Phase 3
Completed N=771
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy
Source: ClinicalTrials.gov NCT01485991 ↗Enrolled (actual)
771
Serious AEs
10.0%
Results posted
Apr 2015
Primary outcomePrimary: Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) — 53.6; 54.7 percentage of participants — p=0.001
Summary
The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) |
53.6; 54.7 | 0.001 sig |
| SECONDARY Percentage of Participants With Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24) |
53.3; 55.2 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
17.9; 16.4 | — |
Eligibility Criteria
Inclusion Criteria
- Patient must have had a liver biopsy before screening (or between the screening and baseline visit), unless patient cannot undergo such a procedure or has evidence of portal hypertension not associated with cirrhosis. For patients who had a liver biopsy performed more than 2 years prior to screening or without a biopsy (because of a contraindication or portal hypertension), a non-invasive staging assessment needs to be available. Non-invasive staging assessments include FibroScan, MR-Elastography, or FibroTest/FibroSure and must not be older than 6 months prior to screening
- Chronicity of hepatitis C virus (HCV) infection, as confirmed by one or both of the following: presence of anti-HCV antibody and/or HCV ribonucleic acid (RNA) at least 6 months prior to the screening visit and/or presence of fibrosis on biopsy
- Genotype 1 HCV infection with plasma HCV RNA of >10,000 IU/mL (both confirmed at screening)
- Patient must have had at least 1 documented previous course of treatment with PegINFα-2a or PegINFα-2b in combination with ribavirin (RBV) (at least 12 weeks for null responder and 20 weeks for partial responder)
Exclusion Criteria
- Hepatic decompensation (impaired functioning of the liver), as indicated by significant laboratory abnormalities or other active diseases
- Infection with Human Immunodeficiency Virus (HIV) or non genotype 1 hepatitis C
- Liver disease not related to hepatitis C infection
- Previous chronic hepatitis C treatment, other than PegIFN and RBV
Data sourced from ClinicalTrials.gov (NCT01485991). 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.