Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
QUANTUM
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
1 other identifier
interventional
239
2 countries
44
Brief Summary
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Sep 2011
44 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2011
CompletedFirst Submitted
Initial submission to the registry
September 9, 2011
CompletedFirst Posted
Study publicly available on registry
September 15, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFebruary 6, 2014
January 1, 2014
1.6 years
September 9, 2011
January 7, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12)
SVR12 was defined as HCV RNA \< LLOQ 12 weeks after the last dose of all study drugs.
Post-treatment Week 12
Secondary Outcomes (6)
Percentage of Participants Who Experienced Adverse Events
Baseline to Week 24 plus 30 days
Change from baseline in HCV RNA
Baseline to Week 12
Percentage of Participants With HCV RNA < LLOQ during treatment
Baseline to Week 12
Percentage of Participants With ALT Normalization
Baseline to post-treatment Week 4
Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug (SVR4; SVR24)
Post-treatment Weeks 4 and 24
- +1 more secondary outcomes
Study Arms (7)
SOF+RBV 12 Weeks
EXPERIMENTALParticipants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks.
SOF+RBV 24 Weeks
EXPERIMENTALParticipants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks.
GS-0938 Alone
EXPERIMENTALParticipants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks.
GS-0938+SOF
EXPERIMENTALParticipants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks.
GS-0938+SOF+RBV
EXPERIMENTALParticipants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks.
Placebo
EXPERIMENTALDeferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks.
Retreatment Group - SOF+RBV 24 Weeks
EXPERIMENTALAfter discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks.
Interventions
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
Ribavirin (RBV) tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (\< 75kg = 1000 mg and ≥ 75 kg = 1200 mg)
Placebo to match sofosbuvir administered orally once daily
Eligibility Criteria
You may qualify if:
- Chronic HCV-infection
- Naive to all HCV antiviral treatment
- Otherwise healthy patients
You may not qualify if:
- Positive test at Screening for HBsAg, anti-HBc IgM Ab, or anti-HIV Ab
- History of any other clinically significant chronic liver disease
- Medical history which the investigator considers the patient unsuitable for the study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Gilead Scienceslead
- Quintiles, Inc.collaborator
Study Sites (44)
Alabama Liver & Digestive Specialists
Montgomery, Alabama, 36116, United States
Unknown Facility
Bakersfield, California, 93301, United States
Unknown Facility
Coronado, California, 92118, United States
Unknown Facility
La Mesa, California, 91942, United States
Unknown Facility
Los Angeles, California, 90036, United States
CLI
Los Angeles, California, 90048, United States
UCSD Antiviral Research Center
San Diego, California, 92103, United States
eStudy Site
San Diego, California, 92120, United States
Medical Associates Research Group
San Diego, California, 92193, United States
Quest Clinical Research
San Francisco, California, 94115, United States
Unknown Facility
Denver, Colorado, 80220, United States
Unknown Facility
Engelwood, Colorado, 80113, United States
South Denver Gastroenterology
Englewood, Colorado, 80113, United States
Unknown Facility
Washington D.C., District of Columbia, 20009, United States
Avail Clinical Research
DeLand, Florida, 32720, United States
University of Florida Hepatology
Gainesville, Florida, 32610, United States
University of Miami Center for Liver Diseases
Miami, Florida, 33136, United States
Orlando Immunology Center
Orlando, Florida, 32803, United States
Internal Medicine Specialists
Orlando, Florida, 32806, United States
Miami Research Associates
South Miami, Florida, 33143, United States
Advanced Research Institute
Trinity, Florida, 34655, United States
South Florida Center of Gastroenterology
Wellington, Florida, 33414, United States
AIDS Research Consortium of Atlanta
Atlanta, Georgia, 30308, United States
Unknown Facility
Atlanta, Georgia, 30308, United States
Unknown Facility
Marietta, Georgia, 30060, United States
Digestive Health Services
Downers Grove, Illinois, 60515, United States
Investigative Clinical Research
Annapolis, Maryland, 21401, United States
Unknown Facility
Baltimore, Maryland, 21229, United States
ID Care
Hillsborough, New Jersey, 08844, United States
Concorde Medical Group
New York, New York, 10016, United States
Mount Sinai Medical Center
New York, New York, 10029, United States
Ashville Gastroenterology Associates
Ashville, North Carolina, 28801, United States
Carolina's Center for Liver Disease
Statesville, North Carolina, 28677, United States
Digestive Health Specialists
Winston-Salem, North Carolina, 27103, United States
Unknown Facility
Cincinnati, Ohio, United States
Gastro One
Germantown, Tennessee, 38138, United States
Nashville Gastrointestinal Specialists
Nashville, Tennessee, 37211, United States
Texas Clinical Research Institute
Arlington, Texas, 76012, United States
Central Texas Clinical Research
Austin, Texas, 78705, United States
Alamo Medical Research
San Antonio, Texas, 78215, United States
Digestive and Liver Disease Specialists
Norfolk, Virginia, 23502, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Unknown Facility
San Juan, Puerto Rico, 00909, Puerto Rico
Fundacion de Investigacion de Diego
San Juan, 00927, Puerto Rico
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Robert H. Hyland, DPhil
Gilead Sciences
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 9, 2011
First Posted
September 15, 2011
Study Start
September 1, 2011
Primary Completion
April 1, 2013
Study Completion
May 1, 2013
Last Updated
February 6, 2014
Record last verified: 2014-01