Clinical trial NCT01459913: Efficacy of a 12-Week Regimen of Telaprevir, Pegylated Interferon, and Ribavirin in Treatment-Naive and Prior Relapser Subjects With Interleukin28B (IL28B) CC Genotype
Official title: A Phase 3b Study of 2 Treatment Durations of Telaprevir, Peg-IFN (Pegasys®), and Ribavirin (Copegus®) in Treatment-Naive and Prior Relapser Subjects With Genotype 1 Chronic Hepatitis C and IL28B CC Genotype
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Hepatitis C, Chronic
Keywords: VX-950
INCIVEK
INCIVO
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2011-10-26
Enrollment: 239
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 if a 12-week total regimen of telaprevir in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) and ribavirin (RBV) (T12/PR12) is safe and effective in subjects who have the interleukin-28B (IL28B) CC genotype. The subjects enrolled in this study will have chronic hepatitis C virus (HCV) infection and will not have cirrhosis of the liver.


Eligibility criteria: Inclusion Criteria:

* Male and female subjects, 18 to 70 years of age, inclusive
* Treatment-naive OR subjects (prior relapsers) may be included who did not achieve sustained viral response 24 weeks after last planned dose of study drug (SVR24) after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and had a documented undetectable HCV RNA level at the planned end of treatment of at least 42-week duration
* Subjects have IL28B CC genotype determined during screening
* Subjects have genotype 1 chronic hepatitis C and laboratory evidence of HCV infection for at least 6 months, defined by (1) documented HCV serology test at least 6 months before the first screening visit demonstrating the presence of anti-HCV antibody, or (2) documented presence of HCV RNA by a sensitive and specific assay at least 6 months before the first screening visit, or (3) documented histologic evidence of chronic hepatitis C demonstrated by fibrosis on a standardized histologic grading system at least 6 months before the first screening visit. If only inflammation is present in the liver histologic report, then 6 months of laboratory evidence is required

Exclusion Criteria:

* Subjects have received previous treatment with telaprevir or any other protease inhibitor(s) for chronic hepatitis C
* Subjects who did not achieve SVR24 after at least 1 prior course of Peg-IFN/RBV therapy of standard duration and never achieved undetectable HCV RNA while on treatment
* Subjects have evidence of hepatic decompensation
* Subjects have evidence of cirrhosis
* Subjects have diagnosed or suspected hepatocellular carcinoma
* Subjects have 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. Steatosis is allowed if clinically asymptomatic

Primary outcomes:
measure: Percentage of Subjects With Sustained Viral Response 12 Weeks After Last Planned Dose of Study Drug (SVR12)
timeFrame: 12 weeks after last planned dose of study drug (up to Week 36)
Secondary outcomes:
measure: Percentage of Subjects With Sustained Viral Response 4 Weeks After Last Planned Dose of Study Drug (SVR4)
timeFrame: 4 weeks after last planned dose of study drug (up to Week 28)
measure: Percentage of Subjects With Sustained Viral Response 24 Weeks After Last Planned Dose of Study Drug (SVR24)
timeFrame: 24 weeks after last planned dose of study drug (up to Week 48)
measure: Percentage of Subjects With Sustained Viral Response at Week 72 (SVR72)
timeFrame: Week 72
measure: Percentage of Subjects With Viral Relapse
timeFrame: After last dose of study drug up to 4 weeks (up to Week 28), 12 weeks (up to Week 36), 24 weeks (up to Week 48) antiviral follow-up
measure: Percentage of Subjects With On-Treatment Virologic Failure
timeFrame: Baseline up to Week 48
measure: Number of Subjects With Rapid Viral Response (RVR)
timeFrame: Week 4
measure: Number of Subjects With Extended Rapid Viral Response (eRVR)
timeFrame: Week 4 and Week 12
measure: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 48
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Birmingham
country: United States
state: Alabama
city: Phoenix
country: United States
state: Arizona
city: La Jolla
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
facility: California
state: California
city: Sacramento
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Diego
country: United States
state: California
city: San Francisco
country: United States
facility: California
state: California
city: Farmington
country: United States
state: Connecticut
city: New Haven
country: United States
state: Connecticut
city: Bradenton
country: United States
state: Florida
city: Gainesville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Jacksonville
country: United States
state: Florida
city: Orlando
country: United States
state: Florida
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Honolulu
country: United States
state: Hawaii
city: Chicago
country: United States
state: Illinois
city: Chicago
country: United States
state: Illinois
city: Baltimore
country: United States
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Columbia
country: United States
state: Maryland
city: Boston
country: United States
state: Massachusetts
city: Brockton
country: United States
state: Massachusetts
city: Burlington
country: United States
state: Massachusetts
city: Worcester
country: United States
state: Massachusetts
city: Novi
country: United States
state: Michigan
city: Kansas City
country: United States
state: Missouri
city: Lebanon
country: United States
state: New Hampshire
city: Egg Harbor Township
country: United States
state: New Jersey
city: Vineland
country: United States
state: New Jersey
city: Flushing
country: United States
state: New York
city: Manhasset
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: New York
country: United States
state: New York
city: Chapel Hill
country: United States
state: North Carolina
city: Charlotte
country: United States
state: North Carolina
city: Durham
country: United States
state: North Carolina
city: Hershey
country: United States
facility: Pennsylvania
state: Pennsylvania
city: Arlington
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: San Antonio
country: United States
state: Texas
city: Fairfax
country: United States
facility: Virginia
state: Virginia
city: Falls Church
country: United States
state: Virginia
city: Norfolk
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Seattle
country: United States
state: Washington
city: Madison
country: United States
state: Wisconsin
city: Madison
country: United States
state: Wisconsin
city: Milwaukee
country: United States
state: Wisconsin
city: Linz
country: Austria
city: Vienna
country: Austria
city: Vienna
country: Austria
city: Calgary
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Edmonton
country: Canada
state: Alberta
city: Vancouver
country: Canada
state: British Columbia
city: Winnipeg
country: Canada
state: Manitoba
city: Toronto
country: Canada
state: Ontario
city: Toronto
country: Canada
state: Ontario
city: Berlin
country: Germany
city: Dusseldorf
country: Germany
city: Frankfurt
country: Germany
city: Hamburg
country: Germany
city: Hannover
country: Germany
city: Koeln
country: Germany
city: Leipzig
country: Germany
city: Munich
country: Germany
city: Haifa
country: Israel
city: Haifa
country: Israel
city: Jerusalem
country: Israel
facility: Israel
city: Nazareth
country: Israel
city: Petah Tikva
country: Israel
city: Tel Hashomer
country: Israel
city: Bialystok
country: Poland
city: Czeladz
country: Poland
city: Myslowice
country: Poland
city: Wroclaw
country: Poland
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Mark Friedman, M.D.
role: STUDY_DIRECTOR
References: