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Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection (QUANTUM)

Primary Purpose

Hepatitis C, Chronic

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Sofosbuvir
GS-0938
RBV
Placebo to match sofosbuvir
Placebo to match GS-0938
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hepatitis C, Chronic focused on measuring Hepatitis C, Chronic, HCV

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Alabama Liver & Digestive Specialists
  • CLI
  • UCSD Antiviral Research Center
  • eStudy Site
  • Medical Associates Research Group
  • Quest Clinical Research
  • South Denver Gastroenterology
  • Avail Clinical Research
  • University of Florida Hepatology
  • University of Miami Center for Liver Diseases
  • Orlando Immunology Center
  • Internal Medicine Specialists
  • Miami Research Associates
  • Advanced Research Institute
  • South Florida Center of Gastroenterology
  • AIDS Research Consortium of Atlanta
  • Digestive Health Services
  • Investigative Clinical Research
  • ID Care
  • Concorde Medical Group
  • Mount Sinai Medical Center
  • Ashville Gastroenterology Associates
  • Carolina's Center for Liver Disease
  • Digestive Health Specialists
  • Gastro One
  • Nashville Gastrointestinal Specialists
  • Texas Clinical Research Institute
  • Central Texas Clinical Research
  • Alamo Medical Research
  • Digestive and Liver Disease Specialists
  • Virginia Mason Medical Center
  • Fundacion de Investigacion de Diego

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

SOF+RBV 12 Weeks

SOF+RBV 24 Weeks

GS-0938 Alone

GS-0938+SOF

GS-0938+SOF+RBV

Placebo

Retreatment Group - SOF+RBV 24 Weeks

Arm Description

Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks.

Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks.

Participants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks.

Participants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks.

Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks.

Deferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks.

After discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants Who Experienced Adverse Events
Adverse events (AEs) were summarized across the participant population. A participant was counted once if they had a qualifying event.
Change from baseline in HCV RNA
Percentage of Participants With HCV RNA < LLOQ during treatment
Percentage of Participants With ALT Normalization
ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at a subsequent visit.
Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug (SVR4; SVR24)
SVR4 and SVR24 was defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of all study drugs, respectively.
Percentage of Participants Who Developed Resistance to Sofosbuvir

Full Information

First Posted
September 9, 2011
Last Updated
January 7, 2014
Sponsor
Gilead Sciences
Collaborators
Quintiles, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01435044
Brief Title
Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection
Acronym
QUANTUM
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
September 2011 (undefined)
Primary Completion Date
April 2013 (Actual)
Study Completion Date
May 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
Collaborators
Quintiles, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Chronic
Keywords
Hepatitis C, Chronic, HCV

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SOF+RBV 12 Weeks
Arm Type
Experimental
Arm Description
Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks.
Arm Title
SOF+RBV 24 Weeks
Arm Type
Experimental
Arm Description
Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks.
Arm Title
GS-0938 Alone
Arm Type
Experimental
Arm Description
Participants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks.
Arm Title
GS-0938+SOF
Arm Type
Experimental
Arm Description
Participants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks.
Arm Title
GS-0938+SOF+RBV
Arm Type
Experimental
Arm Description
Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks.
Arm Title
Placebo
Arm Type
Experimental
Arm Description
Deferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks.
Arm Title
Retreatment Group - SOF+RBV 24 Weeks
Arm Type
Experimental
Arm Description
After discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Sofosbuvir
Other Intervention Name(s)
Sovaldi™, GS-7977, PSI-7977
Intervention Description
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Intervention Type
Drug
Intervention Name(s)
GS-0938
Other Intervention Name(s)
PSI-352938
Intervention Description
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
Intervention Type
Drug
Intervention Name(s)
RBV
Other Intervention Name(s)
Ribasphere®
Intervention Description
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)
Intervention Type
Drug
Intervention Name(s)
Placebo to match sofosbuvir
Intervention Description
Placebo to match sofosbuvir administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo to match GS-0938
Intervention Description
Placebo to match GS-0938 administered orally once daily
Primary Outcome Measure Information:
Title
Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12)
Description
SVR12 was defined as HCV RNA < LLOQ 12 weeks after the last dose of all study drugs.
Time Frame
Post-treatment Week 12
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Experienced Adverse Events
Description
Adverse events (AEs) were summarized across the participant population. A participant was counted once if they had a qualifying event.
Time Frame
Baseline to Week 24 plus 30 days
Title
Change from baseline in HCV RNA
Time Frame
Baseline to Week 12
Title
Percentage of Participants With HCV RNA < LLOQ during treatment
Time Frame
Baseline to Week 12
Title
Percentage of Participants With ALT Normalization
Description
ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at a subsequent visit.
Time Frame
Baseline to post-treatment Week 4
Title
Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug (SVR4; SVR24)
Description
SVR4 and SVR24 was defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of all study drugs, respectively.
Time Frame
Post-treatment Weeks 4 and 24
Title
Percentage of Participants Who Developed Resistance to Sofosbuvir
Time Frame
Baseline to Week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert H. Hyland, DPhil
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Alabama Liver & Digestive Specialists
City
Montgomery
State/Province
Alabama
ZIP/Postal Code
36116
Country
United States
City
Bakersfield
State/Province
California
ZIP/Postal Code
93301
Country
United States
City
Coronado
State/Province
California
ZIP/Postal Code
92118
Country
United States
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
CLI
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
UCSD Antiviral Research Center
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
eStudy Site
City
San Diego
State/Province
California
ZIP/Postal Code
92120
Country
United States
Facility Name
Medical Associates Research Group
City
San Diego
State/Province
California
ZIP/Postal Code
92193
Country
United States
Facility Name
Quest Clinical Research
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
City
Denver
State/Province
Colorado
ZIP/Postal Code
80220
Country
United States
City
Engelwood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
Facility Name
South Denver Gastroenterology
City
Englewood
State/Province
Colorado
ZIP/Postal Code
80113
Country
United States
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20009
Country
United States
Facility Name
Avail Clinical Research
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
University of Florida Hepatology
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
University of Miami Center for Liver Diseases
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Orlando Immunology Center
City
Orlando
State/Province
Florida
ZIP/Postal Code
32803
Country
United States
Facility Name
Internal Medicine Specialists
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Miami Research Associates
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Advanced Research Institute
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
South Florida Center of Gastroenterology
City
Wellington
State/Province
Florida
ZIP/Postal Code
33414
Country
United States
Facility Name
AIDS Research Consortium of Atlanta
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30308
Country
United States
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Digestive Health Services
City
Downers Grove
State/Province
Illinois
ZIP/Postal Code
60515
Country
United States
Facility Name
Investigative Clinical Research
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21229
Country
United States
Facility Name
ID Care
City
Hillsborough
State/Province
New Jersey
ZIP/Postal Code
08844
Country
United States
Facility Name
Concorde Medical Group
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Facility Name
Mount Sinai Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Ashville Gastroenterology Associates
City
Ashville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Carolina's Center for Liver Disease
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28677
Country
United States
Facility Name
Digestive Health Specialists
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
City
Cincinnati
State/Province
Ohio
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Nashville Gastrointestinal Specialists
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Texas Clinical Research Institute
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Central Texas Clinical Research
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Alamo Medical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
Facility Name
Digestive and Liver Disease Specialists
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Virginia Mason Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
City
San Juan
ZIP/Postal Code
00909
Country
Puerto Rico
Facility Name
Fundacion de Investigacion de Diego
City
San Juan
ZIP/Postal Code
00927
Country
Puerto Rico

12. IPD Sharing Statement

Learn more about this trial

Safety Study of Regimens of Sofosbuvir, GS-0938, and Ribavirin in Patients With Chronic Hepatitis C Infection

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