization;
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Receiving anabolic steroids that have not been stopped for at least 4 weeks before randomization. Testosterone replacement therapy to treat hypogonadism is allowed. The testosterone dose and preparation must be stable for ≥12 weeks before randomization;
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Known allergy, or other contraindication, to mitapivat or its excipients (microcrystalline cellulose, croscarmellose sodium, sodium stearyl fumarate, mannitol, and magnesium stearate, Opadry® II Blue [hypromellose, titanium dioxide, lactose monohydrate, triacetin, and Federal Food, Drug, and Cosmetic (FD&C) Blue #2]);
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Any medical, hematological, psychological, or behavioral condition(s) or prior or current therapy that, in the opinion of the Investigator, may confer an unacceptable risk to participating in the study and/or could confound the interpretation of the study data. Also excluded are:
- Participants who are institutionalized by regulatory or court order
- Participants with any condition(s) that could create undue influence (including but not limited to incarceration, involuntary psychiatric confinement, and financial or familial affiliation with the Investigator or Sponsor).
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Poczwórny
Liczba ramion
Broń i interwencje
Grupa uczestników / ArmGrupa uczestników / Arm |
Interwencja / LeczenieInterwencja / Leczenie |
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Eksperymentalny: Mitapivat
Participants randomized to receive mitapivat 100 milligrams (mg), orally, twice daily (BID) for 48 weeks in the double-blind (DB) period and for up to 5 years in the open label extension (OLE) period. |
Tablets
Inne nazwy:
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Komparator placebo: Placebo
Participants randomized to receive placebo matching mitapivat, orally, BID for 48 weeks in the DB period followed by mitapivat 100 mg, orally, BID for up to 5 years in the OLE period. |
Tablets
Inne nazwy:
Tablets |
Co mierzy badanie?
Podstawowe miary wyniku
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Double-blind Period: Percentage of Participants Who Achieved Transfusion Reduction Response (TRR)
Ramy czasowe: Double-blind Period: Baseline through Week 48
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TRR is defined as ≥50% reduction in transfused red blood cells (RBC) units with a reduction of ≥2 units of transfused RBCs in any consecutive 12-week period through Week 48 compared with baseline transfusion burden standardized to 12 weeks. Baseline transfusion burden standardized to 12 weeks= (12/24) × total number of RBC units transfused during 24-week period before the randomization date for participants randomized and not dosed or the start of study treatment for participants randomized and dosed. Participants withdrawn from the study before Week 12 (Day 85) were considered nonresponders. |
Double-blind Period: Baseline through Week 48
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Miary wyników drugorzędnych
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Okres podwójnie ślepa: stężenie w osoczu mitapivat
Ramy czasowe: Okres podwójnie ślepa: dawka przed 12. tygodniem; Dawka przed 24 tygodniem; Dawki przed dawką, 0,5, 1, 3, 5, 7 godzin po dawce w tygodniu 36
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Okres podwójnie ślepa: dawka przed 12. tygodniem; Dawka przed 24 tygodniem; Dawki przed dawką, 0,5, 1, 3, 5, 7 godzin po dawce w tygodniu 36
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Okres podwójnie ślepa: maksymalne zaobserwowane stężenie w osoczu (CMAX) mitapivat
Ramy czasowe: Okres podwójnie ślepej ślepej: dawka przed dawką, 0,5, 1, 3, 5, 7 godzin po dawce 36
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Okres podwójnie ślepej ślepej: dawka przed dawką, 0,5, 1, 3, 5, 7 godzin po dawce 36
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Okres podwójnie ślepa: czas do maksymalnego zaobserwowanego stężenia w osoczu (TMAX) mitapivat
Ramy czasowe: Okres podwójnie ślepej ślepej: dawka przed dawką, 0,5, 1, 3, 5, 7 godzin po dawce 36
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Okres podwójnie ślepej ślepej: dawka przed dawką, 0,5, 1, 3, 5, 7 godzin po dawce 36
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Okres podwójnie ślepa: czas ostatniego kwantyfikowalnego stężenia (tlast) mitapivat
Ramy czasowe: Okres podwójnie ślepej ślepej: dawka przed dawką, 0,5, 1, 3, 5, 7 godzin po dawce 36
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Okres podwójnie ślepej ślepej: dawka przed dawką, 0,5, 1, 3, 5, 7 godzin po dawce 36
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Okres podwójnie ślepa: stężenie krwi adenozyny trifosforanu (ATP)
Ramy czasowe: Okres podwójnie ślepej ślepej: dawka przed 1 dzień; Dawka przed 12. tygodniem; Dawka przed 24 tygodniem; Dawki przed dawką, 0,5, 1, 3, 5, 7 godzin po dawce w tygodniu 36
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Okres podwójnie ślepej ślepej: dawka przed 1 dzień; Dawka przed 12. tygodniem; Dawka przed 24 tygodniem; Dawki przed dawką, 0,5, 1, 3, 5, 7 godzin po dawce w tygodniu 36
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Okres podwójnie ślepa: stężenie krwi 2,3-difosfoglikanu (2,3-DPG)
Ramy czasowe: Okres podwójnie ślepej ślepej: dawka przed 1 dzień; Dawka przed 12. tygodniem; Dawka przed 24 tygodniem; Dawki przed dawką, 0,5, 1, 3, 5, 7 godzin po dawce w tygodniu 36
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Okres podwójnie ślepej ślepej: dawka przed 1 dzień; Dawka przed 12. tygodniem; Dawka przed 24 tygodniem; Dawki przed dawką, 0,5, 1, 3, 5, 7 godzin po dawce w tygodniu 36
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Double-blind Period: Percentage of Participants Who Achieved TRR2
Ramy czasowe: Double-blind period: Baseline through Week 48
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TRR2, defined as a ≥50% reduction in transfused RBC units in any consecutive 24-week period through Week 48 compared with the 24-week baseline transfusion burden, is reported. Baseline transfusion burden standardized to 24 weeks is the total number of RBC units transfused during the 24-week period before the randomization date for participants randomized and not dosed or the start of study treatment for participants randomized and dosed. Participants withdrawn from the study before Week 24 (Day 169) were considered nonresponders. |
Double-blind period: Baseline through Week 48
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Double-blind Period: Percentage of Participants Who Achieved TRR3
Ramy czasowe: Double-blind period: Baseline up to Week 13 through Week 48
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TRR3, defined as a ≥33% reduction in transfused RBC units from Week 13 through Week 48 compared with the baseline transfusion burden standardized to 36 weeks, is reported. Baseline transfusion burden standardized to 36 weeks= (36/24) × total number of RBC units transfused during the 24-week period before the randomization date for participants randomized and not dosed or the start of study treatment for participants randomized and dosed. Participants withdrawn from the study before Week 48 were considered nonresponders. |
Double-blind period: Baseline up to Week 13 through Week 48
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Double-blind Period: Percentage of Participants Who Achieved TRR4
Ramy czasowe: Double-blind period: Baseline up to Week 13 through Week 48
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TRR4, defined as a ≥50% reduction in transfused RBC units from Week 13 through Week 48 compared with the baseline transfusion burden standardized to 36 weeks, is reported. Baseline transfusion burden standardized to 36 weeks = (36/24) × total number of RBC units transfused during the 24-week period before the randomization date for participants randomized and not dosed or the start of study treatment for participants randomized and dosed. Participants withdrawn from the study before Week 48 were considered nonresponders. |
Double-blind period: Baseline up to Week 13 through Week 48
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Double-blind Period: Percent Change From Baseline in Transfused RBC Units
Ramy czasowe: Double-blind Period: Baseline, Week 13 through Week 48
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Transfusion burden from Week 13 through Week 48 standardized to 36 weeks is defined as number of transfused RBC units from Day 85 through Week 48 in the Double-blind Period ×36/(Number of days from Day 85 through Week 48 in the Double-blind Period/7). Baseline transfusion burden standardized to 36 weeks= (36/24)× is the total number of RBC units transfused during the 24-week period before the randomization date for participants randomized and not dosed or within 168 days before the start of study treatment for participants randomized and dosed. |
Double-blind Period: Baseline, Week 13 through Week 48
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Double-blind Period: Percentage of Participants Who Achieved Transfusion-Independence
Ramy czasowe: Double-blind Period: Baseline through Week 48
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Transfusion-independence is defined as transfusion-free for ≥8 consecutive weeks through Week 48 in the double-blind period. |
