Study Stopped
It was decided by Sponsor on 13 January 2014 to terminate study early at primary efficacy endpoint as part of a decision to modify drug development plan.
Telaprevir, Peg-IFN-alfa-2a, and RBV in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C
An Open-Label, Phase 4 Study of Telaprevir, Peginterferon Alfa-2a (Pegasys®), and Ribavirin (Copegus®) in Treatment-Experienced Black/African American and Non-Black/African American Subjects With Genotype 1 Chronic Hepatitis C Who Have Not Achieved a Sustained Viral Response With a Prior Course of Interferon-Based Therapy
1 other identifier
interventional
121
1 country
27
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) in treatment-experienced Black/African American and non-Black/African American participants with Genotype 1 Chronic Hepatitis C (CHC), who have not achieved a sustained viral response with a prior course of interferon-based therapy.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2012
Typical duration for phase_4
27 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 3, 2011
CompletedFirst Posted
Study publicly available on registry
November 8, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2014
CompletedResults Posted
Study results publicly available
June 16, 2015
CompletedAugust 3, 2015
June 1, 2015
2.3 years
November 3, 2011
June 1, 2015
July 13, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Sustained Viral Response 12 Weeks After Last Actual Dose of Study Drug (SVR12)
SVR12 was defined as an undetectable Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (\<lower limit of quantification) at 12 weeks after last actual dose of study drug. The plasma HCV RNA level was measured using Roche TaqMan HCV RNA assay. The lower limit of quantification was 25 international units per milliliter (IU/mL).
12 weeks after last actual dose of study drug (up to Week 60)
Secondary Outcomes (7)
Percentage of Participants With Sustained Viral Response 24 Weeks After Last Actual Dose of Study Drug (SVR24)
24 weeks after last actual dose of study drug (up to Week 72)
Percentage of Participants With Extended Rapid Viral Response (eRVR)
Week 4 and Week 12
Percentage of Participants With Relapse
4 weeks (Wk) (up to Week 52), 12 weeks (up to Week 60) and 24 weeks (up to Week 72) after actual EOT
Percentage of Participants With Virologic Breakthrough
Week 2, 4, 8, and 12
Percentage of Participants With On Treatment Virologic Failure
Week 2, 4, 8, 12, 16, 24, 28, 36, 40, and 48
- +2 more secondary outcomes
Other Outcomes (1)
Plasma Concentration of Telaprevir, Peginterferon Alfa-2a (Peg-IFN) and Ribavirin (RBV)
48 weeks
Study Arms (2)
Black
EXPERIMENTALTelaprevir 750 milligram (mg) tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 microgram per week (mcg/week) subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 milligram per day (mg/day) (for participants weighing \<75 kilograms \[kg\]) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
Non-Black
EXPERIMENTALTelaprevir 750 mg tablet 3 times per day for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day (for participants weighing \<75 kg) or 1200 mg/day (for participants weighing \>=75 kg) for 24 or 48 weeks.
Interventions
Subcutaneous Injection
Eligibility Criteria
You may qualify if:
- Participants self-identify as Black/African American (Group A) or did not self-identify as Black/African American (Group B)
- Participants have Genotype 1 CHC and laboratory evidence of hepatitis C virus (HCV) infection for at least 6 months
- Participants did not achieve sustained viral response 24 weeks after last dose of study drug (SVR24), after at least 1 prior course of Peg-IFN-alfa-2a/RBV therapy of standard duration
You may not qualify if:
- Participants have received previous treatment with telaprevir or any other protease inhibitor(s) for CHC
- Participants who have evidence of hepatic decompensation
- Participants have diagnosed or suspected hepatocellular carcinoma
- Participants have any other cause of significant liver disease in addition to HCV
- Participants are currently abusing illicit drugs or alcohol, or have history of illicit substance or alcohol abuse within 2 years before the screening visit
- Participants who participated in any investigational drug study within 90 days before dosing
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (27)
Alabama
Birmingham, Alabama, United States
California
San Francisco, California, United States
Connecticut
New Haven, Connecticut, United States
Washington, DC
Washington D.C., District of Columbia, United States
Florida
Miami, Florida, United States
Florida
Orlando, Florida, United States
Florida
Tampa, Florida, United States
Florida
West Palm Beach, Florida, United States
Georgia
Atlanta, Georgia, United States
Illinois
Chicago, Illinois, United States
Louisiana
Baton Rouge, Louisiana, United States
Louisiana
New Orleans, Louisiana, United States
Louisiana
Shreveport, Louisiana, United States
Maryland
Baltimore, Maryland, United States
Massachusetts
Boston, Massachusetts, United States
Michigan
Detroit, Michigan, United States
New Jersey
Vineland, New Jersey, United States
New York
New York, New York, United States
New York
The Bronx, New York, United States
North Carolina
Charlotte, North Carolina, United States
North Carolina
Durham, North Carolina, United States
Pennsylvania
Philadelphia, Pennsylvania, United States
Texas
Dallas, Texas, United States
Texas
Houston, Texas, United States
Texas
San Antoinio, Texas, United States
Virginia
Norfolk, Virginia, United States
Washington
Seattle, Washington, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
It was decided by Sponsor on 13 January 2014 to terminate the study early as part of a decision to modify the drug development plan. Eligible participants completed virologic follow-up after termination.
Results Point of Contact
- Title
- Medical Monitor
- Organization
- Vertex Pharmaceuticals Incorporated
Study Officials
- STUDY DIRECTOR
Medical Monitor
Vertex Pharmaceuticals Incorporated
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 3, 2011
First Posted
November 8, 2011
Study Start
January 1, 2012
Primary Completion
May 1, 2014
Study Completion
May 1, 2014
Last Updated
August 3, 2015
Results First Posted
June 16, 2015
Record last verified: 2015-06