A Phase 2a Study to Evaluate Viral Kinetics and Safety of Telaprevir in Participants With Genotype 2 or 3 Hepatitis C Infection

NCT ID: NCT00561015

Last Updated: 2013-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2009-05-31

Brief Summary

The purpose of this study is to assess the effect of telaprevir on early hepatitis (inflammation of the liver) C virus (HCV) viral kinetics in treatment-naive participants who are chronically (lasting a long time) infected with genotype 2 or 3 HCV.

Detailed Description

This is a Phase 2a multicenter (when more than one hospital or medical school team work on a medical research study), partially blinded, randomized (study drug assigned by chance) stratified (arrange in groups for analysis of results e.g., stratify by age, sex, etc.) for genotype, multiple dose study. The trial will consist of Screening period (6 weeks), Treatment period (24 or 26 weeks) and Follow-up period (24 weeks). The Treatment period will include 2 weeks investigational treatment phase and a 24 week standard treatment phase. All the eligible participants who were never treated for HCV will be enrolled for the trial and will receive the investigational treatment regimen to which they have been randomly assigned for 2 weeks. After this in the standard treatment phase participants will receive the standard treatment of care consisting of pegylated interferon (Peg-IFN)-alfa-2a 180 microgram once weekly and ribavirin (RBV) 400 milligram twice per day. Efficacy will primarily be evaluated by HCV viral load quantification. Participant's safety will be monitored throughout the study.

Conditions

Hepatitis C, Chronic

Study Design

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

Study Groups

TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 2

Participants who are never treated for chronic hepatitis C (inflammation of the liver) genotype 2 will receive telaprevir (TVR) 750 milligram (mg) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) from Day 15 to Week 26 (standard treatment phase). Each dose of pegylated interferon 180 microgram (mcg) will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 26 weeks.

Group Type: EXPERIMENTAL

Telaprevir

Intervention Type: DRUG

Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.

Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)

Intervention Type: DRUG

Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 \& PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.

TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 2

Participants who are never treated for CHC genotype 2 will receive TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.

Group Type: EXPERIMENTAL

Telaprevir

Intervention Type: DRUG

Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.

Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)

Intervention Type: DRUG

Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 \& PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.

Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 2

Participants who are never treated for CHC genotype 2 will receive TVR matching placebo (Pbo) tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.

Group Type: ACTIVE_COMPARATOR

Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)

Intervention Type: DRUG

Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 \& PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.

Placebo

Intervention Type: DRUG

Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.

TVR then Peg-IFN-alfa-2a + RBV (T2 & PR24) - Genotype 3

Participants who are never treated for CHC genotype 3 will receive TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15. Participants will then be treated with standard treatment regimen of Peg-IFN-alfa-2a and RBV from Day 15 to Week 26 (standard treatment phase). Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 26 weeks.

Group Type: EXPERIMENTAL

Telaprevir

Intervention Type: DRUG

Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.

Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)

Intervention Type: DRUG

Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 \& PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.

TVR with Peg-IFN-alfa-2a + RBV (T2/PR24) - Genotype 3

Participants who are never treated for CHC genotype 3 received TVR 750 mg tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.

Group Type: EXPERIMENTAL

Telaprevir

Intervention Type: DRUG

Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.

Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)

Intervention Type: DRUG

Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 \& PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.

Pbo with Peg-IFN-alfa-2a + RBV (Pbo/PR24) - Genotype 3

Participants who are never treated for CHC genotype 3 will receive TVR matching Pbo tablet orally 3 times a day during investigational treatment phase from Day 1 to Day 15 along with standard treatment regimen of Peg-IFN-alfa-2a and RBV which will be continued in the standard treatment phase from Day 15 to Week 24. Each dose of Peg-IFN-alfa-2a 180 mcg will be administered as a subcutaneous injection once a week. RBV will be taken orally as 400 mg tablets 2 times a day. Total duration of treatment will be 24 weeks.

Group Type: ACTIVE_COMPARATOR

Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)

Intervention Type: DRUG

Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 \& PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.

Placebo

Intervention Type: DRUG

Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.

Interventions

Telaprevir

Telaprevir 750 mg tablet will be administered three times a day orally for 2 weeks.

Intervention Type: DRUG

Peg-IFN-alfa-2a + Ribavirin (Standard Treatment)

Standard treatment of Peg-IFN-alfa-2a (180 mcg subcutaneous injection, once weekly) and ribavirin (400 mg as oral tablet twice daily) will be administered from Day 15 to Week 24 or 26 in the T2 \& PR24 - genotype 2 and 3 group and from Day 1 to Week 24 or 26 in the T2/PR24 - genotype 2 and 3 group.

Intervention Type: DRUG

Placebo

Matching placebo tablet to telaprevir will be administered three times a day orally for 2 weeks.

Intervention Type: DRUG

Other Intervention Names

VX-950

Eligibility Criteria

Inclusion Criteria

• Participants chronically infected with genotype 2 or 3 hepatitis C virus (HCV) with amount of virus in the blood greater than 10,000 international units per milliliter (IU/ml)
• Participants who were never treated for hepatitis C virus infection
• Participants without any significant lab abnormalities
• Participants who agree to the use of two effective methods of contraception
• Participant who were judged to be in good health

Exclusion Criteria

• Participants who had contraindications for starting anti-HCV therapy
• Participants who had history or evidence of liver cirrhosis (serious liver disorder in which connective tissue replaces normal liver tissue, and liver failure often occurs) or decompensated liver disease or hepatocellular carcinoma (type of cancer)
• Participant infected with human immunodeficiency virus (a life-threatening infection that you can get from an infected person's blood or from having sex with an infected person) or hepatitis B virus
• Females who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding
• Participants who have hypersensitivity to tartrazine

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

Sponsors

Tibotec BVBA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tibotec-Virco Virology BVBA Clinical Trial

Role: STUDY_DIRECTOR

Tibotec BVBA

Locations

Clichy, , France

Créteil, , France

Lyon, , France

Paris, , France

Vandœuvre-lès-Nancy, , France

Stockholm, , Sweden

London, , United Kingdom

Countries

France; Sweden; United Kingdom

Other Identifiers

VX-950-TiDP24-C209

Identifier Type: -

Identifier Source: secondary_id

CR013513

Identifier Type: -

Identifier Source: org_study_id

NCT00613704

Identifier Type: -

Identifier Source: nct_alias