Phase 2
Completed N=462
A Safety and Effectiveness Study of TMC435 in Chronic, Genotype 1, Hepatitis C Patients Who Failed to Previous Standard Treatment
Source: ClinicalTrials.gov NCT00980330 ↗Enrolled (actual)
462
Serious AEs
7.6%
Results posted
Feb 2014
Primary outcomePrimary: The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24) — 69.7; 66.2; 60.6; 66.7 Percentage of participants
Summary
The purpose of this study is to determine the efficacy, safety and tolerability of different regimens of TMC435 with standard treatment compared to standard treatment alone in participants with chronic, genotype 1, hepatitis C virus (HCV) infection who has failed previous treatment with pegylated interferon (Peg-INF-alfa-2a) and ribavirin (RBV).
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Achieving a Sustained Virologic Response at the End of Treatment (EOT) and 24 Weeks After the EOT (SVR24) |
69.7; 66.2; 60.6; 66.7; 72.1; 80.0 | — |
| SECONDARY The Percentage of Participants With a Greater Than 2 log10 Drop in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels at Time Points During Treatment |
97.0; 93.8; 97.0; 100.0; 95.6; 96.9 | — |
| SECONDARY The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable During Treatment and Follow-up |
22.7; 18.5; 15.2; 24.2; 32.4; 27.7 | — |
| SECONDARY The Percentage of Participants Achieving Plasma Levels of Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Detectable or Undetectable During Treatment and Follow-up |
60.6; 55.4; 54.5; 63.6; 60.3; 66.2 | — |
| SECONDARY The Percentage of Participants Achieving a Rapid Virologic Response (RVR) |
66.7; 58.5; 53.0; 62.1; 67.6; 66.2 | — |
| SECONDARY The Percentage of Participants Achieving an Early Virologic Response (EVR) |
90.9; 87.7; 84.8; 92.4; 91.2; 92.3 | — |
| SECONDARY The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR) |
81.8; 73.8; 72.7; 80.3; 85.3; 83.1 | — |
| SECONDARY The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) |
69.7; 67.7; 60.6; 66.7; 72.1; 80.0 | — |
| SECONDARY The Percentage of Participants With Viral Breakthrough |
10.6; 13.8; 13.6; 9.1; 10.3; 7.7 | — |
| SECONDARY The Percentage of Participants With Viral Relapse |
9.3; 13.7; 18.0; 11.8; 14.0; 5.5 | — |
| SECONDARY The Number of Participants Who Achieved Normalized Alanine Aminotransferase (ALT) Levels at the End of Treatment (EOT) |
26; 37; 31; 23; 31; 33 | — |
| SECONDARY Plasma Concentrations of TMC435 |
380.5; 411.3; 529.8; 1323.5; 1074.0; 886.1 | — |
| SECONDARY Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC24h) for TMC435 |
16587.0; 18492.5; 21409.0; 47061.8; 43015.0; 38564.5 | — |
Eligibility Criteria
Inclusion Criteria
- Must have chronic hepatitis C infection as evidenced by liver biopsy, anti-hepatitis C virus (HCV) and HCV RNA positive
- Must have chronic hepatitis C infection (genotype 1) with HCV RNA level greater than10000 IU/mL
- Patient must have failed at least 1 prior course of peg interferon (Peg-IFN-alfa-2a)/ribavirin (RBV) therapy (standard treatment)
- Must be willing to use 2 effective methods of birth control for up to 7 months after last dose of study medication
Exclusion Criteria
- Has an evidence of decompensated liver disease
- Co-infection with any other Hepatitis C virus genotype or co-infection with the human immunodeficiency virus (HIV)
- Has a medical condition which is a contraindication to Peg-INF or RBV therapy
- Have had history of, or any current medical condition which could impact the safety of the patient in the study
Data sourced from ClinicalTrials.gov (NCT00980330). 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.