Phase 2 Study of VX-950, Pegasys® With and Without Copegus® in Hepatitis C

NCT ID: NCT00372385

Last Updated: 2014-07-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 334 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2006-08-31
• Study Completion Date: 2008-06-30

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

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

PBO 12 Week+Peg-IFN-alfa-2a, RBV 48 Week

Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks.

Group Type: PLACEBO_COMPARATOR

Ribavirin

Intervention Type: DRUG

tablet

Pegylated Interferon Alfa 2a

Intervention Type: DRUG

Solution for injection

Placebo

Intervention Type: DRUG

tablet

Telaprevir 12 Week +Peg-IFN-alfa-2a,RBV 24 Week

Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks.

Group Type: EXPERIMENTAL

Ribavirin

Intervention Type: DRUG

tablet

Pegylated Interferon Alfa 2a

Intervention Type: DRUG

Solution for injection

Telaprevir

Intervention Type: DRUG

tablet

Telaprevir 12 Week+Peg-IFN-alfa-2a,RBV 12 Week

Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks.

Group Type: EXPERIMENTAL

Ribavirin

Intervention Type: DRUG

tablet

Pegylated Interferon Alfa 2a

Intervention Type: DRUG

Solution for injection

Telaprevir

Intervention Type: DRUG

tablet

Telaprevir 12 Week+Peg-IFN-alfa-2a 12 Week

Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.

Group Type: EXPERIMENTAL

Pegylated Interferon Alfa 2a

Intervention Type: DRUG

Solution for injection

Telaprevir

Intervention Type: DRUG

tablet

Interventions

Ribavirin

tablet

Intervention Type: DRUG

Pegylated Interferon Alfa 2a

Solution for injection

Intervention Type: DRUG

Placebo

tablet

Intervention Type: DRUG

Telaprevir

tablet

Intervention Type: DRUG

Other Intervention Names

VX-950

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).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vertex Pharmaceuticals Incorporated

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Monitor

Role: STUDY_DIRECTOR

Vertex Pharmaceuticals Incorporated

Locations

Call For Information

Call For Information, , Austria

Call For Information

Call For Information, , France

Call For Information

Call For Information, , Germany

Call for Information

Call For Information, , United Kingdom

Countries

Austria; France; Germany; United Kingdom

References

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.

Reference Type: DERIVED

PMID: 19403903 (View on PubMed)

Other Identifiers

VX05-950-104EU

Identifier Type: -

Identifier Source: org_study_id