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NCT01309932 · ClinicalTrials.gov registry record · Phase 2

Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin

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

Completed
Registry status
Phase 2
Development phase
165
Enrollment target
20
Study locations

NCT01309932 is a Phase 2 study of Hepatitis C that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 165 participants, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (91% lower). The trial reports 20 study locations across 15 states.

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The verdict

NCT01309932, a Phase 2 study of Hepatitis C, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 2
Development phase
165 participants
Enrollment target
20
Study locations

Study Summary

The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standard therapy with Pegylated Interferon Alpha-2a plus RBV for 48 weeks.

Conditions Studied

Interventions

  • BIOLOGICAL Pegylated Interferon Lambda (pegIFNλ)
  • DRUG BMS-790052 (NS5A Inhibitor)
  • DRUG Ribavirin (RBV)
  • DRUG BMS-650032 (NS3 Protease Inhibitor)
  • BIOLOGICAL Pegylated Interferon Alfa-2a (pegIFNα-2a)

Study Locations (20)

Other

  • Local Institution - Clichy
  • Local Institution - Créteil
  • Local Institution - Montpellier

North Carolina

  • Carolinas Medical Center - Charlotte
  • Carolinas Center For Liver Disease - Statesville

Texas

  • St. Luke'S Episcopal Hospital - Baylor College Of Medicine - Houston
  • Texas Liver Institute - San Antonio

Victoria

  • Local Institution - Clayton Vic
  • Local Institution - Heidelberg

Arizona

  • Mayo Clinic Hospital - Phoenix

California

  • Desert Medical Group Inc. - Palm Springs

Colorado

  • University Of Colorado Denver And Hospital - Aurora

Connecticut

  • Yale University School Of Medicine - New Haven

Trial Details

FieldValue
Enrollment Target 165 participants
Start Date 2011-03
Est. Completion 2014-09
Phase Phase 2

Sponsor

Bristol-Myers Squibb

1,025 total trials

What the Registry Record Tells You About NCT01309932

The ClinicalTrials.gov registry entry for NCT01309932 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 165 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,889-participant average among 106 other Hepatitis C trials with a reported enrollment target (91% lower). The listed sponsor is Bristol-Myers Squibb, which has 1,025 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 5 interventions - of which Pegylated Interferon Lambda (pegIFNλ) is the first listed.

NCT01309932 reports 20 study locations spanning 15 distinct geographic areas - top geographies include Other, North Carolina, Texas.

Frequently Asked Questions

What is clinical trial NCT01309932 about?

NCT01309932 is a clinical study titled "Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin". The purpose of this study is to determine if combination therapy with Pegylated Interferon Lambda (BMS-914143) plus Ribavirin (RBV) with a single direct antiviral agent (BMS-790052 or BMS-650032) for 24 weeks is effective and safe for treatment of Chronic Hepatitis C (CHC) compared to current standa...

What is the current status of trial NCT01309932?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 165 participants. The study started on 2011-03. Estimated completion is 2014-09.

What conditions does trial NCT01309932 study?

This clinical trial studies the following conditions: Hepatitis C.

What interventions are being tested in trial NCT01309932?

The interventions under investigation include: Pegylated Interferon Lambda (pegIFNλ) (BIOLOGICAL), BMS-790052 (NS5A Inhibitor) (DRUG), Ribavirin (RBV) (DRUG), BMS-650032 (NS3 Protease Inhibitor) (DRUG), Pegylated Interferon Alfa-2a (pegIFNα-2a) (BIOLOGICAL).

Who is sponsoring clinical trial NCT01309932?

This trial is sponsored by Bristol-Myers Squibb, which has 1,025 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01309932 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Connecticut, Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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.