Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

An Observational Study of Peginterferon (e.g. Pegasys)-Based Direct Acting Antiviral Triple Therapy in Patients With Chronic Hepatitis C Genotype 1

10 maart 2017 bijgewerkt door: Hoffmann-La Roche

Non-Interventional, Prospective Cohort Study of the Effectiveness, Safety and Utilization of Two Approved Pegylated Interferon-Based Direct Acting Antiviral Triple Therapies in the Management of Genotype 1 Chronic Hepatitis C in Routine Clinical Practice in the USA

This prospective observational study will evaluate the efficacy and safety of two approved pegylated interferon-based direct acting antiviral triple therapies in patients with chronic hepatitis C genotype 1. Patients receiving pegylated interferon (e.g. Pegasys) and ribavirin plus either telaprevir or boceprivir in accordance with local standard of care and US labeling will be followed for the duration of their treatment and for up to 24 weeks post-treatment.

Studie Overzicht

Toestand

Voltooid

Conditie

Hepatitis C, chronisch

Studietype

Observationeel

Inschrijving (Werkelijk)

672

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

Puerto Rico
- - San Juan, Puerto Rico, 00927
    - Fundacion De Investigacion de Diego
Verenigde Staten
- Alabama
  - Birmingham, Alabama, Verenigde Staten, 35233
    - Cooper Green Hospital
  - Birmingham, Alabama, Verenigde Staten, 35233
    - Univ. of Alabama at Birmingham; The Kirklin Clinic
- Arkansas
  - Little Rock, Arkansas, Verenigde Staten, 72205
    - Liver Wellness Center
- California
  - Loma Linda, California, Verenigde Staten, 92354
    - Loma Linda University Medical Center and Liver Center
  - Pasadena, California, Verenigde Staten, 91105
    - HMRI Liver Center
  - San Diego, California, Verenigde Staten, 92161
    - VA San Diego Healthcare System
  - San Diego, California, Verenigde Staten, 92154
    - Kaiser Permanente San Diego; Hepatology Research
  - Torrance, California, Verenigde Staten, 90505
    - South Bay Gastroenterology Medical Group
- Colorado
  - Aurora, Colorado, Verenigde Staten, 80045
    - University of Colorado Denver
- Connecticut
  - Torrington, Connecticut, Verenigde Staten, 06790
    - Litchfield County Gastroenterology Associates
- Florida
  - Daytona Beach, Florida, Verenigde Staten, 32117
    - Consultive Medicine
  - Largo, Florida, Verenigde Staten, 33777
    - Florida Center for Gastroenterology
  - Maitland, Florida, Verenigde Staten, 32751
    - Center For Advanced Gastroenterology
  - Orlando, Florida, Verenigde Staten, 32806
    - Internal Medicine Specialists
  - Orlando, Florida, Verenigde Staten, 32806
    - Orlando Infectious Disease Center, Pa
  - Tampa, Florida, Verenigde Staten, 33606
    - Tampa General Hospital; Tampa General Medical Group
- Georgia
  - Decatur, Georgia, Verenigde Staten, 30033
    - Atlanta Center for Gastroenterology, PC
  - Decatur, Georgia, Verenigde Staten, 30033
    - Dekalb Gastroenterology Associates
  - Macon, Georgia, Verenigde Staten, 31201
    - Gastroenterology Associates of Central Georgia
- Illinois
  - Chicago, Illinois, Verenigde Staten, 60637
    - University of Chicago
- Indiana
  - Indianapolis, Indiana, Verenigde Staten, 46237
    - Indianapolis Gastroenterology
- Kentucky
  - Crestview Hills, Kentucky, Verenigde Staten, 41017
    - Tristate Gastroenerology Associates
- Louisiana
  - Baton Rouge, Louisiana, Verenigde Staten, 70809
    - Ochsner Clinic Foundation
  - Metairie, Louisiana, Verenigde Staten, 70006
    - New Orleans Research Institute.
  - New Orleans, Louisiana, Verenigde Staten, 70112-2699
    - Tulane Uni Health Sciences Center
- Maryland
  - Baltimore, Maryland, Verenigde Staten, 21202
    - Mercy Medical Center; Institute For Digestive Health And Liver Disease
- Massachusetts
  - Brockton, Massachusetts, Verenigde Staten, 02302
    - Commonwealth Clinical Studies
  - Springfield, Massachusetts, Verenigde Staten, 01199
    - Baystate Infectious Diseases Clinical Research
  - Worcester, Massachusetts, Verenigde Staten, 01068
    - Partners in Internal Medicine
- Michigan
  - Detroit, Michigan, Verenigde Staten, 48201
    - Harper University Hospital/Wayne State
  - Wyoming, Michigan, Verenigde Staten, 49519
    - Gastroenterology Associates of Western Michigan
- Minnesota
  - Rochester, Minnesota, Verenigde Staten, 55905
    - Mayo Clinic Rochester
- Missouri
  - Kansas City, Missouri, Verenigde Staten, 64111
    - St. Luke's Hospital
  - Kansas City, Missouri, Verenigde Staten, 64128
    - Midwest Biomedical Research Foundation
  - St. Louis, Missouri, Verenigde Staten, 63104
    - Saint Louis University Gastroenterology & Hepatology; Clinical Research Unit
- New Hampshire
  - Lebanon, New Hampshire, Verenigde Staten, 03756
    - Dartmouth Hitchcock Med Center
- New Jersey
  - Haddon Heights, New Jersey, Verenigde Staten, 08035
    - Lourdes Medical Associates; Southern New Jersey Center for LIver Disease
  - Morristown, New Jersey, Verenigde Staten, 07960
    - Atlantic Research Affiliates
  - Twp, New Jersey, Verenigde Staten, 08234
    - AGA Clinical Research Associates, LLC
- New York
  - Bronx, New York, Verenigde Staten, 10467
    - Montefiore Medical Center
  - Brooklyn, New York, Verenigde Staten, 11215
    - New York Methodist Hospital
  - Catskill, New York, Verenigde Staten, 12414
    - Mountainview Medical Practice
  - Flushing, New York, Verenigde Staten, 11355
    - New Discovery, LLC
  - Manhasset, New York, Verenigde Staten, 11030
    - North Shore University Hospital
  - New York, New York, Verenigde Staten, 10016
    - Concorde Medical Group
  - Rochester, New York, Verenigde Staten, 14642
    - University of Rochester Medical Center
- North Carolina
  - Asheville, North Carolina, Verenigde Staten, 28801
    - Asheville Gastroenterology Associates, P.A.
  - Durham, North Carolina, Verenigde Staten, 27710
    - Duke Univ Medical Center
  - Rocky Mount, North Carolina, Verenigde Staten, 27804
    - Boice-Willis Clinic
- Oklahoma
  - Oklahoma City, Oklahoma, Verenigde Staten, 73112
    - Integris Baptist Medical Center
- Oregon
  - Bend, Oregon, Verenigde Staten, 97701
    - Bend Memorial Clinic
- Pennsylvania
  - DuBois, Pennsylvania, Verenigde Staten, 15801
    - Dubois Regional Medical Center
  - Philadelphia, Pennsylvania, Verenigde Staten, 19107
    - Thomas Jefferson University
  - Philadelphia, Pennsylvania, Verenigde Staten, 19140
    - Temple University Hospital
  - Philadelphia, Pennsylvania, Verenigde Staten, 19141
    - Albert Einstein Medical Center; Division of Hepatology
- Tennessee
  - Memphis, Tennessee, Verenigde Staten, 38104
    - Methodist Heathcare University Hospital
- Texas
  - Austin, Texas, Verenigde Staten, 78758
    - Imtiaz Alam MD, P.A. - Private Practice
  - Dallas, Texas, Verenigde Staten, 75203
    - Methodist Transplant Physicians
  - Galveston, Texas, Verenigde Staten, 77555
    - Univ of Texas Medical Branch
  - Houston, Texas, Verenigde Staten, 77005
    - Kelsey Research Foundation
  - Houston, Texas, Verenigde Staten, 77030
    - Liver Associates of Texas
  - Houston, Texas, Verenigde Staten, 77090
    - Digestive And Liver Disease Consultants, PA
- Vermont
  - Burlington, Vermont, Verenigde Staten, 5401
    - University of Vermont
- Virginia
  - Charlottesville, Virginia, Verenigde Staten, 22908
    - University of Virginia Health System: Gastroenterology at UVA
  - Fairfax, Virginia, Verenigde Staten, 22031
    - Metropolitan Research

