Phase 2
Completed N=20
Open-Label Safety Study of Telaprevir and Sofosbuvir in Chronic Hepatitis C Genotype 1
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01994486 ↗
Enrolled (actual)
20
Serious AEs
5.0%
Results posted
Mar 2015
Primary outcomePrimary: Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir — 0 participants
Summary
This is an open-label, multi center study of treatment-naive non-cirrhotic subjects with genotype 1 chronic Hepatitis C Virus. All subjects will receive telaprevir (TVR) in combination with sofosbuvir (SOF) for 12 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of Adverse Events Leading to Discontinuation of Both Telaprevir and Sofosbuvir Among Subjects Treated With Telaprevir and Sofosbuvir |
— | — |
| PRIMARY Safety of Telaprevir and Sofosbuvir When Dosed in Combination for 12 Weeks |
1 | — |
| SECONDARY Characterize Steady State of Sofosbuvir Active SOF Metabolite, GS-331007 |
593; 619 | — |
| SECONDARY Proportion of Subjects Who Achieve Undetectable Hepatitis C Virus RNA at 12 Weeks After Completing Study Drug Regimen |
19 | — |
| SECONDARY Proportion of Subjects With Viral Relapse |
1 | — |
Eligibility Criteria
Inclusion Criteria
- Willing and able to provide informed consent
- BMI (Body Mass Index) ≥ 18 kg/m2
- HCV RNA quantifiable at screening and >1,000 IU/ml
- HCV treatment Naïve
- HCV genotype 1
- 7. Confirmation of chronic HCV infection documented by either: A positive anti-HCV antibody test or positive HCV RNA or positive HCV genotyping test at least 6 months prior to the Baseline/Day 1 visit, or A liver biopsy performed prior to the Baseline/Day 1 visit with evidence of chronic HCV infection
Exclusion Criteria
- Current or prior history of any of the following:
Clinically-significant illness Cirrhosis 2. Screening ECG with clinically significant abnormalities
- ALT > 10 x the upper limit of normal (ULN)
- AST > 10 x ULN
- Direct bilirubin > 1.5 x ULN
- Platelets 7.5%
- Creatinine clearance (CLcr) 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regimen affecting INR 4. Prior exposure to any approved or experimental HCV-specific direct-acting
- Pregnant or nursing female or male with pregnant female partner.
- Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis).
- Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV).
Data sourced from ClinicalTrials.gov (NCT01994486). 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.