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

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. According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (\< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.

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
Debiopharm International

30 total trials

What the finished NCT01183169 record still lists

NCT01183169 is an interventional study that assigns participants to a tested intervention. The registered 459 participants enrollment target is mid-sized for trials with a published cap, below the 1,886-participant average among 106 other Hepatitis C trials with a reported enrollment target (76% lower).

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 names 20 study sites across 10 states, led by 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.

Learn More About Clinical Trials

Similar trials for Hepatitis C

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01183169's enrollment target sits among peer trials

459 23rd of 106 higher than 84 of 106 other Hepatitis C trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hepatitis C 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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Related registry views

Source: ClinicalTrials.gov NCT01183169, the US trial registry maintained by the National Library of Medicine. NCT01183169 (mid enrollment · wide site footprint · completed) retrieved and formatted by PlainTrial, see methodology.