VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
A Multicenter, Randomized, Open-label, Phase 2b Study to Evaluate the Efficacy and Safety of Two Regimens of All-oral Triple Therapy (VX-222 in Combination With Telaprevir [Incivek™] and Ribavirin [Copegus®]) in Treatment-Naïve Subjects With Genotype 1a Chronic Hepatitis C
1 other identifier
interventional
64
1 country
18
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of two all oral regimens in subjects who have chronic hepatitis C and have not received treatment yet.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
Started Jul 2012
Shorter than P25 for phase_2
18 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 17, 2012
CompletedFirst Posted
Study publicly available on registry
April 20, 2012
CompletedStudy Start
First participant enrolled
July 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedJuly 4, 2014
July 1, 2014
11 months
April 17, 2012
July 2, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment
12 weeks after the last planned dose of treatment
Secondary Outcomes (9)
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)
up to 20 weeks
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug
24 weeks after the last planned dose of the study drug
The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug
4 weeks after the last planned dose of the study drug
The proportion of subjects who relapse (i.e., who had <lower limit of quantitation LLOQ hepatitis C virus (HCV) RNA at the end of planned study drug treatment (planned EOT) followed by ≥LLOQ HCV RNA after planned EOT)
48 weeks either after the last planned dose of study drug or after time of failure
The proportion of subjects who achieve undetectable HCV RNA (below the lower limit of detection (< (LLOQ) undetectable) at Weeks 2, 4, 8, 12, and 16 after the first dose of study drug, and <LLOQ at the end of planned study drug treatment (planned EOT)
up to 16 weeks
- +4 more secondary outcomes
Study Arms (2)
12 week treatment
EXPERIMENTAL16 week treatment
EXPERIMENTALInterventions
1125 mg tablets twice daily for oral administration
1000 mg per day for subjects weighing \<75 kg and 1200 mg per day for subjects weighing ≥75 kg, dosed twice daily
Eligibility Criteria
You may qualify if:
- Subjects must have genotype 1 chronic hepatitis C (CHC) and laboratory evidence of HCV infection for at least 6 months before the Screening Visit
- Subjects will be treatment naïve
- Subjects must have documentation of the presence or absence of cirrhosis
You may not qualify if:
- History or other clinical evidence of significant or unstable cardiac disease
- Evidence of hepatic decompensation
- Diagnosed or suspected hepatocellular carcinoma
- Any other cause of significant liver disease in addition to hepatitis C, which may include but is not limited to malignancy with hepatic involvement, hepatitis B, drug-or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, nonalcoholic steatohepatitis, or primary biliary cirrhosis
- History of organ transplant, with the exception of corneal transplants and skin grafts
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (18)
Unknown Facility
Birmingham, Alabama, United States
Unknown Facility
Anaheim, California, United States
Unknown Facility
Riverside, California, United States
Unknown Facility
San Diego, California, United States
Unknown Facility
Englewood, Colorado, United States
Unknown Facility
Orlando, Florida, United States
Unknown Facility
Marietta, Georgia, United States
Unknown Facility
Baltimore, Maryland, United States
Unknown Facility
New York, New York, United States
Unknown Facility
Asheville, North Carolina, United States
Unknown Facility
Winston-Salem, North Carolina, United States
Unknown Facility
Cincinnati, Ohio, United States
Unknown Facility
Pittsburgh, Pennsylvania, United States
Unknown Facility
Germantown, Tennessee, United States
Unknown Facility
Nashville, Tennessee, United States
Unknown Facility
Austin, Texas, United States
Unknown Facility
San Antonio, Texas, United States
Unknown Facility
Norfolk, Virginia, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Monitor
Vertex Pharmaceuticals Incorporated
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 17, 2012
First Posted
April 20, 2012
Study Start
July 1, 2012
Primary Completion
June 1, 2013
Study Completion
December 1, 2013
Last Updated
July 4, 2014
Record last verified: 2014-07