Clinical trial NCT01498068: Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
Official title: Open-Label, Bridging Study to Determine Efficacy and Safety of Telaprevir, Pegylated-Interferon-alfa-2a and Ribavirin in Treatment- Naïve and Treatment-Experienced Russian Subjects With Genotype 1 Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Genotype 1 Chronic Hepatitis C
Keywords: Genotype 1 chronic Hepatitis C
VX-950HPC3007
VX-950
Hepatitis C
Telaprevir
HCV
Lead sponsor: Janssen-Cilag International NV
Sponsor class: INDUSTRY
First posted: 2011-12-23
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Extended Rapid Virologic Response (eRVR)
timeFrame: Week 4 and Week 12
Secondary outcomes:
measure: Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA)
timeFrame: Baseline (Week 0), Week 4, Week 8, Week 12, Week 24, Week 32, Week 40, and Week 48
measure: Number of Participants With Rapid Virologic Response (RVR) at Week 4
timeFrame: Week 4
measure: Number of Participants With Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Less Than 25 IU/mL, (Target Not Detected) at Weeks 8, 12, 24, 32, 40 and 48
timeFrame: Weeks 8, 12, 24, 32, 40 and 48
measure: Number of Participants With Virologic Failure
timeFrame: Week 4, Week 8, Week 12, Week 24, Week 32, or Week 40
measure: Number of Participants in Each Specific Category of Treatment Outcome
timeFrame: From Day 1 (Baseline) up to Follow-up visit (Week 36 or Week 60)
Other outcomes:
Locations:
city: Moscow
country: Russian Federation
city: Saint-Petersburg
country: Russian Federation
city: Samara
country: Russian Federation
city: Smolensk
country: Russian Federation
city: Stavropol
country: Russian Federation
Study officials:
affiliation: Janssen-Cilag International NV
name: Janssen-Cilag International NV, Belgium Clinical Trial
role: STUDY_DIRECTOR
References: