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
Public ClinicalTrials.gov record NCT01183169. 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, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT01183169
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 459 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
- Aug 2010 (Type not available)
- Primary completion
- May 2013 (Actual)
- Completion
- May 2013 (Actual)
- Last update posted
- Aug 25, 2016
2010 – 2013
United States locations
- U.S. sites
- 18
- U.S. states
- 9
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Novartis Investigative Site | San Diego | California | 92101 | — |
| Novartis Investigative Site | San Diego | California | 92115 | — |
| Novartis Investigative Site | Ventura | California | 93003 | — |
| Novartis Investigative Site | Bradenton | Florida | 34209 | — |
| Novartis Investigative Site | Orlando | Florida | 32804 | — |
| Novartis Investigative Site | Tampa | Florida | 33607 | — |
| Novartis Investigative Site | Honolulu | Hawaii | 96814 | — |
| Novartis Investigative Site | Honolulu | Hawaii | 96817 | — |
| Novartis Investigative Site | Springfield | Illinois | 62703 | — |
| Novartis Investigative Site | Topeka | Kansas | 66606 | — |
| Novartis Investigative Site | Springfield | Massachusetts | 01107 | — |
| Novartis Investigative Site | Egg Harbor Twp | New Jersey | 08234 | — |
| Novartis Investigative Site | Brooklyn | New York | 11230 | — |
| Novartis Investigative Site | New York | New York | 10021 | — |
| Novartis Investigative Site | Arlington | Texas | 76012 | — |
| Novartis Investigative Site | Dallas | Texas | 75246-2096 | — |
| Novartis Investigative Site | Houston | Texas | 77030 | — |
| Novartis Investigative Site | 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 NCT01183169, 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 25, 2016 · Synced Oct 17, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01183169 live on ClinicalTrials.gov.