Phase 3
Completed N=49
A Study of TMC435 in Genotype 1, Hepatitis C-infected Patients Who Relapsed After Previous Interferon (IFN)-Based Therapy
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT01290731 ↗
Enrolled (actual)
49
Serious AEs
12.2%
Results posted
Feb 2014
Primary outcomePrimary: The Percentage of Participants With a Sustained Virologic Response 12 Weeks After the Actual End of Treatment (SVR12) — 95.9 Percentage of participants
Summary
The purpose of this study is to evaluate the efficacy and safety of TMC435 in combination with peginterferon alfa-2a (PegIFNα-2a) and ribavirin in genotype 1 hepatitis C virus (HCV)-infected participants who relapsed after previous interferon (IFN)-based therapy in Japan.
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) |
95.9 | — |
| SECONDARY The Percentage of Participants With a Sustained Virologic Response 24 Weeks After the Actual End of Treatment (SVR24) |
89.8 | — |
| 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 |
93.9; 100.0; 100.0; 98.0; 100.0; 100.0 | — |
| SECONDARY The Percentage of Participants With Undetectable Plasma Hepatitis C Virus Ribonucleic Acid (HCV RNA) During Treatment and at the End of Treatment (EOT) |
81.6; 100.0; 95.9; 91.8; 89.8; 89.8 | — |
| SECONDARY The Number of Participants With Viral Breakthrough |
— | — |
| SECONDARY The Number of Participants Demonstrating Viral Relapse |
4 | — |
| SECONDARY Plasma Concentrations of TMC435 |
1822; 3440 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 to 24 Hrs (AUC24h) for TMC435 |
63261 | — |
| SECONDARY The Number of Participants With Abnormal Alanine Aminotransferase (ALT) Levels at Baseline Who Achieved Normal ALT Levels at the End of Treatment (EOT) |
11 | — |
Eligibility Criteria
Inclusion Criteria
- Participants must have chronic genotype 1 HCV with HCV RNA level >= 5.0 log10 IU/mL
- Participant relapsed after previous IFN-based therapy
- Participant 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 (NCT01290731). 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.