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

Tibotec Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Chronic Hepatitis C

Treatments: Drug: Telaprevir; Drug: Ribavirin (RBV) tablet; Drug: Peg-IFN-alfa-2b; Drug: Peg-IFN-alfa-2a; Drug: Ribavirin (RBV) capsule

Study type: Interventional

Funder types: Industry

Identifiers

NCT00528528

CR013516

VX-950-TIDP24-C208

2007-001044-44 (EudraCT Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 166 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 4 patient groups

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

Experimental group

Description:

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.

Treatment:

Drug: Ribavirin (RBV) tablet

Drug: Telaprevir

Drug: Peg-IFN-alfa-2a

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

Experimental group

Description:

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.

Treatment:

Drug: Ribavirin (RBV) capsule

Drug: Telaprevir

Drug: Peg-IFN-alfa-2b

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

Experimental group

Description:

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.

Treatment:

Drug: Ribavirin (RBV) tablet

Drug: Telaprevir

Drug: Peg-IFN-alfa-2a

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

Experimental group

Description:

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.

Treatment:

Drug: Ribavirin (RBV) capsule

Drug: Telaprevir

Drug: Peg-IFN-alfa-2b