Phase 3
N=79
A Study of TMC435 in Participants With Genotype 1 Hepatitis C Virus (HCV) Infection
Hepatitis C, Chronic
Bottom Line
View on ClinicalTrials.gov: NCT01366638 ↗Enrolled (actual)
79
Serious AEs
2.5%
Results posted
Jan 2014
Primary outcome: Primary: The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12) — 91.7; 100.0; 38.5 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- TMC435 (Drug); Peginterferon alfa-2b (pegIFN alfa-2b) (Drug); Ribavirin (RBV) (Drug)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Janssen Pharmaceutical K.K.
- Primary completion
- Nov 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12) |
91.7; 100.0; 38.5 | — |
| PRIMARY The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24) |
91.7; 96.6; 38.5 | — |
| PRIMARY The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During Treatment and at the End of Treatment |
79.2; 86.2; 57.7; 100; 100; 76.9 | — |
| PRIMARY The Number of Participants With Viral Breakthrough |
0; 0; 2 | — |
| PRIMARY The Number of Participants Demonstrating Viral Relapse |
2; 1; 4 | — |
| PRIMARY The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal Limit of ALT at the End of Treatment (EOT) |
13; 8; 8 | — |
| PRIMARY 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 |
100; 100; 88.5; 100; 100; 100 | — |
| PRIMARY The Percentage of Participants Who Met Response Guided Treatment (RGT) Criteria and Completed Treatment With Peginterferon Alpha-2b (PegIFNα-2b) and Ribavirin (RBV) at Week 24 |
91.7; 96.6 | — |
| PRIMARY The Area Under the Plasma Concentration-Time Curve (From 0 to 24 Hours) (AUC24h) |
35448; 68130; 40645 | — |
| PRIMARY Plasma Concentrations of TMC435 |
2304; 3643; 2521; 735; 2015; 921 | — |
Summary
The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2b and ribavirin in chronic genotype 1 hepatitis C virus (HCV)-infected participants who are treatment-naive or treatment-experienced (prior relapser or non-responder to Interferon-based therapy) in Japan.
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 (treatment-naive), relapsed after previous IFN-based therapy (prior relapser) or failed to respond to previous IFN-based therapy (non-responder)
- 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 peg-IFN 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 (NCT01366638). 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.