Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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 is a Phase 3 study that has completed, run by Janssen R&D Ireland. The registered enrollment target is 395 participants.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01289782
The ClinicalTrials.gov registry entry for NCT01289782 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 395 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 0 conditions, and to 4 interventions - of which Placebo is the first listed.
NCT01289782 reports 0 study locations.
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
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.