Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
Public ClinicalTrials.gov record NCT01435044. 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
QUANTUM: An International, Multi-center, Blinded, Randomized Study to Investigate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Following Administration of Regimens Containing PSI-352938, PSI-7977, and Ribavirin in Patients With Chronic Hepatitis C Virus (HCV) Infection
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This study was designed to assess the safety and efficacy of multiple interferon-free treatment regimens of sofosbuvir (Sovaldi™; GS-7977; PSI-7977) and GS-0938 (PSI-352938) alone and in combination, with and without ribavirin (RBV). Each regimen was to be evaluated over 12 and 24 weeks to identify the optimal duration of therapy to maximize the benefit (sustained virologic response \[SVR\]) versus risk (safety and resistance).
Study identification
- NCT ID
- NCT01435044
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 239 participants
Conditions and interventions
Conditions
Interventions
- Sofosbuvir Drug
- GS-0938 Drug
- RBV Drug
- Placebo to match sofosbuvir Drug
- Placebo to match GS-0938 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
- Sep 2011 (Type not available)
- Primary completion
- Apr 2013 (Actual)
- Completion
- May 2013 (Actual)
- Last update posted
- Feb 6, 2014
2011 – 2013
United States locations
- U.S. sites
- 42
- U.S. states
- 16
- U.S. cities
- 36
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Alabama Liver & Digestive Specialists | Montgomery | Alabama | 36116 | — |
| Not listed | Bakersfield | California | 93301 | — |
| Not listed | Coronado | California | 92118 | — |
| Not listed | La Mesa | California | 91942 | — |
| Not listed | Los Angeles | California | 90036 | — |
| CLI | Los Angeles | California | 90048 | — |
| UCSD Antiviral Research Center | San Diego | California | 92103 | — |
| eStudy Site | San Diego | California | 92120 | — |
| Medical Associates Research Group | San Diego | California | 92193 | — |
| Quest Clinical Research | San Francisco | California | 94115 | — |
| Not listed | Denver | Colorado | 80220 | — |
| Not listed | Engelwood | Colorado | 80113 | — |
| South Denver Gastroenterology | Englewood | Colorado | 80113 | — |
| Not listed | Washington D.C. | District of Columbia | 20009 | — |
| Avail Clinical Research | DeLand | Florida | 32720 | — |
| University of Florida Hepatology | Gainesville | Florida | 32610 | — |
| University of Miami Center for Liver Diseases | Miami | Florida | 33136 | — |
| Orlando Immunology Center | Orlando | Florida | 32803 | — |
| Internal Medicine Specialists | Orlando | Florida | 32806 | — |
| Miami Research Associates | South Miami | Florida | 33143 | — |
| Advanced Research Institute | Trinity | Florida | 34655 | — |
| South Florida Center of Gastroenterology | Wellington | Florida | 33414 | — |
| AIDS Research Consortium of Atlanta | Atlanta | Georgia | 30308 | — |
| Not listed | Atlanta | Georgia | 30308 | — |
| Not listed | Marietta | Georgia | 30060 | — |
| Digestive Health Services | Downers Grove | Illinois | 60515 | — |
| Investigative Clinical Research | Annapolis | Maryland | 21401 | — |
| Not listed | Baltimore | Maryland | 21229 | — |
| ID Care | Hillsborough | New Jersey | 08844 | — |
| Concorde Medical Group | New York | New York | 10016 | — |
| Mount Sinai Medical Center | New York | New York | 10029 | — |
| Ashville Gastroenterology Associates | Ashville | North Carolina | 28801 | — |
| Carolina's Center for Liver Disease | Statesville | North Carolina | 28677 | — |
| Digestive Health Specialists | Winston-Salem | North Carolina | 27103 | — |
| Not listed | Cincinnati | Ohio | — | — |
| Gastro One | Germantown | Tennessee | 38138 | — |
| Nashville Gastrointestinal Specialists | Nashville | Tennessee | 37211 | — |
| Texas Clinical Research Institute | Arlington | Texas | 76012 | — |
| Central Texas Clinical Research | Austin | Texas | 78705 | — |
| Alamo Medical Research | San Antonio | Texas | 78215 | — |
| Digestive and Liver Disease Specialists | Norfolk | Virginia | 23502 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
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 2 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT01435044, 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 Feb 6, 2014 · Synced Oct 25, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT01435044 live on ClinicalTrials.gov.