Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants
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.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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
- Enrollment
- 340 participants
Conditions and interventions
Conditions
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
- Sep 30, 2010
- Primary completion
- Apr 30, 2012
- Completion
- Apr 30, 2012
- Last update posted
- Aug 29, 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 29, 2016 · Synced Sep 20, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01215643 live on ClinicalTrials.gov.