Phase 2
Completed N=92
A Study to Assess the Effectiveness, Safety, and Pharmacokinetics of TMC435 in Combination With Peginterferon Alfa-2a and Ribavirin in Hepatitis-C Infected Patients
Hepatitis C, Chronic
Source: ClinicalTrials.gov NCT00996476 ↗
Enrolled (actual)
92
Serious AEs
5.4%
Results posted
Apr 2014
Primary outcomePrimary: Change in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels From Baseline to Week 4 — -5.23; -5.24; -2.83 log10 IU/mL
Summary
The purpose of this study is to evaluate effectiveness, safety and pharmacokinetics (Explores what the body does to the medication) of TMC435350 in combination with Peginterferon Alfa-2a and Ribavirin in genotype 1 hepatitis C virus infected Japanese participants who have never received treatment for their hepatitis C infection.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels From Baseline to Week 4 |
-5.23; -5.24; -2.83 | — |
| PRIMARY The Percentage of Participants With Undetectable Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels During the Study |
85.2; 100.0; 83.3; 92.3; 9.1; 100.00 | — |
| PRIMARY The Percentage of Participants With a Decrease of Greater Than or Equal to 2 log10 IU/mL From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Through the Post-treatment Follow-up Period |
NA; NA; NA; NA; NA; NA | — |
| PRIMARY The Percentage of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Undetectable or Below the Limit of Quantification (<1.2 log10 IU/mL Detectable) During Treatment and During Post Treatment Follow-up |
100.0; 100.0; 100.0; 100.0; 18.2; 100.0 | — |
| PRIMARY The Number of Participants With Viral Breakthrough |
0; 0; 0; 0; 0 | — |
| PRIMARY The Percentage of Participants With Viral Relapse |
15.4; 12.5; 16.7; 7.7; 40.0 | — |
| PRIMARY Actual Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Values up to Week 24 in the Post-treatment Follow-up Period |
6.19; 6.16; 6.16; 6.43; 6.10; 0.98 | — |
| PRIMARY The Number of Participants With Alanine Aminotransaminase (ALT) Values Within the Normal Range at the End-of-treatment (EOT) |
15; 15; 7; 7; 44; 7 | — |
| PRIMARY The Percentage of Participants With Sustained Virologic Response (SVR) |
88.9; 95.8; 92.3; 92.3; 63.6; 85.2 | — |
| PRIMARY Predose Plasma Concentrations (C0h) of TMC435 (Sparse Blood Sampling) |
238; 1229; 194; 1816; 261; 1483 | — |
| PRIMARY Predose Plasma Concentrations (C0h) of TMC435 (Intensive Blood Sampling) |
192; 1732 | — |
| PRIMARY The Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24) for TMC435 |
11182; 60197 | — |
| PRIMARY Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435 |
5.97; 6.00 | — |
| PRIMARY The Number of Participants Who Met Virologic Stopping/Continuation Rules and Completed All Study Medications |
25; 22; 10; 12; 0 | — |
Eligibility Criteria
Inclusion Criteria
- Participants with documented chronic hepatitis C infection as evidenced by presence of HCV antibody at least 6 months (180 days) prior to the informed consent. - Participants with genotype 1 HCV infection. - Participants with plasma HCV RNA level of ≥ 5.0 log10 IU/mL at screening.
Exclusion Criteria
- Participants diagnosed with hepatic cirrhosis or hepatic failure. - Participants with any other liver disease than hepatitis C. - Participants with infection/co-infection with non-genotype 1 HCV.
Data sourced from ClinicalTrials.gov (NCT00996476). 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.