Safety and Efficacy Study of Pegylated Interferon Lambda With and Without Daclatasvir, Compared to Pegylated Interferon Alfa, Plus Ribavirin in Subjects With Hepatitis C Genotype 2 and 3
Public ClinicalTrials.gov record NCT01616524. 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 Phase 3, Randomized, Double-Blind, Controlled Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a, With and Without Daclatasvir, Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naïve Genotype 2 and 3 Chronic Hepatitis C Subjects
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to determine if 24 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and 12 weeks of treatment with Pegylated Interferon Lambda plus Ribavirin and Daclatasvir will be safe and effective for treatment of hepatitis C compared to 24 weeks of treatment with Pegylated Interferon Alfa-2a plus Ribavirin
Study identification
- NCT ID
- NCT01616524
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 880 participants
Conditions and interventions
Conditions
Interventions
- Pegylated interferon lambda (pegIFNλ) Biological
- Pegylated interferon alfa-2a (pegIFNα-2a) Biological
- Ribavirin Drug
- Daclatasvir Drug
- Placebo matching Daclatasvir Drug
Biological · Drug
Eligibility (public fields only)
- Age range
- 18 Years and older
- 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
- Jun 30, 2012
- Primary completion
- May 31, 2014
- Completion
- Aug 31, 2014
- Last update posted
- Oct 8, 2015
2012 – 2014
United States locations
- U.S. sites
- 18
- U.S. states
- 13
- U.S. cities
- 15
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mayo Clinic Arizona | Phoenix | Arizona | 85054 | — |
| Precision Research Institute, Llc | San Diego | California | 92114 | — |
| Medical Associates Research Group | San Diego | California | 92123 | — |
| University Of California, San Francisco/Sf General Hospital | San Francisco | California | 94110 | — |
| Kaiser Permanente Medical Center | San Francisco | California | 94118 | — |
| Yale University School Of Medicine | New Haven | Connecticut | 06510 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Orlando Infectious Disease Center | Orlando | Florida | 32806 | — |
| Gastrointestinal Specialists Of Georgia | Marietta | Georgia | 30060 | — |
| The Queen'S Liver Center | Honolulu | Hawaii | 96813 | — |
| Henry Ford Hospital | Detroit | Michigan | 48202 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | — |
| Consultants For Clinical Research | Cincinnati | Ohio | 45249 | — |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | — |
| University Of Pittsburgh Medical Center, Ctr For Liver Diseases | Pittsburgh | Pennsylvania | 15213 | — |
| Texas Clinical Research Institute, Llc | Arlington | Texas | 76012 | — |
| St. Luke'S Episcopal Hospital - Baylor College Of Medicine | Houston | Texas | 77030 | — |
| Clinical Research Centers Of America | Murray | Utah | 84123 | — |
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 106 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01616524, 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 Oct 8, 2015 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01616524 live on ClinicalTrials.gov.