Clinical trial NCT01581138: VX-222 + Telaprevir + Ribavirin for 12 or 16 Weeks in Treatment-Naive Subjects With Genotype 1a Hepatitis C
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C Virus
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2012-04-20
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: The proportion of subjects who have a sustained viral response (SVR) at 12 weeks after the last planned dose of treatment
timeFrame: 12 weeks after the last planned dose of treatment
Secondary outcomes:
measure: The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), and laboratory assessments (serum chemistry, hematology, and urinalysis)
timeFrame: up to 20 weeks
measure: The proportion of subjects who have an SVR 24 weeks after the last planned dose of the study drug
timeFrame: 24 weeks after the last planned dose of the study drug
measure: The proportion of subjects who have an SVR 4 weeks after the last planned dose of the study drug
timeFrame: 4 weeks after the last planned dose of the study drug
measure: 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)
timeFrame: 48 weeks either after the last planned dose of study drug or after time of failure
measure: 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)
timeFrame: up to 16 weeks
measure: Time to achieve <LLOQ undetectable HCV RNA
timeFrame: up to 16 weeks
measure: The proportion of subjects who have on-treatment virologic failure defined as subjects who either have viral breakthrough or who complete the assigned treatment and have ≥LLOQ HCV RNA at the end of study drug treatment (EOT)
timeFrame: up to 16 weeks
measure: The association of the interleukin-28B (IL-28B) genotype (CC versus CT versus TT) with SVR12
timeFrame: 12 weeks after the last planned dose of treatment
measure: The amino acid sequence of the nonstructural (NS)3/4A and NS5B proteins in subjects who have treatment failure
timeFrame: 48 weeks either after the last planned dose of study drug or after time of failure
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Anaheim
country: United States
state: California
city: Riverside
country: United States
state: California
city: San Diego
country: United States
state: California
city: Englewood
country: United States
state: Colorado
city: Orlando
country: United States
state: Florida
city: Marietta
country: United States
state: Georgia
city: Baltimore
country: United States
state: Maryland
city: New York
country: United States
state: New York
city: Asheville
country: United States
state: North Carolina
city: Winston-Salem
country: United States
state: North Carolina
city: Cincinatti
country: United States
state: Ohio
city: Pittsburgh
country: United States
state: Pennsylvania
city: Germantown
country: United States
state: Tennessee
city: Nashville
country: United States
state: Tennessee
city: Austin
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References: