Phase 3
Completed N=36
Open-Label, Bridging Study of Telaprevir in Treatment-Naïve and Treatment-Experienced Russian Patients With Genotype 1 Chronic Hepatitis C
Genotype 1 Chronic Hepatitis C
Source: ClinicalTrials.gov NCT01498068 ↗
Enrolled (actual)
36
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Number of Participants With Extended Rapid Virologic Response (eRVR) — 13; 18 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Extended Rapid Virologic Response (eRVR) |
13; 18 | — |
| SECONDARY Median Change in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) |
6.20; 6.10; -5.47; -5.33; -5.50; -5.39 | — |
| SECONDARY Number of Participants With Rapid Virologic Response (RVR) at Week 4 |
14; 18 | — |
| SECONDARY 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 |
16; 19; 15; 19; 15; 18 | — |
| SECONDARY Number of Participants With Virologic Failure |
1; 2 | — |
| SECONDARY Number of Participants in Each Specific Category of Treatment Outcome |
14; 16; 0; 1; 1; 2 | — |
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
Data sourced from ClinicalTrials.gov (NCT01498068). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.