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NCT01718158 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy
A Phase 3 study, sponsored by Bristol-Myers Squibb.
- Completed
- Registry status
- Phase 3
- Development phase
- 444
- Enrollment target
NCT01718158 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 444 participants.
The verdict
NCT01718158, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 444 participants
- Enrollment target
Study Summary
The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment with Pegylated Interferon Alfa + Ribavirin
Interventions
- DRUG Ribavirin
- DRUG Daclatasvir
- DRUG Telaprevir
- BIOLOGICAL Peginterferon Lambda-1a
- BIOLOGICAL Peginterferon Alfa-2a
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 444 participants |
| Start Date | 2013-01 |
| Est. Completion | 2014-10 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01718158
The ClinicalTrials.gov registry entry for NCT01718158 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 444 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 5 interventions - of which Ribavirin is the first listed.
NCT01718158 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01718158 about?
NCT01718158 is a clinical study titled "Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy". The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a, given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in subjects who are infected wit...
What is the current status of trial NCT01718158?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 444 participants. The study started on 2013-01. Estimated completion is 2014-10.
What interventions are being tested in trial NCT01718158?
The interventions under investigation include: Ribavirin (DRUG), Daclatasvir (DRUG), Telaprevir (DRUG), Peginterferon Lambda-1a (BIOLOGICAL), Peginterferon Alfa-2a (BIOLOGICAL).
Who is sponsoring clinical trial NCT01718158?
This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.
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