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Completed Phase 2 Interventional Results available

Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

ClinicalTrials.gov ID: NCT01215643

Public ClinicalTrials.gov record NCT01215643. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Nov 6, 2026, 11:35 AM EST

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Official title

A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

Study identification

NCT ID
NCT01215643
Recruitment status
Completed
Study type
Interventional
Phase
Phase 2
Lead sponsor
Debiopharm International SA
Industry
Enrollment
340 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 70 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 2010 (Type not available)
Primary completion
May 2012 (Actual)
Completion
May 2012 (Actual)
Last update posted
Aug 30, 2016

2010 – 2012

United States locations

U.S. sites
16
U.S. states
8
U.S. cities
12
Facility City State ZIP Site status
Scripps Clinic La Jolla California 92037 —
Sharp Rees-Stealy Medical Group, Inc. San Diego California 92101 —
Research and Education Inc. San Diego California 92105 —
Island View Gastroenterology Associates Ventura California 93003 —
Hawai Medical Center East LLC Honolulu Hawaii 96817 —
Cotton O'Neil Clinical Research Topeka Kansas 66606 —
The Office of Dr. Claudia Martorell Springfield Massachusetts 01107 —
Saint Louis University St Louis Missouri 63104 —
Dartmouth-Hitchcock Medical Center Lebanon New Hampshire 03756-0001 —
Weill Cornell Medical Center New York New York 10021 —
Mount Sinai Medical Center New York New York 10029 —
Columbia University Medical Center New York New York 10032 —
The North Texas Research Institute Arlington Texas 76012 —
Liver Associates of Texas Houston Texas 77030 —
Liver Specialist of Texas Houston Texas 77030 —
Alamo Medical Research San Antonio Texas 78215 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 57 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT01215643, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Aug 30, 2016 · Synced Nov 6, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT01215643 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →