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NCT01598090 · ClinicalTrials.gov registry record · Phase 3

Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir

A Phase 3 study, sponsored by Bristol-Myers Squibb.

Completed
Registry status
Phase 3
Development phase
881
Enrollment target

NCT01598090: Completed Phase 3 study, sponsored by Bristol-Myers Squibb.

NCT01598090 is a Phase 3 study that has completed, run by Bristol-Myers Squibb. The registered enrollment target is 881 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01598090, a Phase 3 study, has completed, sponsored by Bristol-Myers Squibb.

COMPLETED
Registry status
Phase 3
Development phase
881 participants
Enrollment target

Study Summary

The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

Primary Outcome

eRVR was defined as Hepatitis C virus (HCV) RNA level below the lower limit of quantitation, target not detected at Weeks 4 and 12 of treatment. HCV RNA level was measured using the Roche COBAS® TaqMan HCV Test v.2.0 (lower limit of quantitation =25 IU/mL; limit of detection \~ 10 IU/mL).

Interventions

  • DRUG Ribavirin
  • DRUG Telaprevir
  • BIOLOGICAL Peginterferon Lambda-1a
  • BIOLOGICAL Peginterferon Alfa-2a

Trial Details

FieldValue
Enrollment Target 881 participants
Start Date 2012-06-14
Est. Completion 2015-05-15
Phase Phase 3
Bristol-Myers Squibb

1,025 total trials

What the finished NCT01598090 record still lists

NCT01598090 is an interventional study that assigns participants to a tested intervention. The registered 881 participants enrollment target is mid-sized for trials with a published cap, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (14% higher).

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

NCT01598090 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01598090 about?

NCT01598090 is a clinical study titled "Phase 3 Efficacy and Safety Study of Peginterferon Lambda-1a and Ribavirin With Telaprevir". The purpose of this study is to determine whether Peginterferon Lambda-1a (Lambda) combined with Ribavirin (RBV) and Telaprevir (TVR) is effective in the treatment of chronic Hepatitis C (CHC) compared to Peginterferon Alfa-2a (alfa-2a) combined with RBV and Telaprevir.

What is the current status of trial NCT01598090?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 881 participants. The study started on 2012-06-14. Estimated completion is 2015-05-15.

What interventions are being tested in trial NCT01598090?

The interventions under investigation include: Ribavirin (DRUG), Telaprevir (DRUG), Peginterferon Lambda-1a (BIOLOGICAL), Peginterferon Alfa-2a (BIOLOGICAL).

Who is sponsoring clinical trial NCT01598090?

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 NCT01598090's enrollment target sits among peer trials

881 367th of 2000 higher than 1,634 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 NCT01598090, the US trial registry maintained by the National Library of Medicine. NCT01598090 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.