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NCT01479868 · ClinicalTrials.gov registry record · Phase 3
A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1
A Phase 3 study of Hepatitis C Virus Genotype-1, sponsored by Janssen R&D Ireland.
- Completed
- Registry status
- Phase 3
- Development phase
- 109
- Enrollment target
- 20
- Study locations
NCT01479868 is a Phase 3 study of Hepatitis C Virus Genotype-1 that has completed, run by Janssen R&D Ireland. The registered enrollment target is 109 participants. The trial reports 20 study locations across 11 states.
The verdict
NCT01479868, a Phase 3 study of Hepatitis C Virus Genotype-1, has completed, sponsored by Janssen R&D Ireland.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 109 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number of patients with sustained virologic response (SVR) at 12 weeks after the planned end of treatment.
Conditions Studied
Interventions
- DRUG Ribavirin
- DRUG TMC435
- DRUG Pegylated interferon alpha-2a
Study Locations (20)
Other
- - Lyon
- - Montpellier
- - Nantes
- - Paris
- - Berlin
- - Bonn
- - Cologne
- - Düsseldorf
New York
- - Albany
- - New York
Texas
- - Dallas
- - Houston
California
- - Los Angeles
District of Columbia
- - Washington D.C.
Florida
- - Orlando
Georgia
- - Atlanta
Illinois
- - Chicago
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2011-10 |
| Est. Completion | 2013-08 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01479868
The ClinicalTrials.gov registry entry for NCT01479868 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 109 participants, a figure that helps gauge the scale of data the investigators plan to collect. 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 Virus Genotype-1 appearing as the primary indexed condition, and to 3 interventions - of which Ribavirin is the first listed.
NCT01479868 reports 20 study locations spanning 11 distinct geographic areas - top geographies include Other, New York, Texas.
Frequently Asked Questions
What is clinical trial NCT01479868 about?
NCT01479868 is a clinical study titled "A Study to Assess the Safety, Tolerability and Efficacy of TMC435 Along With Pegylated Interferon Alpha-2a (Pegasys) and Ribavirin (Copegus) Triple Therapy in Chronic Hepatitis C Genotype-1 Infected Patients Co-infected With Human Immunodeficiency Virus-Type 1". The purpose of this study is to evaluate the safety and tolerability of TMC435 along with pegylated interferon alpha-2a (PegIFNα-2a) and ribavirin (RBV) triple therapy in hepatitis C virus genotype-1 infected subjects, co-infected with human immunodeficiency virus-type 1, and to evaluate the number ...
What is the current status of trial NCT01479868?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 109 participants. The study started on 2011-10. Estimated completion is 2013-08.
What conditions does trial NCT01479868 study?
This clinical trial studies the following conditions: Hepatitis C Virus Genotype-1.
What interventions are being tested in trial NCT01479868?
The interventions under investigation include: Ribavirin (DRUG), TMC435 (DRUG), Pegylated interferon alpha-2a (DRUG).
Who is sponsoring clinical trial NCT01479868?
This trial is sponsored by Janssen R&D Ireland, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01479868 being conducted?
This trial has 20 study locations across California, District of Columbia, Florida, Georgia, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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