Brief Summary
The purpose of this study is to evaluate the safety and efficacy of a quadruple regimen (VX-222, telaprevir, pegylated interferon, and ribavirin)in subjects with hepatitis C with cirrhosis.
Brief Title
A Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir,Peginterferon-Alfa-2a, Ribavirin) in Subjects With Chronic Hepatitis C With Compensated Cirrhosis
Categories
Completion Date
Completion Date Type
Actual
Conditions
Chronic Hepatitis C Virus
Eligibility Criteria
Inclusion Criteria:
* Subjects must have genotype 1 Chronic Hepatitis C
* Subjects must have compensated cirrhosis
* Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
* Subjects with hemophilia may be permitted to enroll with permission of the medical monitor
Exclusion Criteria:
* Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
* Any contraindication to Peg-IFN or RBV therapy
* Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
* A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines
* Subjects must have genotype 1 Chronic Hepatitis C
* Subjects must have compensated cirrhosis
* Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
* Subjects with hemophilia may be permitted to enroll with permission of the medical monitor
Exclusion Criteria:
* Any previous treatment with an investigational drug or drug regimen for the treatment of hepatitis C, or previous treatment with an approved protease inhibitor
* Any contraindication to Peg-IFN or RBV therapy
* Evidence of hepatic decompensation: history of ascites, hepatic encephalopathy, or bleeding esophageal varices
* A history of acquired immunodeficiency infection, organ transplantation or have an ongoing requirement for immunosuppressive medicines
Inclusion Criteria
Inclusion Criteria:
* Subjects must have genotype 1 Chronic Hepatitis C
* Subjects must have compensated cirrhosis
* Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
* Subjects with hemophilia may be permitted to enroll with permission of the medical monitor
* Subjects must have genotype 1 Chronic Hepatitis C
* Subjects must have compensated cirrhosis
* Subjects may either be treatment naïve, or may have received a course of Peg IFN/RBV without evidence of response. Subjects who are considered to be relapsers to Peg IFN/RBV, or who are partial or null responders will be considered
* Subjects with hemophilia may be permitted to enroll with permission of the medical monitor
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
70 Years
Minimum Age
18 Years
NCT Id
NCT01516918
Org Class
Industry
Org Full Name
Vertex Pharmaceuticals Incorporated
Org Study Id
VX11-222-106
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
Official Title
A Multicenter, Open-Label Phase 2b Pilot Study to Evaluate the Efficacy and Safety of Quadruple Therapy (VX-222, Telaprevir, Peginterferon-Alfa-2, and Ribavirin) in Subjects With Genotype 1 Chronic Hepatitis C With Compensated Cirrhosis
Primary Outcomes
Outcome Measure
The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12)
Outcome Time Frame
12 weeks
Secondary Outcomes
Outcome Time Frame
up to 48 weeks
Outcome Measure
The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments.
Outcome Time Frame
24 weeks
Outcome Measure
The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24)
Outcome Time Frame
up to week 12
Outcome Measure
The proportion of subjects who achieve undetectable HCV RNA at Weeks 2, 4, 8, and 12 after the first dose of study drug, and at the end of planned study drug treatment
Outcome Time Frame
up to 48 weeks
Outcome Measure
The proportion of subjects who have on-treatment virologic failure defined as subjects who either meet a futility rule or who complete the assigned treatment duration and have HCV RNA at the end of study drug treatment
Outcome Description
Proportion of subjects who have SVR12 by IL-28B genotype
Outcome Time Frame
12 weeks
Outcome Measure
The association of the IL-28B genotype with SVR12
Outcome Description
The identity and observed frequency of viral variants as compared to wild-type virus will be measured.
Outcome Time Frame
After the last planned dose of study drug or after time of failure
Outcome Measure
The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure
Outcome Time Frame
12 weeks
Outcome Measure
VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
70
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
John Reinus
Investigator Email
jreinus@montefiore.org
Investigator Phone