Clinical trial NCT01516918: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C Virus
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2012-01-25
Enrollment: 103
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: The proportion of subjects who have a sustained virologic response at 12 weeks after the last planned dose of treatment (SVR12)
timeFrame: 12 weeks
Secondary outcomes:
measure: The safety and tolerability as assessed by adverse events, vital signs, 12-lead electrocardiograms and laboratory assessments.
timeFrame: up to 48 weeks
measure: The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug (SVR24)
timeFrame: 24 weeks
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
timeFrame: up to week 12
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
timeFrame: up to 48 weeks
measure: The association of the IL-28B genotype with SVR12
timeFrame: 12 weeks
measure: The amino acid sequence of the nonstructural (NS)3 and NS5B proteins in subjects who have treatment failure
timeFrame: After the last planned dose of study drug or after time of failure
measure: VX-222, telaprevir, and RBV plasma concentrations and Peg-IFN serum concentrations
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: San Diego
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Bradenton
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Tampa
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Chicago
country: United States
state: Illinois
city: Indianapolis
country: United States
state: Indiana
city: Boston
country: United States
state: Massachusetts
city: Detroit
country: United States
state: Michigan
city: Lebanon
country: United States
state: New Hampshire
city: Egg Harbor Township
country: United States
state: New Jersey
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: Rochester
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Providence
country: United States
state: Rhode Island
city: Germantown
country: United States
state: Tennessee
city: Arlington
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Vancouver
country: Canada
state: British Columbia
city: London
country: Canada
state: Ontario
city: Montreal
country: Canada
state: Quebec
city: Hamburg
country: Germany
city: Heidelberg
country: Germany
city: Hessen
country: Germany
city: Koeln
country: Germany
city: Saschen
country: Germany
city: Stuttgart
country: Germany
city: Bialystok
country: Poland
city: Myslowice
country: Poland
city: Wroclaw
country: Poland
city: London
country: United Kingdom
city: Plymouth
country: United Kingdom
city: Scotland
country: United Kingdom
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References: