Phase III Hallmark DUAL: ASV+DCV (Nulls/Partials, Intolerants/Ineligibles. Naives)
Public ClinicalTrials.gov record NCT01581203. 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 Study With Asunaprevir and Daclatasvir (DUAL) for Null or Partial Responders to Peginterferon Alfa and Ribavirin (P/R), Intolerant or Ineligible to P/R Subjects and Treatment-Naive Subjects With Chronic Hepatitis C Genotype 1b Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of this study is to estimate efficacy, as determined by the proportion of subjects with Sustained virologic response at post-treatment Week 12 (SVR12), defined as Hepatitis C virus (HCV) Ribonucleic acid (RNA) \< Limit of quantitation (LOQ) at post-treatment Week 12, for subjects who are prior null or partial responders to P/R or who are treatment-naive.
Study identification
- NCT ID
- NCT01581203
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 748 participants
Conditions and interventions
Conditions
Interventions
- Asunaprevir (ASV) Drug
- Daclatasvir (DCV) Drug
- Pegylated-interferon alfa 2a (PegIFN) Drug
- Ribavirin (RBV) Drug
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
- Apr 30, 2012
- Primary completion
- Sep 30, 2013
- Completion
- Aug 31, 2014
- Last update posted
- Oct 8, 2015
2012 – 2014
United States locations
- U.S. sites
- 18
- U.S. states
- 12
- U.S. cities
- 17
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| The Health Care Authority For Baptist Health | Montgomery | Alabama | 36116 | — |
| Scripps Clinic | La Jolla | California | 92037 | — |
| Scpmg/ Kaiser Permanente Los Angeles Medical Center | Los Angeles | California | 90027 | — |
| University Of Colorado Denver And Hospital | Aurora | Colorado | 80045 | — |
| Uf Hepatology Research At Ctrb | Gainesville | Florida | 32610 | — |
| Johns Hopkins Medical Institutions | Lutherville | Maryland | 21093 | — |
| Beth Israel Deaconess Medical Center | Boston | Massachusetts | 02215 | — |
| Henry Ford Health System | Detroit | Michigan | 48202 | — |
| Washington University School Of Medicine | St Louis | Missouri | 63110 | — |
| North Shore-Long Island Jewish Health System | Manhasset | New York | 11030 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| University Of North Carolina At Chapel Hill School Of Med | Chapel Hill | North Carolina | 27599 | — |
| Carolinas Medical Center | Charlotte | North Carolina | 28204 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| Baylor College Of Medicine | Houston | Texas | 77030 | — |
| Vamc | Houston | Texas | 77030 | — |
| Alamo Medical Research | San Antonio | Texas | 78215 | — |
| Dean Clinic | Madison | Wisconsin | 53715 | — |
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 98 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01581203, 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 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01581203 live on ClinicalTrials.gov.