Study to Determine the Safety and Effectiveness of Antiviral Combination Therapy to Treat Hepatitis C Virus (HCV) in Patients Who Have Previously Not Received the Standard of Care
Public ClinicalTrials.gov record NCT01359644. 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
Parallel, Open-Label, Randomized Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of PSI-7977 in Combination With BMS-790052 With or Without Ribavirin in Treatment Naive Subjects Chronically Infected With Hepatitis C Virus Genotypes 1, 2, or 3
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
The purpose of the study is to determine whether therapy with the combination of PSI-7977 and daclatasvir (BMS-790052) with or without ribavirin is effective in treating hepatitis C virus (HCV) infection when given for 12 or 24 weeks as measured by sustained virologic response with undetectable HCV RNA 12 weeks post treatment
Study identification
- NCT ID
- NCT01359644
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 350 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
- May 31, 2011
- Primary completion
- Dec 31, 2012
- Completion
- Sep 30, 2013
- Last update posted
- Oct 22, 2015
2011 – 2013
United States locations
- U.S. sites
- 17
- U.S. states
- 11
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Southern California Liver Centers | Coronado | California | 92118 | — |
| Research And Education, Inc. | San Diego | California | 92105 | — |
| University Of Colorado Denver & Hospital | Aurora | Colorado | 80045 | — |
| University Of Florida Hepatology | Gainesville | Florida | 32610 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Miami Research Associates | South Miami | Florida | 33143 | — |
| Mercy Medical Center | Baltimore | Maryland | 21202 | — |
| Johns Hopkins University | Lutherville | Maryland | 21093 | — |
| University Of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| Weill Cornell Medical College | New York | New York | 10021 | — |
| Bronx Va Medical Center 3c Sub-J | The Bronx | New York | 10468 | — |
| Options Health Research, Llc | Tulsa | Oklahoma | 74104 | — |
| Healthcare Research Consultants | Tulsa | Oklahoma | 74135 | — |
| University Of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Alamo Medical Research | San Antonio | Texas | 78215 | — |
| Metropolitan Research | Annandale | Virginia | 22003 | — |
| 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 1 non-U.S. site.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01359644, 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 22, 2015 · Synced Sep 2, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT01359644 live on ClinicalTrials.gov.