Phase 3
Completed N=393
An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy
Source: ClinicalTrials.gov NCT01281839 ↗Enrolled (actual)
393
Serious AEs
6.4%
Results posted
Apr 2014
Primary outcomePrimary: The Percentage of Participants Achieving a Sustained Virologic Response 12 Weeks After the Planned End of Treatment (SVR12) — 79.2; 36.1 Percentage of participants — p=<0.001
Summary
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and ribavirin as part of their treatment.
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) |
79.2; 36.1 | <0.001 sig |
| SECONDARY The Percentage of Participants Achieving a Sustained Virologic Response at Week 72 (SVRW72) |
76.5; 33.8 | <0.001 sig |
| SECONDARY The Percentage of Participants Who Achieved a Sustained Virologic Response 24 Weeks After the Planned End of Treatment (SVR24) |
77.3; 33.8 | <0.001 sig |
| SECONDARY The Percentage of Participants Who Achieved a Sustained Virologic Response 4 Weeks After the Planned End of Treatment (SVR4) |
88.5; 48.1 | <0.001 sig |
| SECONDARY Change From Baseline in log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) |
-3.537; -1.039; -4.535; -1.099; -5.295; -2.638 | — |
| SECONDARY Actual Values of log10 Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) |
2.884; 5.445; 1.889; 5.376; 1.128; 3.838 | — |
| SECONDARY The Percentage of Participants With On-treatment Virologic Response at All Time Points |
0; 0.8; 3.9; 0; 28.3; 0.8 | — |
| SECONDARY The Percentage of Participants Achieving a Rapid Virologic Response (RVR) |
77.2; 3.1 | — |
| SECONDARY The Percentage of Participants Achieving a Early Virologic Response (EVR) |
98.8; 95.2 | — |
| SECONDARY The Percentage of Participants Achieving a Complete Early Virologic Response (cEVR) |
98.0; 27.4 | — |
| SECONDARY The Percentage of Participants Achieving a Extended Rapid Virologic Response (eRVR) |
77.6; 1.6 | — |
| SECONDARY The Percentage of Participants With <1 log10 Decrease in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) From Baseline at Week 4 |
0.8; 9.3 | — |
| SECONDARY Percentage of Participants With in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels >1000 IU/mL at Week 4 |
1.9; 69.9 | — |
| SECONDARY The Percentage of Participants With Null Response |
1.2; 4.8 | — |
| SECONDARY The Percentage of Participants With Partial Response |
10.5; 0 | — |
| SECONDARY The Percentage of Participants With Viral Breakthrough |
0.0; 2.3 | — |
| SECONDARY The Percentage of Participants With Viral Relapse |
18.9; 50.5 | — |
| SECONDARY The Percentage of Participants Who Completed All Study Treatment at Week 24 Because of the Treatment Duration Rule |
90.0; 0 | — |
| SECONDARY The Percentage of Participants With On-treatment Failure |
3.1; 27.1 | — |
| SECONDARY Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable |
28; 141 | — |
| SECONDARY Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <25 IU/mL Undetectable or Detectable |
14; 110 | — |
| SECONDARY Time to Reach Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) <100 IU/mL |
8; 85 | — |
| 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 |
1.9; 0.0; 0.0; 0.0; 10.0; 0.0 | — |
| SECONDARY Time From End-of-treatment to Viral Relapse |
284.09; 115.22 | — |
| SECONDARY The Percentage of Participants With Normalization of Alanine Aminotransferase (ALT) |
69.9; 69.0 | — |
| SECONDARY Median Time to Normalization of Alanine Aminotransferase (ALT) Levels |
7.86; 8.00 | — |
| SECONDARY Plasma Concentration of TMC435: Area Under the Plasma Concentration-time Curve From the Time of Administration to 24 Hours After Dosing (AUC24h) |
60987 | — |
| SECONDARY Plasma Concentration of TMC435: Predose Plasma Concentration (C0h) |
2081 | — |
| SECONDARY Plasma Concentration of TMC435: Systemic Clearance (CL) |
4.92 | — |
Eligibility Criteria
Inclusion Criteria
- Genotype 1 hepatitis C infection (confirmed at screening)
- Have previously received peginterferon-based therapy for at least 24 weeks with documented HCV RNA at last measurement and relapsed within 1 year of last taking medication
- 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 (NCT01281839). 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.