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NCT01466790 · ClinicalTrials.gov registry record · Phase 2
A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients
A Phase 2 study, sponsored by Janssen R&D Ireland.
- Completed
- Registry status
- Phase 2
- Development phase
- 168
- Enrollment target
NCT01466790: Completed Phase 2 study, sponsored by Janssen R&D Ireland.
NCT01466790 is a Phase 2 study that has completed, run by Janssen R&D Ireland. The registered enrollment target is 168 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01466790, a Phase 2 study, has completed, sponsored by Janssen R&D Ireland.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 168 participants
- Enrollment target
Study Summary
The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977 (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1 hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or are HCV treatment-naive (patients who never received treatment for HCV infection).
Primary Outcome
Participants with hepatitis C virus (HCV) ribonucleic acid (RNA) undetectable at end of treatment and HCV RNA less than (\<) 25 international unit per milliliter (IU/mL) (detectable or undetectable) at 12 weeks after the planned end of treatment.
Interventions
- DRUG Ribavirin
- DRUG TMC435
- DRUG PSI-7977 (GS7977)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 168 participants |
| Start Date | 2012-01 |
| Est. Completion | 2014-01 |
| Phase | Phase 2 |
What the finished NCT01466790 record still lists
NCT01466790 is an interventional study that assigns participants to a tested intervention. The registered 168 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (26% higher).
The record links to 0 conditions, and to 3 interventions - of which Ribavirin is the first listed.
NCT01466790 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01466790 about?
NCT01466790 is a clinical study titled "A Study of TMC435 in Combination With PSI-7977 (GS7977) in Chronic Hepatitis C Genotype 1-Infected Prior Null Responders To Peginterferon/Ribavirin Therapy or HCV Treatment-Naive Patients". The purpose of this study is to investigate the efficacy and safety of TMC435 plus PSI-7977 (GS7977) with or without ribavirin in patients who are chronically infected with genotype 1 hepatitis C virus (HCV) and who did not respond to prior peginterferon/ribavirin therapy or are HCV treatment-naive ...
What is the current status of trial NCT01466790?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 168 participants. The study started on 2012-01. Estimated completion is 2014-01.
What interventions are being tested in trial NCT01466790?
The interventions under investigation include: Ribavirin (DRUG), TMC435 (DRUG), PSI-7977 (GS7977) (DRUG).
Who is sponsoring clinical trial NCT01466790?
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 NCT01466790's enrollment target sits among peer trials
168 403rd of 2000 higher than 1,595 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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
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