Phase 3
Completed N=311
A Study to Evaluate the Efficacy and Safety of Three Experimental Drugs Compared With Telaprevir (a Licensed Product) in People With Hepatitis C Virus Infection Who Have Not Had Treatment Before
Chronic Hepatitis C Infection
Source: ClinicalTrials.gov NCT01854697 ↗
Enrolled (actual)
311
Serious AEs
3.2%
Results posted
Feb 2016
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses — 97.1; 82.4; 98.8; 97.6 percentage of participants
Summary
This is a study to evaluate the efficacy and safety of three experimental drugs compared with telaprevir (a licensed product) in people with hepatitis C virus infection who have not had treatment before.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After Treatment (SVR12) - Primary Efficacy Analyses |
97.1; 82.4; 98.8; 97.6; 78.0 | — |
| SECONDARY Mean Change From Baseline to the Final Treatment Visit in Short-Form 36 Version 2 Health Status Survey (SF-36V2) Mental Component Summary (MCS) |
-4.2; -5.8; -0.3; -0.1; -6.4 | 0.351 |
| SECONDARY Mean Change From Baseline to the Final Treatment Visit in SF-36V2 Physical Component Summary (PCS) |
0.5; -5.5; 0.4; 2.2; -5.5 | <0.001 sig |
| SECONDARY Percentage of Participants With SVR12 - Secondary Efficacy Analyses |
97.1; 82.4; 98.8; 97.6; 78.0 | 0.021 sig |
| SECONDARY Percentage of Participants With Virologic Failure During Treatment |
2.9; 5.9; 0; 1.2; 12.2 | — |
| SECONDARY Percentage of Participants With Post-treatment Relapse |
0; 0; 1.2; 0; 6.3 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks After Treatment (SVR24) |
95.7; 82.4; 97.6; 97.6; 78.0 | — |
Eligibility Criteria
Inclusion Criteria
- Males or females between 18 and 65 years, inclusive, at time of Screening
- Females must be post-menopausal for more than 2 years or surgically sterile or practicing abstinence/specific forms of birth control
- Subject has never received antiviral treatment for hepatitis C infection
- Chronic HCV Genotype-1 infection prior to study enrollment
Exclusion Criteria
- Positive test result for Hepatitis B surface antigen (HBsAg) or anti-Human Immunodeficiency virus antibody (HIV Ab)
- Females who are pregnant or plan to become pregnant, or breastfeeding
- Any current or past clinical evidence of cirrhosis
- Screening laboratory analyses that showing abnormal laboratory results
- Use of contraindicated medications within 2 weeks of dosing and subject with contraindication for telaprevir, pegIFN and RBV
- Recent (within 6 months prior to study drug administration) history of drug or alcohol abuse that could preclude adherence to the protocol
- Positive screen for drugs or alcohol
Data sourced from ClinicalTrials.gov (NCT01854697). 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.