An Open-Label Study of Telaprevir Administered Every 12 or 8 Hours in Combination With One of Two Pegylated Interferons and Ribavirin in Treatment-Naive Genotype 1 Chronic Hepatitis C Participants

NCT ID: NCT00528528

Last Updated: 2014-06-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 166 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2009-08-31

Brief Summary

The purpose of this study is to explore the efficacy, safety, tolerability, pharmacokinetics (the study of the way a drug enters and leaves the blood and tissues over time), and pharmacokinetic-pharmacodynamic relationships of telaprevir administered in two different doses in combination with two standard therapies commercially available for chronic (lasting a long time) genotype 1 Hepatitis (inflammation of the liver) C virus (HCV) infection.

Detailed Description

This is a Phase 2a, open-label (all people know the identity of the intervention), multicenter trial (conducted in more than one center) in participants with chronic genotype 1 HCV infection. The trial consists of a Screening phase of approximately 4 weeks, a treatment phase up to 48 weeks depending on participants' individual virologic response, and a follow-up phase of at least 24 weeks. All participants will receive 12 weeks of telaprevir treatment in combination with standard therapy. At Week 12, telaprevir dosing will end and participants will continue on standard therapy only. Participants will be randomly assigned to receive one of the two different dosage regimens of telaprevir (750 milligram [mg] every 8 hours (hr), or 1125 mg every 12 hr) in combination with standard therapy (pegylated interferon [Peg-IFN]-alfa-2a and ribavirin [RBV] or Peg-IFN-alfa-2b and RBV at the standard doses). Efficacy will be evaluated by HCV Ribonucleic Acid (RNA) values, viral response, viral breakthrough, partial response, early viral kinetics and sustained viral response. Pharmacokinetics, Pharmacokinetic-pharmacodynamic relationship will also be evaluated. Safety will be monitored throughout the study duration.

Conditions

Chronic Hepatitis C

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Telaprevir 750 mg with Peg-IFN-alfa-2a/RBV tablet

Telaprevir tablets at the dose of 750 milligram (mg) orally administered every 8 hours (hr) for 12 weeks, in combination with standard treatment composed of pegylated interferon (Peg-IFN)-alfa-2a solution for subcutaneous injection at the dose of 180 microgram per week (mcg/week) and ribavirin (RBV) oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.

Group Type: EXPERIMENTAL

Telaprevir

Intervention Type: DRUG

Oval tablets containing 375 mg of telaprevir for oral administration.

Peg-IFN-alfa-2a

Intervention Type: DRUG

Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.

Ribavirin (RBV) tablet

Intervention Type: DRUG

Tablets containing 200 mg RBV for oral administration.

Telaprevir 750 mg with Peg-IFN-alfa-2b/RBV capsule

Telaprevir tablets at the dose of 750 mg orally administered every 8 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kilogram/week (mcg/kg/week) and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.

Group Type: EXPERIMENTAL

Telaprevir

Intervention Type: DRUG

Oval tablets containing 375 mg of telaprevir for oral administration.

Peg-IFN-alfa-2b

Intervention Type: DRUG

Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.

Ribavirin (RBV) capsule

Intervention Type: DRUG

Capsules containing 200 mg RBV for oral administration.

Telaprevir 1125 mg with Peg-IFN-alfa-2a/RBV tablet

Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2a solution for subcutaneous injection at the dose of 180 mcg/week and RBV oral tablets at the dose of 1000-1200 mg/day up to 48 weeks.

Group Type: EXPERIMENTAL

Telaprevir

Intervention Type: DRUG

Oval tablets containing 375 mg of telaprevir for oral administration.

Peg-IFN-alfa-2a

Intervention Type: DRUG

Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.

Ribavirin (RBV) tablet

Intervention Type: DRUG

Tablets containing 200 mg RBV for oral administration.

Telaprevir 1125 mg with Peg-IFN-alfa-2b/RBV capsule

Telaprevir tablets at the dose of 1125 mg orally administered every 12 hr for 12 weeks, in combination with standard treatment composed of Peg-IFN-alfa-2b solution for subcutaneous injection at the dose of 1.5 mcg/kg/week and RBV oral capsules at the dose of 800-1200 mg/day up to 48 weeks.

Group Type: EXPERIMENTAL

Telaprevir

Intervention Type: DRUG

Oval tablets containing 375 mg of telaprevir for oral administration.

Peg-IFN-alfa-2b

Intervention Type: DRUG

Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.

Ribavirin (RBV) capsule

Intervention Type: DRUG

Capsules containing 200 mg RBV for oral administration.

Interventions

Telaprevir

Oval tablets containing 375 mg of telaprevir for oral administration.

Intervention Type: DRUG

Peg-IFN-alfa-2a

Solution containing Peg-IFN alfa2a for subcutaneous injection in a pre-filled syringe.

Intervention Type: DRUG

Peg-IFN-alfa-2b

Powder containing Peg-IFN-alfa-2b and solvent for solution for subcutaneous injection in a pre-filled pen.

Intervention Type: DRUG

Ribavirin (RBV) tablet

Tablets containing 200 mg RBV for oral administration.

Intervention Type: DRUG

Ribavirin (RBV) capsule

Capsules containing 200 mg RBV for oral administration.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Chronic genotype 1 Hepatitis (inflammation of the liver) C infection
• Never been treated for Hepatitis C Viral (HCV) infection
• No clinically significant lab abnormalities
• Amount of HCV Ribonucleic acid (RNA) in the blood more than 10,000 international units/milliliter (IU/mL) at entry
• Liver biopsy or "Fibroscan" test performed during screening or in the past 3 years

Exclusion Criteria

• Contra-indications for starting anti-HCV therapy
• 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
• Any evidence of significant liver disease in addition to Hepatitis C
• Infected with Human Immunodeficiency Virus (a life-threatening infection which you can get from an infected person's blood or from having sex with an infected person) or Hepatitis B
• Women who are pregnant (carrying an unborn baby), planning to be pregnant or breastfeeding or the partner of a woman who is pregnant or breastfeeding

• 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

Vienna, , Austria

Brussels, , Belgium

Ghent, , Belgium

Leuven, , Belgium

Liège, , Belgium

Angers, , France

Clichy, , France

Grenoble, , France

Lille, , France

Nice, , France

Paris, , France

Vandœuvre-lès-Nancy, , France

Cologne, , Germany

Düsseldorf, , Germany

Frankfurt, , Germany

Freiburg im Breisgau, , Germany

Hamburg, , Germany

Hanover, , Germany

Tübingen, , Germany

Leiden, , Netherlands

Nijmegen, , Netherlands

Barcelona, , Spain

Madrid, , Spain

Valencia, , Spain

Countries

Austria; Belgium; France; Germany; Netherlands; Spain

References

Serfaty L, Forns X, Goeser T, Ferenci P, Nevens F, Carosi G, Drenth JP, Lonjon-Domanec I, DeMasi R, Picchio G, Beumont M, Marcellin P. Insulin resistance and response to telaprevir plus peginterferon alpha and ribavirin in treatment-naive patients infected with HCV genotype 1. Gut. 2012 Oct;61(10):1473-80. doi: 10.1136/gutjnl-2011-300749. Epub 2012 Mar 2.

Reference Type: DERIVED

PMID: 22387529 (View on PubMed)

Other Identifiers

VX-950-TIDP24-C208

Identifier Type: -

Identifier Source: secondary_id

2007-001044-44

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CR013516

Identifier Type: -

Identifier Source: org_study_id

NCT00614497

Identifier Type: -

Identifier Source: nct_alias