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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 is a Phase 3 study that has completed, run by Janssen R&D Ireland. The registered enrollment target is 771 participants.
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.
Interventions
- DRUG TMC435
- DRUG TVR
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 771 participants |
| Start Date | 2012-02 |
| Est. Completion | 2014-04 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01485991
The ClinicalTrials.gov registry entry for NCT01485991 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 771 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen R&D Ireland, which has 14 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which TMC435 is the first listed.
NCT01485991 reports 0 study locations.
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.
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