Double-blind Period: Baseline through Week 48
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Double-blind Period: Change From Baseline in Iron Levels
Ramy czasowe: Double-blind Period: Baseline through Week 48
|
Iron metabolism was assessed based on Iron levels. |
Double-blind Period: Baseline through Week 48
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Double-blind Period: Change From Baseline in Serum Ferritin Levels
Ramy czasowe: Double-blind Period: Baseline through Week 48
|
Iron metabolism was assessed based on serum ferritin levels. |
Double-blind Period: Baseline through Week 48
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Double-blind Period: Change From Baseline in Total Iron Binding Capacity
Ramy czasowe: Double-blind Period: Baseline through Week 48
|
Iron metabolism was assessed based on total iron binding capacity. |
Double-blind Period: Baseline through Week 48
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Double-blind Period: Change From Baseline in Transferrin Saturation (TSAT) Levels
Ramy czasowe: Double-blind Period: Baseline through Week 48
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Iron metabolism was assessed based on TSAT levels. Transferrin saturation is reported by dividing value of serum iron by total iron binding capacity. |
Double-blind Period: Baseline through Week 48
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Double-blind Period: Number of Participants With Treatment-Emergent Adverse Events (TEAEs), Serious TEAEs, Related TEAEs and TEAEs With Severity Greater Than or Equal to Grade 3
Ramy czasowe: Double-blind Period: From first dose of study drug up to week 48
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An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious & non-serious TEAEs. Severity of AEs was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE. |
Double-blind Period: From first dose of study drug up to week 48
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Open-label Extension Period: Number of Participants With TEAEs, Serious TEAEs, Related TEAEs, Related TEAEs and TEAEs With Severity of Greater Than or Equal to 3
Ramy czasowe: Open-Label Extension Period: From Week 48 up to end of study (approximately 5 years)
|
An AE is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have a causal relationship with the study drug. A serious adverse event (SAE) is any untoward medical occurrence that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAEs are AEs with an initial onset date during the on-treatment period or worsening from baseline and includes both serious & non-serious TEAEs. Severity of abnormalities was evaluated using the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE; Version 4.03): grade 1: mild; grade 2: moderate; grade 3: severe or medically significant but not immediately life-threatening; grade 4: life threatening or disabling; grade 5: death related to AE. |
Open-Label Extension Period: From Week 48 up to end of study (approximately 5 years)
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Double-blind Period: Area Under the Plasma Concentration-time Curve From Time Zero to the Last Measurable Concentration (AUC0-last) of Mitapivat
Ramy czasowe: Double-blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 36
|
Area under the concentration-time curve from time zero to Tlast on dosing day, calculated using the linear-log trapezoidal rule. |
Double-blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose at Week 36
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Double-blind Period: Last Quantifiable Plasma Concentration (Clast) of Mitapivat
Ramy czasowe: Double-blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose Week 36
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Clast is the last quantifiable concentration after a single dose or within the dosing interval (tau) for multiple doses. |
Double-blind Period: Pre-dose, 0.5, 1, 3, 5, 7 hours post-dose Week 36
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Współpracownicy i badacze
Sponsor
Sponsor
Śledczy
Śledczy
- Krzesło do nauki: Medical Affairs, Agios Pharmaceuticals, Inc.
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Zakończenie podstawowe
Ukończenie studiów (Szacowany)
Ukończenie studiów
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Pierwszy wysłany
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia wysłana aktualizacja
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
Inne numery identyfikacyjne badania
- AG348-C-018
- 2021-000212-34 (Numer EudraCT)
- 2024-512747-23-00 (Ctis)
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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