Phase 3
N=391
An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT01290679 ↗Enrolled (actual)
391
Serious AEs
6.7%
Results posted
Jun 2014
Primary outcome: Primary: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) — 81.3; 50.0 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); TMC435 (Drug); Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b) (Drug); Ribavirin (RBV) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen R&D Ireland
- Primary completion
- Feb 2013
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) |
81.3; 50.0 | <0.001 sig |
| SECONDARY The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72) |
78.6; 50.0 | <0.001 sig |
| SECONDARY The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24) |
80.5; 50.0 | <0.001 sig |
| SECONDARY The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4) |
84.8; 53.0 | <0.001 sig |
| SECONDARY Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) |
-3.60; -1.22; -4.52; -1.21; -5.28; -2.72 | — |
| SECONDARY Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) |
2.777; 5.165; 1.852; 5.171; 1.093; 3.657 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Response at All Time Points |
0.4; 0; 6.3; 1.5; 31.7; 3.8 | — |
| SECONDARY The Percentage of Participants Achieving a Rapid Virologic Response (RVR) |
79.2; 12.8 | — |
| SECONDARY The Percentage of Participants Achieving a Early Virologic Response (EVR) |
98.8; 89.8 | — |
| SECONDARY The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR) |
96.8; 44.9 | — |
| SECONDARY The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR) |
78.3; 13.4 | — |
| SECONDARY The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4 |
0.4; 17.3 | — |
| SECONDARY Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4 |
1.2; 61.2 | — |
| SECONDARY Percentage of Participants With Null Response |
1.2; 10.2 | — |
| SECONDARY Percentage of Participants With Partial Response |
0.4; 17.3 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
4.7; 10.4 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
12.3; 23.9 | — |
| SECONDARY Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule |
89.5; NA | — |
| SECONDARY Percentage of Participants With On-treatment Failure |
7.0; 32.1 | — |
| SECONDARY Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable |
14; 85 | — |
| SECONDARY Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable |
29; 113 | — |
| SECONDARY Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL |
8; 71 | — |
| SECONDARY Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL |
4; 57 | — |
| SECONDARY The Percentage of Participants With Viral Breakthrough at Different Time Points |
1.2; 3.7; 3.3; 6.4; 12.5; 2.1 | — |
| SECONDARY Time From End-of-treatment to Viral Relapse |
229.77; 77.74 | — |
| SECONDARY The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) |
79.9; 81.0 | — |
| SECONDARY Median Time to Normalization of Alanine Aminotransferase (ALT) Levels |
2.14; 4.14 | — |
| SECONDARY Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) |
56611 | — |
| SECONDARY Plasma Concentration of TMC435: Predose Plasma Concentration (C0h) |
1902 | — |
| SECONDARY Plasma Concentration of TMC435: Systemic Clearance (CL) |
5.23 | — |
| SECONDARY Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores |
208.418; 225.194; 240.695; 259.532 | 0.008 sig |
| SECONDARY Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Due to Hepatitis C Virus (HCV) Infection and Its Treatment |
1628.075; 1910.235; 1781.768; 2106.131 | 0.008 sig |
| SECONDARY Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activities Due to Hepatitis C Virus (HCV) Infection and Its Treatment |
1580.635; 1863.071; 1727.079; 2056.283 | 0.007 sig |
| SECONDARY Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Time Missed From Work Due to Hepatitis C Virus (HCV) Infection and Its Treatment |
653.642; 840.495; 698.223; 886.425 | 0.125 |
Summary
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in participants who are infected with genotype 1 hepatitis C virus who have never received treatment before. Participants will also receive peginterferon alfa-2a or peginterferon alfa-2b and ribavirin as part of their treatment.
Eligibility Criteria
Inclusion Criteria
- Genotype 1 hepatitis C infection (confirmed at screening)
- Participant has not received any prior treatment for hepatitis C
- Participant must have had a liver biopsy within 3 years before screening (or between the screening and baseline visit) showing chronic hepatitis C infection
- Must agree to use 2 forms of effective contraception throughout study (both males and females)
Exclusion Criteria
- Infection with HIV or non genotype 1 hepatitis C
- Liver disease not related to hepatitic C infection
- Hepatic decompensation
- Significant laboratory abnormalities or other active diseases
- Pregnant or planning to become pregnant
Data sourced from ClinicalTrials.gov (NCT01290679). 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.