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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: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.

NCT01718158 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 444 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower). According to ClinicalTrials.gov, the official US trial registry.

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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

FieldValue
Enrollment Target 444 participants
Start Date 2013-01
Est. Completion 2014-10
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the finished NCT01718158 record still lists

NCT01718158 is an interventional study that assigns participants to a tested intervention. The registered 444 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (42% lower).

The record links to 0 conditions, and to 5 interventions - of which Ribavirin is the first listed.

NCT01718158 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT01718158's enrollment target sits among peer trials

444 864th of 2000 higher than 1,135 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 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

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Source: ClinicalTrials.gov NCT01718158, the US trial registry maintained by the National Library of Medicine. NCT01718158 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.