Clinical trial NCT00372385: Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C
Official title: A Phase 2 Study of VX-950 in Combination With Peginterferon Alfa-2a (Pegasys®), With and Without Ribavirin (Copegus®) in Subjects With Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2006-09-06
Enrollment: 334
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels


Eligibility criteria: Inclusion Criteria:

* Hepatitis C virus Genotype 1 with detectable plasma hepatitis C virus RNA
* Have been infected with Hepatitis C virus for greater than (\>) 6 months
* Seronegative for hepatitis B surface antigen and human immunodeficiency virus 1 and 2
* Must agree to use 2 methods of contraception, including 1 barrier method, during and for 24 weeks after the completion of the study (unless the subject is a female of documented non-child-bearing potential)
* Female subjects must have a negative pregnancy test at all visits before the first dose.

Exclusion Criteria:

* Received any approved or investigational drug or drug regimen for the treatment of hepatitis C.
* Any medical contraindications to Peg-IFN-alfa-2a or Ribavirin therapy
* Any other cause of significant liver disease in addition to hepatitis C; this may include but is not limited to, hepatitis B, drug or alcohol-related cirrhosis, autoimmune hepatitis, hemochromatosis, Wilson's disease, Nonalcoholic Steatohepatitis or primary biliary cirrhosis.
* Diagnosed or suspected hepatocellular carcinoma.
* Histologic evidence of hepatic cirrhosis (including compensated cirrhosis) based on a liver biopsy taken within 2 years before Study start.
* Alcohol/drug abuse or excessive use in the last 12 months.
* Participation in any investigational drug study within 90 days before drug administration or participation in more than 2 drug studies in the last 12 months (exclusive of the current study).

Primary outcomes:
measure: Percentage of Subjects With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) at Week 24 After the Completion of Study Drug Dosing
timeFrame: 24 weeks after the completion of study drug dosing (up to Week 72)
Secondary outcomes:
measure: Percentage of Subjects With Undetectable Plasma HCV RNA at Week 12 After the Completion of Study Drug Dosing
timeFrame: 12 weeks after the completion of study drug dosing (up to Week 60)
measure: Percentage of Subjects With Undetectable Plasma HCV RNA at Completion of Study Drug Dosing
timeFrame: Completion of study drug dosing (up to Week 48)
measure: Number of Subjects With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to Week 48
measure: Number of Subjects With Viral Relapse
timeFrame: After last dose of study drug up to antiviral follow-up (up to Week 72)
measure: Maximum (Cmax), Minimum (Cmin) and Average (Cavg) Plasma Concentration of Telaprevir
timeFrame: Day 1, 4, 8, 15, 22, 29, 43, 57, 71, 85
Other outcomes:
Locations:
city: Call For Information
country: Austria
facility: Call For Information
city: Call For Information
country: France
facility: Call For Information
city: Call For Information
country: Germany
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country: United Kingdom
facility: Call for Information
Study officials:
affiliation: Vertex Pharmaceuticals Incorporated
name: Medical Monitor
role: STUDY_DIRECTOR
References:
citation: Hezode C, Forestier N, Dusheiko G, Ferenci P, Pol S, Goeser T, Bronowicki JP, Bourliere M, Gharakhanian S, Bengtsson L, McNair L, George S, Kieffer T, Kwong A, Kauffman RS, Alam J, Pawlotsky JM, Zeuzem S; PROVE2 Study Team. Telaprevir and peginterferon with or without ribavirin for chronic HCV infection. N Engl J Med. 2009 Apr 30;360(18):1839-50. doi: 10.1056/NEJMoa0807650.