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NCT01290679 · ClinicalTrials.gov registry record · Phase 3
An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants
A Phase 3 study, sponsored by Janssen R&D Ireland.
- Completed
- Registry status
- Phase 3
- Development phase
- 393
- Enrollment target
NCT01290679: Completed Phase 3 study, sponsored by Janssen R&D Ireland.
NCT01290679 is a Phase 3 study that has completed, run by Janssen R&D Ireland. The registered enrollment target is 393 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
NCT01290679, a Phase 3 study, has completed, sponsored by Janssen R&D Ireland.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 393 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 alfa-2a or peginterferon alfa-2b 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 or Peginterferon alpha-2b (PegIFNα-2a/b)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 393 participants |
| Start Date | 2011-03 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
What the finished NCT01290679 record still lists
NCT01290679 is an interventional study that assigns participants to a tested intervention. The registered 393 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.
NCT01290679 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01290679 about?
NCT01290679 is a clinical study titled "An Efficacy, Safety, and Tolerability Study of TMC435 in Treatment-naive, Genotype 1 Hepatitis C-infected Participants". 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 alfa-2a or peginterferon alfa-2b and riba...
What is the current status of trial NCT01290679?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 393 participants. The study started on 2011-03. Estimated completion is 2013-02.
What interventions are being tested in trial NCT01290679?
The interventions under investigation include: Placebo (DRUG), Ribavirin (RBV) (DRUG), TMC435 (DRUG), Peginterferon alpha-2a or Peginterferon alpha-2b (PegIFNα-2a/b) (DRUG).
Who is sponsoring clinical trial NCT01290679?
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 NCT01290679's enrollment target sits among peer trials
393 967th 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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