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NCT01183169 · ClinicalTrials.gov registry record · Phase 2

Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

A Phase 2 study of Hepatitis C, sponsored by Debiopharm International.

Completed
Registry status
Phase 2
Development phase
459
Enrollment target
20
Study locations

NCT01183169 is a Phase 2 study of Hepatitis C that has completed, run by Debiopharm International. The registered enrollment target is 459 participants, below the 1,886-participant average among 106 other Hepatitis C trials with a reported enrollment target (76% lower). The trial reports 20 study locations across 10 states.

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The verdict

NCT01183169, a Phase 2 study of Hepatitis C, has completed, sponsored by Debiopharm International.

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

Study Summary

The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.

Conditions Studied

Hepatitis C

Interventions

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

Study Locations (20)

Texas

  • Novartis Investigative Site - Arlington
  • Novartis Investigative Site - Dallas
  • Novartis Investigative Site - Houston
  • Novartis Investigative Site - San Antonio

California

  • Novartis Investigative Site - San Diego
  • Novartis Investigative Site - San Diego
  • Novartis Investigative Site - Ventura

Florida

  • Novartis Investigative Site - Bradenton
  • Novartis Investigative Site - Orlando
  • Novartis Investigative Site - Tampa

Hawaii

  • Novartis Investigative Site - Honolulu
  • Novartis Investigative Site - Honolulu

New York

  • Novartis Investigative Site - Brooklyn
  • Novartis Investigative Site - New York

New South Wales

  • Novartis Investigative Site - Kingswood
  • Novartis Investigative Site - Kogarah

Illinois

  • Novartis Investigative Site - Springfield

Kansas

  • Novartis Investigative Site - Topeka

Trial Details

FieldValue
Enrollment Target 459 participants
Start Date 2010-08
Est. Completion 2013-05
Phase Phase 2

Sponsor

Debiopharm International

30 total trials

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What the Registry Record Tells You About NCT01183169

The ClinicalTrials.gov registry entry for NCT01183169 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 459 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,886-participant average among 106 other Hepatitis C trials with a reported enrollment target (76% lower). The listed sponsor is Debiopharm International, which has 30 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Hepatitis C appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT01183169 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Texas, California, Florida.

Frequently Asked Questions

What is clinical trial NCT01183169 about?

NCT01183169 is a clinical study titled "Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment". The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and...

What is the current status of trial NCT01183169?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 459 participants. The study started on 2010-08. Estimated completion is 2013-05.

What conditions does trial NCT01183169 study?

This clinical trial studies the following conditions: Hepatitis C.

What interventions are being tested in trial NCT01183169?

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

Who is sponsoring clinical trial NCT01183169?

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

Where is trial NCT01183169 being conducted?

This trial has 20 study locations across California, Florida, Hawaii, Illinois, Kansas. 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.