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

Condition(s) targeted: Hepatitis C, Chronic

Intervention: Telaprevir (Drug); Peg-IFN-alfa-2a + Ribavirin (Standard Treatment) (Drug); Placebo (Drug)

Phase: Phase 2

Status: Completed

Sponsored by: Tibotec BVBA

Official(s) and/or principal investigator(s):
Tibotec-Virco Virology BVBA Clinical Trial, Study Director, Affiliation: Tibotec BVBA

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.

Official title: A Phase IIa Randomized, Partially Blinded Trial of Telaprevir (VX-950) in Treatment-Naive Subjects With Chronic Genotype 2 or 3 Hepatitis C Infection

Study design: Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Primary outcome:

Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Day 15

Maximum Plasma Concentration (Cmax) for Telaprevir on Day 1

Time to Reach Maximum Plasma Concentration (Tmax) for Telaprevir on Day 1

Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 1

Secondary outcome:

Area Under Plasma Concentration-Time Curve Over Dosing Interval (AUCtau) for Telaprevir on Day 15

Change From Baseline in Log 10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Level at Week 24 and Week 26

Maximum Plasma Concentration (Cmax) for Telaprevir on Day 15

Minimum Plasma Concentration (Cmin) for Telaprevir on Day 15

Percentage of Participants Achieving Virological Response (HCV RNA Level < 10 IU/ml)

Median Time to Virological Response (HCV RNA Level < 10 IU/ml)

Percentage of Participants With Viral Breakthrough

Percentage of Participants Who Demonstrated Virological Relapse

Percentage of Participants Who Achieved Sustained Virological Response (SVR)

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.

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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

Clichy, France

Creteil N/A, France

Lyon, France

Paris, France

Vandoeuvre Les Nancy, France

Stockholm, Sweden

London, United Kingdom

Starting date: December 2007
Last updated: June 7, 2013