Phase 3
N=394
An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients
Hepatitis C
Bottom Line
View on ClinicalTrials.gov: NCT01289782 ↗Enrolled (actual)
394
Serious AEs
4.6%
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) — 79.5; 50 Percentage of participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); TMC435 (Drug); Peginterferon alpha-2a (PegIFN alpha-2a) (Drug); Ribavirin (RBV) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Janssen R&D Ireland
- Primary completion
- Jan 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) |
79.5; 50 | <0.001 sig |
| SECONDARY The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72) |
78.4; 49.2 | <0.001 sig |
| SECONDARY The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24) |
79.5; 49.2 | <0.001 sig |
| SECONDARY The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4) |
82.2; 56.2 | <0.001 sig |
| SECONDARY Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) |
-3.52; -0.93; -4.47; -1.08; -5.22; -2.56 | — |
| SECONDARY Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) |
2.914; 5.351; 1.973; 5.202; 1.223; 3.723 | — |
| SECONDARY Percentage of Participants With On-treatment Virologic Response at All Time Points |
0.4; 0.8; 6.6; 0.8; 35.8; 2.3 | — |
| SECONDARY The Percentage of Participants Achieving a Rapid Virologic Response (RVR) |
79.5; 11.8 | — |
| SECONDARY The Percentage of Participants Achieving a Early Virologic Response (EVR) |
99.2; 85.2 | — |
| SECONDARY The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR) |
92.8; 50.8 | — |
| SECONDARY The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR) |
78.9; 11.7 | — |
| SECONDARY The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4 |
0; 15.7 | — |
| SECONDARY Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4 |
4.5; 63.8 | — |
| SECONDARY Percentage of Participants With Null Response |
0.8; 14.8 | — |
| SECONDARY Percentage of Participants With Partial Response |
3.2; 13.1 | — |
| SECONDARY Percentage of Participants With Viral Breakthrough |
4.9; 7.7 | — |
| SECONDARY Percentage of Participants With Viral Relapse |
9.0; 22.6 | — |
| SECONDARY Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule |
83; NA | — |
| SECONDARY Percentage of Participants With On-treatment Failure |
9.1; 33.8 | — |
| 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 |
28; 111 | — |
| SECONDARY Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL |
28; 84 | — |
| SECONDARY Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <1000 IU/mL |
4; 56.5 | — |
| SECONDARY The Percentage of Participants With Viral Breakthrough at Different Time Points |
2.7; 1.5; 2.5; 6.8; 0; 1.2 | — |
| SECONDARY Time From End-of-treatment to Viral Relapse |
100.96; 146.04 | — |
| SECONDARY The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) |
81.0; 77.5 | — |
| SECONDARY Median Time to Normalization of Alanine Aminotransferase (ALT) Levels |
2.14; 8.14 | — |
| SECONDARY Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) |
54795 | — |
| SECONDARY Plasma Concentration of TMC435: Predose Plasma Concentration (C0h) |
1825 | — |
| SECONDARY Plasma Concentration of TMC435: Systemic Clearance (CL) |
5.05 | — |
| SECONDARY Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for the Fatigue Severity Scale (FSS) Total Scores |
214.907; 235.586; 250.522; 274.322 | <0.001 sig |
| SECONDARY Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Overall Work Productivity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment |
1555.204; 1785.668; 1718.241; 1966.449 | 0.030 sig |
| SECONDARY Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) for Impairment in Daily Activity Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment |
1514.400; 1792.460; 1667.735; 1975.457 | 0.009 sig |
| SECONDARY Area Under the Curve From Baseline to Week 60 (AUC60) and Week 72 (AUC72) in Work Productivity and Activity (WPAI) Absenteeism Scores Due to Hepatitis C Virus (HCV) Infection and Its Treatment |
447.170; 400.771; 487.449; 430.285 | 0.642 |
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 alpha-2a and ribavirin as part of their treatment.
Eligibility Criteria
Inclusion Criteria
- Genotype 1 hepatitis C infection (confirmed at screening)
- Patient has not received any prior treatment for hepatitis C
- Patient 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 (NCT01289782). 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.