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar en ouder (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Kanssteekproef

Studie Bevolking

Patients with chronic hepatitis C genotype 1 receiving pegylated interferon-based direct acting antiviral triple therapies in the US

Beschrijving

Inclusion Criteria:

Adult patients, >/= 18 years of age
Chronic hepatitis C, genotype 1
Receiving pegylated interferon-based direct acting antiviral therapy (pegylated interferon and ribavirin plus either telaprevir or boceprivir) in accordance with local standard of care and US labeling

Exclusion Criteria:

Contraindications per US labels

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Aantal groepen / cohorten

Cohorten en interventies

Groep / Cohort
Cohort

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Time to Premature Treatment Discontinuation Due to Any Reason Tijdsspanne: Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)	Time to premature treatment discontinuation for any reason (weeks) was calculated as follows: date of treatment discontinuation for any reason - first treatment administration date + 1/7. The estimated survivorship curves were obtained from Kaplan-Meier maximum likelihood estimates for each treatment group. Participants who completed the study treatment (including those who shorten the treatment based on response-guided therapy) were censored on their last dosing date.	Up to the treatment discontinuation or the date of the last dosing for participants who were ongoing or completed the study treatment (including those who shorten the treatment based on response-guided therapy)
Number of Participants With Sustained Virologic Response (SVR) at 12 Weeks or Later After Completion of the Treatment Period Tijdsspanne: 12 weeks or later post-completion of the treatment period	SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period	12 weeks or later post-completion of the treatment period

