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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01281839
The ClinicalTrials.gov registry entry for NCT01281839 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 394 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,886-participant average among 106 other Hepatitis C trials with a reported enrollment target (79% lower). The listed sponsor is Janssen R&D Ireland, which has 14 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 10 distinct geographic areas - top geographies include 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.
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Related
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