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NCT01289782 · ClinicalTrials.gov registry record · Phase 3
An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients
A Phase 3 study, sponsored by Janssen R&D Ireland.
- Completed
- Registry status
- Phase 3
- Development phase
- 395
- Enrollment target
NCT01289782: Completed Phase 3 study, sponsored by Janssen R&D Ireland.
NCT01289782 is a Phase 3 study that has completed, run by Janssen R&D Ireland. The registered enrollment target is 395 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01289782, a Phase 3 study, has completed, sponsored by Janssen R&D Ireland.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 395 participants
- Enrollment target
Study 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.
Primary Outcome
The table below shows the percentage of participants in each treatment group who achieved a SVR12, defined as the percentage of participants with undetectable plasma Hepatitis C virus ribonucleic acid 12 weeks after planned end of treatment.
Interventions
- DRUG Placebo
- DRUG Ribavirin (RBV)
- DRUG TMC435
- DRUG Peginterferon alpha-2a (PegIFN alpha-2a)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 395 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-01 |
| Phase | Phase 3 |
What the finished NCT01289782 record still lists
NCT01289782 is an interventional study that assigns participants to a tested intervention. The registered 395 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (49% lower).
The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01289782 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01289782 about?
NCT01289782 is a clinical study titled "An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Patients". 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 t...
What is the current status of trial NCT01289782?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 395 participants. The study started on 2011-02. Estimated completion is 2013-01.
What interventions are being tested in trial NCT01289782?
The interventions under investigation include: Placebo (DRUG), Ribavirin (RBV) (DRUG), TMC435 (DRUG), Peginterferon alpha-2a (PegIFN alpha-2a) (DRUG).
Who is sponsoring clinical trial NCT01289782?
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 NCT01289782's enrollment target sits among peer trials
395 965th of 2000 higher than 1,034 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
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