Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C

Janssen (J&J Innovative Medicine)

Status and phase: Completed; Phase 3

Conditions: Genotype 1 Chronic Hepatitis C

Treatments: Drug: Pegylated-interferon-alfa-2a; Drug: Ribavirin; Drug: Telaprevir

Study type: Interventional

Funder types: Industry

Identifiers

NCT01498068

VX-950HPC3007 (Other Identifier)

CR100676

Details and patient eligibility

About

The purpose of this study is to determine the effectiveness, safety and tolerability of telaprevir administered as 750 mg every 8 hours (q8h) in combination with pegylated interferon (Peg-IFN)-alfa-2a and ribavirin (RBV) in treatment-naïve and treatment-experienced Russian participants with genotype 1 chronic hepatitis C.

Full description

This is an open-label (all persons know the study drug assignment), multicenter study in treatment-naïve (participant did not receive any previous treatment for the treatment of hepatitis C) and treatment-experienced (participant did receive previous treatment for hepatitis C) Russian participants with genotype 1 chronic hepatitis C. After a screening period of approximately 4 weeks, participants will be treated for 12 weeks with telaprevir 750 mg every 8 hours in combination with Peg-IFN-alfa-2a and RBV followed by 12 or 36 weeks of treatment with Peg-IFN-alfa-2a and RBV alone depending on their liver disease status, response to previous treatment and individual virologic response during treatment in this study. After the treatment period, there is a follow-up phase of at least 12 weeks.

Enrollment: 36 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participant has genotype 1 chronic hepatitis C with HCV RNA level >1000 IU/mL
• Participant is either treatment-naïve and did not receive any previous treatment with any approved or investigational drug or drug regimen for the treatment of hepatitis C, or participant is treatment-experienced who did not achieve sustained virologic response (SVR) 24 weeks after at least 1 prior course of Peg-IFN/RBV therapy (null-responder, partial-responder or viral relapse)
• Participant must have documentation of liver biopsy or fibroscan within 2 years before the screening visit or agree to have a biopsy or fibroscan within the screening period unless histological cirrhosis was demonstrated by a biopsy or fibroscan > 2 years ago prior to screening
• A female participant of childbearing potential and a nonvasectomized male participant who has a female partner of childbearing potential must agree to the use of 2 effective methods of birth control from screening until 6 months (female participant ) or 7 months (male participant) after the last dose of RBV

Exclusion criteria

• Prior non-responder that is classified as a viral breakthrough participant
• Participant is infected or co-infected with HCV of another genotype than genotype 1
• Participant has history of decompensated liver disease or shows evidence of significant liver disease in addition to hepatitis C
• Participant has human immunodeficiency virus (HIV) or hepatitis B virus (HBV) co-infection
• Participant has active malignant disease or history of malignant disease within the past 5 years (with the exception of treated basal cell carcinoma or hepatocellular carcinoma

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Treatment-naïve

Experimental group

Description:

Treatment naïve participants will receive telaprevir 750 mg 8 hourly for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram weekly and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration will be based on participant's prior treatment status, liver disease status, and individual ontreatment virologic response in this study.

Treatment:

Drug: Ribavirin

Drug: Pegylated-interferon-alfa-2a

Drug: Telaprevir

Treatment-experienced

Experimental group

Description:

Treatment-experienced participants received telaprevir 750 mg 8 hourly for 12 weeks in combination with Peg-IFN alfa-2a 180 microgram weekly and RBV 1000 - 1200 mg daily (dependent on weight) for 24 or 48 weeks. Total treatment duration will be based on participant's prior treatment status, liver disease status, and individual on-treatment virologic response in this study.

Treatment:

Drug: Ribavirin

Drug: Pegylated-interferon-alfa-2a

Drug: Telaprevir