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NCT01281839 · ClinicalTrials.gov registry record · Phase 3
An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy
A Phase 3 study of Hepatitis C, sponsored by Janssen R&D Ireland.
- Completed
- Registry status
- Phase 3
- Development phase
- 394
- Enrollment target
- 20
- Study locations
NCT01281839: Completed Phase 3 study of Hepatitis C, sponsored by Janssen R&D Ireland.
NCT01281839 is a Phase 3 study of Hepatitis C that has completed, run by Janssen R&D Ireland. The registered enrollment target is 394 participants, below the 1,886-participant average among 106 other Hepatitis C trials with a reported enrollment target (79% lower). The trial reports 20 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01281839, a Phase 3 study of Hepatitis C, has completed, sponsored by Janssen R&D Ireland.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 394 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG Ribavirin (RBV)
- DRUG TMC435
- DRUG Peginterferon alpha-2a (PegIFN alpha-2a)
Study Locations (20)
Other
- - Adelaide
- - Kingswood
- - Melbourne
- - Sydney
- - Woolloongabba
- - Vienna
- - Antwerp
- - Bruges
- - Brussels
Florida
- - Jacksonville
- - Orlando
Texas
- - Houston
- - San Antonio
California
- - Bakersfield
Colorado
- - Aurora
Georgia
- - Atlanta
Kentucky
- - Crestview Hills
Minnesota
- - Saint Paul
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 394 participants |
| Start Date | 2011-02 |
| Est. Completion | 2013-02 |
| Phase | Phase 3 |
What the finished NCT01281839 record still lists
NCT01281839 is an interventional study that assigns participants to a tested intervention. The registered 394 participants enrollment target is mid-sized for trials with a published cap, below the 1,886-participant average among 106 other Hepatitis C trials with a reported enrollment target (79% lower).
The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT01281839 names 20 study sites across 10 states, led by Other, Florida, Texas.
Frequently Asked Questions
What is clinical trial NCT01281839 about?
NCT01281839 is a clinical study titled "An Efficacy, Safety and Tolerability Study of TMC435 in Genotype 1 Hepatitis C-infected Patients Who Relapsed After Previous Therapy". The purpose of this study is to investigate the effectiveness and safety of TMC435 compared with placebo in patients who are infected with genotype 1 hepatitis C virus who relapsed after previous interferon-based therapy. Patients will also receive peginterferon alfa-2a and ribavirin as part of thei...
What is the current status of trial NCT01281839?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 394 participants. The study started on 2011-02. Estimated completion is 2013-02.
What conditions does trial NCT01281839 study?
This clinical trial studies the following conditions: Hepatitis C.
What interventions are being tested in trial NCT01281839?
The interventions under investigation include: Placebo (DRUG), Ribavirin (RBV) (DRUG), TMC435 (DRUG), Peginterferon alpha-2a (PegIFN alpha-2a) (DRUG).
Who is sponsoring clinical trial NCT01281839?
This trial is sponsored by Janssen R&D Ireland, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01281839 being conducted?
This trial has 20 study locations across California, Colorado, Florida, Georgia, Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hepatitis C
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01281839's enrollment target sits among peer trials
394 29th of 106 higher than 78 of 106 other Hepatitis C trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hepatitis C 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
-
Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-naïve Genotype 1 Hepatitis C Infected Patients (STARTverso 2)
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SOF (Sovaldi®) +RBV for 16 or 24 Weeks and SOF+RBV+Peg-IFN for 12 Weeks in Adults With Genotype 2 or 3 Chronic HCV Infection
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Safety and Efficacy of Sofosbuvir/Velpatasvir/Voxilaprevir and Sofosbuvir/Velpatasvir in Adults With Chronic HCV Infection Who Have Not Previously Received Treatment With Direct-Acting Antiviral Therapy
COMPLETED · Phase 3
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