Secundaire uitkomstmaten

Uitkomstmaat	Maatregel Beschrijving	Tijdsspanne
Number of Participants With Virologic Response (VR) Tijdsspanne: Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period	VR was defined as undetectable HCV RNA (i.e.,HCV RNA less than 50 IU/mL)	Weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, and 48; and 12 weeks post-completion of treatment period
Number of Participants With VR by Categories of Very Rapid VR (VRVR), Rapid Virological Response (RVR), VR Week 8, Early Virological Response (cEVR), Partial Virological Response (pEVR), and None of the Above Tijdsspanne: Weeks 2, 4, 8, and 12	VRVR was defined as HCV RNA < 50 IU/mL at treatment Week 2; RVR as HCV RNA < 50 IU/mL by treatment Week 4, but no HCV RNA < 50 IU/mL at Week 2; Week 8 VR as HCV RNA < 50 IU/mL by study Week 8 but no HCV RNA < 50 IU/mL at Weeks 2 to 4; cEVR as HCV RNA < 50 IU/mL by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 8; and pEVR as at least a 2 log10 decrease in HCV RNA by treatment Week 12 but no HCV RNA < 50 IU/mL at Weeks 2 to 12.	Weeks 2, 4, 8, and 12
Number of Participants Who Achieved Extended VR, Virologic Breakthrough/Rebound, Virologic Relapse, and Who Were Non-responder Tijdsspanne: Up to Week 48	The extended VR is defined as initial HCV RNA < 50 IU/mL during Weeks 2 to 24 and remaining HCV RNA < 50 IU/mL at all subsequent assessments; virologic breakthrough/rebound is defined as detectable HCV RNA during the treatment period in participants with prior non-detectable HCV RNA or increase of HCV RNA by >=1 log10 above nadir for direct-acting antiviral (DAA) tripe therapies (PegIFN + RBV + TEL or PegIFN + RBV + BOC); virologic relapse is defined as detectable HCV RNA during the treatment-free follow-up period in participants with HCV RNA < 50 IU/mL at EoT; non-responder is defined as participants who never achieved undetectable HCV-RNA during the 48 weeks of treatment.	Up to Week 48
Predictors of Sustained Virologic Response by Week Tijdsspanne: Weeks 2, 4, 6, 8, and 12	SVR rate defined as the number of participants with undetectable HCV RNA (i.e., HCV RNA less than 50 IU/mL) at 12 weeks or later post-completion of the treatment period. The predictors defined as participants with virological response (HCV RNA < 50 IU/mL at any visit), or with virological response at Week 12 (HCV-RNA < 50 IU/mL or unquantifiable or HCV-RNA >=2 log10 drop from baseline). Positive predictive value is the probability that participants with a positive screening test truly have the disease. Negative predictive value is the probability that participants with a negative screening test truly don't have the disease.	Weeks 2, 4, 6, 8, and 12
Number of Participants With SVR by Subgroups (Demographic and Baseline Factors) Tijdsspanne: Week 12	Participants for VR to prior therapy (PegIFN + RBV) were categorized as: relapse (who completed the previous treatment with HCV RNA undetectable, but relapsed with detectable HCV RNA once treatment was discontinued), breakthrough (HCV RNA undetectable, followed by detectable HCV RNA during on-treatment period), null responder (completed at least 12 weeks of treatment with HCV RNA decrease < 2 log10 at Week 12), partial responder (HCV RNA decrease > 2 log10 by Week 12 of treatment and HCV RNA remained detectable), unknown response (completed previous treatment, but treatment response based on HCV RNA determinations was not available), and prior intolerant (treated previously, but discontinued due to adverse event or participant's choice prior to completion of therapy). Participants categorized into 3 genotypes (CC, CT and TT) based on single nucleotide polymorphism in the Interleukin 28B (IL28B) gene.	Week 12
Duration of Viral Undetectability During Treatment for Participants With HCV RNA Undetectable During Treatment by Trial Treatment Tijdsspanne: Up to Week 48	The undetectable HCV RNA means HCV RNA values less than 50 IU/mL. This outcome measure was calculated as the duration of participant's first date of undetectable HCV RNA and the date of the participant's last dose.	Up to Week 48
Time to Premature Treatment Discontinuation Due to Lack of Efficacy Tijdsspanne: Up to Week 48	The participants discontinued the study treatment due to lack of efficacy of study treatment. Time to premature treatment discontinuation due to lack of efficacy (weeks) = (date of treatment discontinuation due to lack of efficacy - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.	Up to Week 48
Time to Premature Treatment Discontinuation Due to Intolerance Tijdsspanne: Up to Week 48	The participants discontinued the study treatment due to intolerance of the study treatment. Time to premature treatment discontinuation due to intolerance (weeks) = (date of treatment discontinuation due to lack of intolerance - first treatment administration date + 1)/7. Participants who were ongoing or completed the study treatment (including those who shortened the treatment based on response-guided therapy) were censored at the date of their last dosing.	Up to Week 48
