Phase 3
Completed N=457
An Efficacy, Pharmacokinetics, Safety and Tolerability Study of TMC435 as Part of a Treatment Regimen for Hepatitis C-Infected Patients
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01725529 ↗
Enrolled (actual)
457
Serious AEs
4.2%
Results posted
Aug 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12) — 75.7; 88.9; 90.8 Percentage of participants
Summary
The purpose of this study is to provide confirmatory efficacy and safety data of TMC435 as part of a treatment regimen including peginterferon-alpha (PegIFNα-2a) and ribavirin (RBV) in patients with genotype 1 Hepatitis C virus (HCV) infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After End of Study Drug Treatment (SVR12) |
75.7; 88.9; 90.8 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks After End of Study Drug Treatment (SVR24) |
75.0; 88.9; 90.8 | — |
| SECONDARY Percentage of Participants With Sustained Virologic Response at Week 72 (SVRW72) |
75.0; 87.6; 90.1 | — |
| SECONDARY Percentage of Participants With On-treatment Failure |
12.5; 3.3; 3.3 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
2.0; 2.6; 2.6 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
11.5; 1.4; 2.8 | — |
| SECONDARY Percentage of Participants With On-treatment Normalization of Alanine Aminotransferase Level |
85.7; 86.1; 89.9 | — |
Eligibility Criteria
Inclusion Criteria
- A liver biopsy within 3 years prior to the screening visit (or between screening and day of randomization) with histology consistent with chronic Hepatitis C virus (HCV) infection
- Presence of contraindications for a liver biopsy in patients who are otherwise deemed eligible for participation does not exclude the patient from participation
- Genotype 1 HCV infection (confirmed at screening)
- Plasma HCV RNA of > 10, 000 IU/mL at screening
Exclusion Criteria
- Prior treatment with any approved or investigational drug for the treatment of hepatitis C
- Co-infection with hepatitis B virus or human immunodeficiency virus (HIV)
Data sourced from ClinicalTrials.gov (NCT01725529). 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.