Phase 3
Completed N=183
A Phase III Study of TMC435 in Treatment-naive, Genotype 1, Hepatitis C-infected Patients
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01292239 ↗
Enrolled (actual)
183
Serious AEs
5.5%
Results posted
Dec 2013
Primary outcomePrimary: The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12) — 88.6; 61.7 Percentage of participants — p=<0.0001
Summary
The purpose of this study is to evaluate the efficacy and safety of TMC435 compared with placebo in combination with peginterferon alfa-2a (pegIFN alfa-2a) and ribavirin in treatment-naive patients with chronic genotype 1 hepatitis C virus (HCV) infection in Japan.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 12 Weeks After the Last Dose of Treatment (SVR12) |
88.6; 61.7 | <0.0001 sig |
| SECONDARY The Percentage of Participants With a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the Last Dose of Treatment (SVR24) |
88.6; 56.7 | <0.0001 sig |
| SECONDARY The Percentage of Participants Who Achieved a Greater Than or Equal to 2 log10 IU/mL Drop From Baseline in Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) at Each Time Point During Treatment and Follow-up |
98.4; 26.7; 99.2; 46.7; 100.0; 58.3 | — |
| SECONDARY The Percentage of Participants With Undetectable Plasma Levels of Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT) |
83.7; 13.3; 96.7; 63.3; 91.9; 73.3 | — |
| SECONDARY The Number of Participants With Viral Breakthrough |
1; 2 | — |
| SECONDARY The Number of Participants Demonstrating Viral Relapse |
9; 15 | — |
| SECONDARY The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT) |
47; 18 | — |
| SECONDARY The Percentage of Participants in the TMC435 Treatment Group Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2a (PegIFN Alpha-2a) and Ribavirin (RBV) at Week 24 |
91.9 | — |
| SECONDARY Plasma Concentrations of TMC435 |
1005; 2601 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435 |
42721 | — |
Eligibility Criteria
Inclusion Criteria
- Patient must have chronic genotype 1 HCV infection with HCV RNA level >= 5.0 log10 IU/mL
- Patient has never received treatment for HCV
- Patient must be willing to use contraceptive measures from the time of informed consent to 6 months after last dose of study medication
Exclusion Criteria
- Co-infection with any other HCV genotype or co-infection with the human immunodeficiency virus (HIV)
- Diagnosed with hepatic cirrhosis or hepatic failure
- A medical condition which is a contraindication to pegIFN or ribavirin therapy
- History of, or any current medical condition which could impact the safety of the patient in the study
Data sourced from ClinicalTrials.gov (NCT01292239). 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.