Sofosbuvir in Combination With Pegylated Interferon and Ribavirin and in Treatment-Naive Hepatitis C-infected Patients
Public ClinicalTrials.gov record NCT01188772. 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 Multi-center, Placebo-Controlled, Dose Ranging Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Oral Administration of PSI-7977 in Combination With Pegylated Interferon and Ribavirin in Treatment-Naïve Patients With Chronic HCV Infection Genotype 1, and an Open Label Assessment of PSI-7977 in Patients With HCV Genotypes 2 or 3
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Genotype 1: Participants with genotype 1 hepatitis C (HCV) infection were randomized to receive sofosbuvir (GS-7977; PSI-7977) 200 mg or 400 mg, or matching placebo, plus pegylated interferon alfa 2a (PEG) and ribavirin (RBV) for 12 weeks, followed by PEG+RBV for an up to an additional 36 weeks. Randomization was stratified by IL28B status (CC, CT, TT) and HCV RNA level (\< 800,000 IU/ml or ≥ 800,000 IU/ml) at baseline. Participants were randomized in a 2:2:1 manner; those who achieved an extended rapid virologic response (eRVR) (HCV RNA \< lower limit of detection \[15 IU/mL\] from Weeks 4 through 12) received an additional 12 weeks of PEG+RBV. Subjects not achieving eRVR received an additional 36 weeks of PEG+RBV. Genotype 2 and 3: Participants with genotype 2 or 3 hepatitis C (HCV) received sofosbuvir 400 mg plus PEG+RBV for 12 weeks.
Study identification
- NCT ID
- NCT01188772
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 147 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
- Apr 2011 (Actual)
- Completion
- May 2012 (Actual)
- Last update posted
- Apr 21, 2014
2010 – 2012
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Liver and Digestive Specialists | Montgomery | Alabama | — | — |
| Advanced Clinical Research Institute | Anaheim | California | — | — |
| SCTI Research Foundation | Coronado | California | — | — |
| Cedars Sinai Medical Center | Los Angeles | California | — | — |
| Dr. Jay Lalezari | San Francisco | California | — | — |
| Dr. Natalie Bzowej | San Francisco | California | — | — |
| Dr. David Nelson | Gainesville | Florida | — | — |
| Orlando Immunology Center | Orlando | Florida | — | — |
| Gastrointestinal Specialists of Georgia | Marietta | Georgia | — | — |
| University of Chicago | Chicago | Illinois | — | — |
| Dr. Mark Sulkowski | Lutherville | Maryland | — | — |
| Liver Research Center Beth Israel Deaconess Medical Center | Boston | Massachusetts | — | — |
| Kansas City Gastroenterology and Hepatology | Kansas City | Missouri | — | — |
| Dr. Bruce Bacon | St Louis | Missouri | — | — |
| North Shore University Hospital | Manhasset | New York | — | — |
| Dr. Ira Jacobson | New York | New York | — | — |
| Mount Sinai School of Medicine | New York | New York | — | — |
| Dr. Jama Darling | Chapel Hill | North Carolina | — | — |
| Dr. Raj Reddy | Philadelphia | Pennsylvania | — | — |
| Columbia Gastroenterology and Liver Associates | Columbia | South Carolina | — | — |
| Dr. Eric Lawitz | San Antonio | Texas | — | — |
| Digestive Disease Institute Virginia Mason Medical Center | Seattle | Washington | — | — |
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 NCT01188772, 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 Apr 21, 2014 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01188772 live on ClinicalTrials.gov.