Treatment Duration, as Measure of Extent of Exposure to Study Medication Tijdsspanne: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)	Extent of exposure is defined as the duration of the treatment administered during the study. The mean duration of exposure to PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir is calculated as the number of weeks between the start and end of treatment.	From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)
Mean Cumulative Dose, as Measure of Extent of Exposure to Study Medication Tijdsspanne: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)	Extent of exposure is defined as the duration of the treatment administered during the study. The mean cumulative doses of PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir were presented.	From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)
Percentage of Dose Reduction, as Measure of Extent of Exposure to Study Medication Tijdsspanne: From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)	Extent of exposure is defined as the duration of the treatment administered during the study. Degree of dose reduction was calculated as actual exposure/target exposure × 100%. Target exposure was defined as the actual received treatment duration multiplied by the initial assigned dose. Actual exposure was defined as cumulative dose during the treatment period.	From the date of the first dose of the study drug up to withdrawal/study completion (up to Study Week 48)
Compliance of Study Treatment Tijdsspanne: Weeks 4, 8, 12, and 24	Compliance was assessed based on the number of participants who received the planned study treatment (PegIFN alfa-2a, PegIFN alfa-2b, ribavirin, telaprevir, and boceprevir) during the treatment period.	Weeks 4, 8, 12, and 24
Number of Participants Treated With PegIFN, RBV, and TEL as Per the U.S. Label Tijdsspanne: Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy)	As per the U.S. labeling, participants with treatment-naive, prior relapse (TN-PR) and prior partial or null responder (PP/NR) received PegIFN + RBV + TEL (triple therapy) for 12 weeks; followed additional 12 or 36 weeks of PegIFN + RBV (dual therapy) depending on viral response and prior response status.	Up to 48 weeks (included 12 weeks of triple therapy + additional 12/36 weeks of dual therapy)
Number of Participants Treated With PegIFN, RBV, and BOC as Per the U.S. Label Tijdsspanne: Up to 48 weeks (included 4 weeks of dual therapy + additional 28/36 weeks of triple therapy and/or additional dual therapy up to Week 48)	As per the U.S. labeling, participants with cirrhosis (C); non-cirrhotic/treatment-naïve (NC/TN); and non-cirrhotic/previous partial responders or relapsers (NC/PPR or R) received first 4 weeks of dual therapy, followed by additional 28 or 36 weeks of PegIFN + RBV + BOC (triple therapy) and/or then completed dual therapy through Week 48 depending on viral response and prior response status.	Up to 48 weeks (included 4 weeks of dual therapy + additional 28/36 weeks of triple therapy and/or additional dual therapy up to Week 48)
Number of Participants With Safety-related Dose Reductions Tijdsspanne: Up to 48 weeks	The dose reduction was done because of safety-related reasons (AEs) including alanine aminotransferase disorder, anemia, neutropenia, thrombocytopenia, and rash.	Up to 48 weeks
Number of Participants With Premature Treatment Discontinuation Due to Adverse Events (AEs) Tijdsspanne: Up to 48 weeks	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product.	Up to 48 weeks
Number of Participants With Any AEs and Serious Adverse Events (SAEs) Tijdsspanne: Up to 12 weeks post-treatment	An AE is defined as any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered to be related to the medicinal product. An SAE is any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or results in a congenital anomaly/birth defect.	Up to 12 weeks post-treatment
Change From Baseline in Work Loss And Productivity Outcomes (WPAI) Tijdsspanne: Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment	WPAI-AS is a 6-question participant rated questionnaire to determine the amount of absenteeism, presenteeism, work productivity loss and daily activity impairment attributable to ankylosing spondylitis for a period of 7 days prior to each visit. It yields 4 sub-scores: work time missed (absenteeism), impairment while working (presenteeism or reduced on-the-job effectiveness), overall work impairment (work productivity loss or absenteeism plus presenteeism) and activity impairment (daily activity impairment). Each sub-scores was scaled as 0 (not affected/no impairment) to 10 (completely affected/impaired). Higher scores indicated greater impairment and less productivity.	Baseline (Day 1 ), Weeks 2, 4, 6, 8, 12, 16, 24, 36, 48, 12 weeks post-treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Hoffmann-La Roche

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start (Werkelijk)

31 januari 2012

Primaire voltooiing (Werkelijk)

31 maart 2014

Studie voltooiing (Werkelijk)

31 maart 2014

Studieregistratiedata

Eerst ingediend

9 januari 2012

Eerst ingediend dat voldeed aan de QC-criteria