Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT01485991 · ClinicalTrials.gov registry record · Phase 3
TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy
A Phase 3 study, sponsored by Janssen R&D Ireland.
- Completed
- Registry status
- Phase 3
- Development phase
- 771
- Enrollment target
NCT01485991: Completed Phase 3 study, sponsored by Janssen R&D Ireland.
NCT01485991 is a Phase 3 study that has completed, run by Janssen R&D Ireland. The registered enrollment target is 771 participants, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01485991, a Phase 3 study, has completed, sponsored by Janssen R&D Ireland.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 771 participants
- Enrollment target
Study Summary
The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.
Primary Outcome
Participants are considered to have reached SVR12 if both conditions below are met: 1) HCV RNA levels less than (\<) 25 International unit per milliliter (IU/mL) undetectable; 2) HCV RNA levels \<25 IU/mL undetectable or HCV RNA levels \<25 IU/mL detectable.
Interventions
- DRUG TMC435
- DRUG TVR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 771 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
What the finished NCT01485991 record still lists
NCT01485991 is an interventional study that assigns participants to a tested intervention. The registered 771 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target.
The record links to 0 conditions, and to 2 interventions - of which TMC435 is the first listed.
NCT01485991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01485991 about?
NCT01485991 is a clinical study titled "TMC435HPC3001 - An Efficacy, Safety and Tolerability Study for TMC435 vs Telaprevir in Combination With PegINFα-2a and Ribavirin in Chronic Hepatitis C Patients Who Were Null or Partial Responders to Prior PegINFα-2a and Ribavirin Therapy". The purpose of this study is to demonstrate the efficacy of TMC435 in combination with peginterferon (PegIFN) + ribavirin (RBV) by means of establishing its non- inferiority compared to an approved regimen of telaprevir + PegIFN + RBV in patients who have previously failed PegIFN.
What is the current status of trial NCT01485991?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 771 participants. The study started on 2012-02. Estimated completion is 2014-04.
What interventions are being tested in trial NCT01485991?
The interventions under investigation include: TMC435 (DRUG), TVR (DRUG).
Who is sponsoring clinical trial NCT01485991?
This trial is sponsored by Janssen R&D Ireland, which has 14 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01485991's enrollment target sits among peer trials
771 440th of 2000 higher than 1,561 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT05977348 · 770 participants · NA
Increasing Food Literacy in Preschoolers to Reduce Obesity Risk
- NCT06376994 · 770 participants · Phase 3
Multi-Center Clean Air Randomized Controlled Trial in COPD
- NCT06824467 · 770 participants · Phase 3
A Study to Evaluate the Efficacy and Safety of Sacituzumab Tirumotecan (MK-2870) Maintenance Treatment Versus Standard of Care in Participants With Platinum-sensitive Recurrent Ovarian Cancer (MK-2870-022/TroFuse-022/ENGOT-ov84/GOG-3103)
- NCT06907173 · 770 participants · Phase 3
Ketamine add-on Therapy for Established Status Epilepticus Treatment Trial (KESETT)
Similar registry start date
- NCT05988463 · started 2027-01-01 · Phase 1
Dose-Escalation Study of Artesunate Patients With IPF
- NCT07219706 · started 2026-12-10 · NA
Dietary Fiber and Time Restricted Eating
- NCT02831335 · started 2026-12-01
Technical Development of Multi-Parametric Renocerebral MRI
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia