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NCT01428063 · ClinicalTrials.gov registry record · Phase 2

Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials

A Phase 2 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 2
Development phase
276
Enrollment target

NCT01428063: Completed Phase 2 study, sponsored by Bristol-Myers Squibb.

NCT01428063 is a Phase 2 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 276 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (108% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01428063, a Phase 2 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
276 participants
Enrollment target

Study Summary

The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. Approximately 100 genotype 1b patients who received placebo in BMS study NCT01428063 (AI447-028) will receive active drugs in this study.

Primary Outcome

SVR12 defined as HCV RNA\<limit of quantitation at follow-up Week 12. Nonresponder (NR)=prior NR to pegIFN-2a or ribavirin.

Interventions

  • DRUG Ribavirin
  • DRUG Daclatasvir
  • DRUG Pegylated interferon alfa-2a
  • DRUG Asunaprevir

Trial Details

FieldValue
Enrollment Target 276 participants
Start Date 2011-09
Est. Completion 2014-12
Phase Phase 2
Bristol-Myers Squibb

1,025 total trials

What the finished NCT01428063 record still lists

NCT01428063 is an interventional study that assigns participants to a tested intervention. The registered 276 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (108% higher).

The record links to 0 conditions, and to 4 interventions - of which Ribavirin is the first listed.

NCT01428063 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01428063 about?

NCT01428063 is a clinical study titled "Study of pegInterferon Alfa-2a, Ribavirin, and Daclatasvir (BMS-790052) With or Without BMS-650032 for Participants in Some Hepatitis C Virus Trials". The purpose of this study is to provide anti-hepatitis C virus drugs to patients who received placebo + peginterferon alfa-2a + ribavirin in prior Bristol-Myers Squibb (BMS) studies and determine whether addition of these drugs results in higher cure rates in patients who previously failed therapy. ...

What is the current status of trial NCT01428063?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 276 participants. The study started on 2011-09. Estimated completion is 2014-12.

What interventions are being tested in trial NCT01428063?

The interventions under investigation include: Ribavirin (DRUG), Daclatasvir (DRUG), Pegylated interferon alfa-2a (DRUG), Asunaprevir (DRUG).

Who is sponsoring clinical trial NCT01428063?

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 NCT01428063's enrollment target sits among peer trials

276 202nd of 2000 higher than 1,798 of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 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 NCT01428063, the US trial registry maintained by the National Library of Medicine. NCT01428063 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.