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NCT01318694 · ClinicalTrials.gov registry record · Phase 3

Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants

A Phase 3 study, sponsored by Debiopharm International.

Completed
Registry status
Phase 3
Development phase
1,081
Enrollment target

NCT01318694 is a Phase 3 study that has completed, run by Debiopharm International. The registered enrollment target is 1,081 participants.

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The verdict

NCT01318694, a Phase 3 study, has completed, sponsored by Debiopharm International.

COMPLETED
Registry status
Phase 3
Development phase
1,081 participants
Enrollment target

Study Summary

This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

Interventions

  • DRUG Ribavirin
  • DRUG Peginterferon alfa-2a
  • DRUG Alisporivir
  • DRUG ALV Placebo

Trial Details

FieldValue
Enrollment Target 1,081 participants
Start Date 2011-03
Est. Completion 2013-08
Phase Phase 3

Sponsor

Debiopharm International

30 total trials

What the Registry Record Tells You About NCT01318694

The ClinicalTrials.gov registry entry for NCT01318694 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 1,081 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Debiopharm International, which has 30 total studies on file at ClinicalTrials.gov.

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

NCT01318694 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT01318694 about?

NCT01318694 is a clinical study titled "Efficacy and Safety of Alisporivir Triple Therapy in Chronic Hepatitis C Genotype 1 Treatment-naïve Participants". This study will assess the safety and efficacy of alisporivir (ALV; DEB025) triple therapy \[i.e., when added to peginterferon alfa-2a (PEG) and ribavirin (RBV)\] to optimize treatment in treatment-naïve participants with hepatitis C virus (HCV) genotype 1 (GT1)

What is the current status of trial NCT01318694?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,081 participants. The study started on 2011-03. Estimated completion is 2013-08.

What interventions are being tested in trial NCT01318694?

The interventions under investigation include: Ribavirin (DRUG), Peginterferon alfa-2a (DRUG), Alisporivir (DRUG), ALV Placebo (DRUG).

Who is sponsoring clinical trial NCT01318694?

This trial is sponsored by Debiopharm International, which has 30 total clinical trials registered on ClinicalTrials.gov.

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.