Clinical trial NCT01435044: Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Hepatitis C, Chronic
Keywords: Hepatitis C
Chronic
HCV
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Quintiles, Inc.
First posted: 2011-09-15
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: Inclusion Criteria:

* Chronic HCV-infection
* Naive to all HCV antiviral treatment
* Otherwise healthy patients

Exclusion Criteria:

* 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

Primary outcomes:
measure: Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12)
timeFrame: Post-treatment Week 12
Secondary outcomes:
measure: Percentage of Participants Who Experienced Adverse Events
timeFrame: Baseline to Week 24 plus 30 days
measure: Change from baseline in HCV RNA
timeFrame: Baseline to Week 12
measure: Percentage of Participants With HCV RNA < LLOQ during treatment
timeFrame: Baseline to Week 12
measure: Percentage of Participants With ALT Normalization
timeFrame: Baseline to post-treatment Week 4
measure: Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug (SVR4; SVR24)
timeFrame: Post-treatment Weeks 4 and 24
measure: Percentage of Participants Who Developed Resistance to Sofosbuvir
timeFrame: Baseline to Week 24
Other outcomes:
Locations:
city: Montgomery
country: United States
facility: Alabama Liver & Digestive Specialists
state: Alabama
city: Bakersfield
country: United States
state: California
city: Coronado
country: United States
state: California
city: La Mesa
country: United States
state: California
city: Los Angeles
country: United States
state: California
city: Los Angeles
country: United States
facility: CLI
state: California
city: San Diego
country: United States
facility: UCSD Antiviral Research Center
state: California
city: San Diego
country: United States
facility: eStudy Site
state: California
city: San Diego
country: United States
facility: Medical Associates Research Group
state: California
city: San Francisco
country: United States
facility: Quest Clinical Research
state: California
city: Denver
country: United States
state: Colorado
city: Engelwood
country: United States
state: Colorado
city: Englewood
country: United States
facility: South Denver Gastroenterology
state: Colorado
city: Washington
country: United States
state: District of Columbia
city: Deland
country: United States
facility: Avail Clinical Research
state: Florida
city: Gainesville
country: United States
facility: University of Florida Hepatology
state: Florida
city: Miami
country: United States
facility: University of Miami Center for Liver Diseases
state: Florida
city: Orlando
country: United States
facility: Orlando Immunology Center
state: Florida
city: Orlando
country: United States
facility: Internal Medicine Specialists
state: Florida
city: South Miami
country: United States
facility: Miami Research Associates
state: Florida
city: Trinity
country: United States
facility: Advanced Research Institute
state: Florida
city: Wellington
country: United States
facility: South Florida Center of Gastroenterology
state: Florida
city: Atlanta
country: United States
facility: AIDS Research Consortium of Atlanta
state: Georgia
city: Atlanta
country: United States
state: Georgia
city: Marietta
country: United States
state: Georgia
city: Downers Grove
country: United States
facility: Digestive Health Services
state: Illinois
city: Annapolis
country: United States
facility: Investigative Clinical Research
state: Maryland
city: Baltimore
country: United States
state: Maryland
city: Hillsborough
country: United States
facility: ID Care
state: New Jersey
city: New York
country: United States
facility: Concorde Medical Group
state: New York
city: New York
country: United States
facility: Mount Sinai Medical Center
state: New York
city: Ashville
country: United States
facility: Ashville Gastroenterology Associates
state: North Carolina
city: Statesville
country: United States
facility: Carolina's Center for Liver Disease
state: North Carolina
city: Winston-Salem
country: United States
facility: Digestive Health Specialists
state: North Carolina
city: Cincinnati
country: United States
state: Ohio
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Nashville Gastrointestinal Specialists
state: Tennessee
city: Arlington
country: United States
facility: Texas Clinical Research Institute
state: Texas
city: Austin
country: United States
facility: Central Texas Clinical Research
state: Texas
city: San Antonio
country: United States
facility: Alamo Medical Research
state: Texas
city: Norfolk
country: United States
facility: Digestive and Liver Disease Specialists
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Medical Center
state: Washington
city: San Juan
country: Puerto Rico
city: San Juan
country: Puerto Rico
facility: Fundacion de Investigacion de Diego
Study officials:
affiliation: Gilead Sciences
name: Robert H. Hyland, DPhil
role: STUDY_DIRECTOR
References: