Status:
COMPLETED
Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
Lead Sponsor:
Janssen-Cilag International NV
Conditions:
Genotype 1 Chronic Hepatitis C
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
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...
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2013
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01498068
Start Date
January 1 2012
End Date
March 1 2013
Last Update
January 30 2015
Active Locations (5)
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1
Moscow, Russia
2
Saint Petersburg, Russia
3
Samara, Russia
4
Smolensk, Russia