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

January 7, 2014 updated by: Gilead Sciences

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

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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
239

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00927
        • Fundacion De Investigacion de Diego
      • San Juan, Puerto Rico, 00909
  • United States
    • Alabama
      • Montgomery, Alabama, United States, 36116
        • Alabama Liver & Digestive Specialists
    • California
      • Bakersfield, California, United States, 93301
      • Coronado, California, United States, 92118
      • La Mesa, California, United States, 91942
      • Los Angeles, California, United States, 90036
      • Los Angeles, California, United States, 90048
        • CLI
      • San Diego, California, United States, 92103
        • UCSD Antiviral Research Center
      • San Diego, California, United States, 92120
        • eStudy Site
      • San Diego, California, United States, 92193
        • Medical Associates Research Group
      • San Francisco, California, United States, 94115
        • Quest Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80220
      • Engelwood, Colorado, United States, 80113
      • Englewood, Colorado, United States, 80113
        • South Denver Gastroenterology
    • District of Columbia
      • Washington, District of Columbia, United States, 20009
    • Florida
      • Deland, Florida, United States, 32720
        • Avail Clinical Research
      • Gainesville, Florida, United States, 32610
        • University Of Florida Hepatology
      • Miami, Florida, United States, 33136
        • University of Miami Center for Liver Diseases
      • Orlando, Florida, United States, 32803
        • Orlando Immunology Center
      • Orlando, Florida, United States, 32806
        • Internal Medicine Specialists
      • South Miami, Florida, United States, 33143
        • Miami Research Associates
      • Trinity, Florida, United States, 34655
        • Advanced Research Institute
      • Wellington, Florida, United States, 33414
        • South Florida Center of Gastroenterology
    • Georgia
      • Atlanta, Georgia, United States, 30308
      • Atlanta, Georgia, United States, 30308
        • AIDS Research Consortium of Atlanta
      • Marietta, Georgia, United States, 30060
    • Illinois
      • Downers Grove, Illinois, United States, 60515
        • Digestive Health Services
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Investigative Clinical Research
      • Baltimore, Maryland, United States, 21229
    • New Jersey
      • Hillsborough, New Jersey, United States, 08844
        • ID care
    • New York
      • New York, New York, United States, 10029
        • Mount Sinai Medical Center
      • New York, New York, United States, 10016
        • Concorde Medical Group
    • North Carolina
      • Ashville, North Carolina, United States, 28801
        • Ashville Gastroenterology Associates
      • Statesville, North Carolina, United States, 28677
        • Carolina'S Center For Liver Disease
      • Winston-Salem, North Carolina, United States, 27103
        • Digestive Health Specialists
    • Ohio
      • Cincinnati, Ohio, United States
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Nashville, Tennessee, United States, 37211
        • Nashville Gastrointestinal Specialists
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute
      • Austin, Texas, United States, 78705
        • Central Texas Clinical Research
      • San Antonio, Texas, United States, 78215
        • Alamo Medical Research
    • Virginia
      • Norfolk, Virginia, United States, 23502
        • Digestive and Liver Disease Specialists
    • Washington
      • Seattle, Washington, United States, 98101
        • Virginia Mason Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: SOF+RBV 12 Weeks
Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks.
Drug: RBV
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)
Other Names:
  • Ribasphere®
Drug: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi™
Experimental: SOF+RBV 24 Weeks
Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks.
Drug: RBV
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)
Other Names:
  • Ribasphere®
Drug: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi™
Experimental: GS-0938 Alone
Participants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks.
Drug: GS-0938
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
Other Names:
  • PSI-352938
Drug: Placebo to match sofosbuvir
Placebo to match sofosbuvir administered orally once daily
Experimental: GS-0938+SOF
Participants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi™
Drug: GS-0938
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
Other Names:
  • PSI-352938
Experimental: GS-0938+SOF+RBV
Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks.
Drug: RBV
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)
Other Names:
  • Ribasphere®
Drug: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi™
Drug: GS-0938
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
Other Names:
  • PSI-352938
Experimental: Placebo
Deferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks.
Drug: Placebo to match sofosbuvir
Placebo to match sofosbuvir administered orally once daily
Drug: Placebo to match GS-0938
Placebo to match GS-0938 administered orally once daily
Experimental: Retreatment Group - SOF+RBV 24 Weeks
After discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks.
Drug: RBV
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)
Other Names:
  • Ribasphere®
Drug: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Other Names:
  • GS-7977
  • PSI-7977
  • Sovaldi™

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12)
Time Frame: Post-treatment Week 12
SVR12 was defined as HCV RNA < LLOQ 12 weeks after the last dose of all study drugs.
Post-treatment Week 12

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Experienced Adverse Events
Time Frame: Baseline to Week 24 plus 30 days
Adverse events (AEs) were summarized across the participant population. A participant was counted once if they had a qualifying event.
Baseline to Week 24 plus 30 days
Change from baseline in HCV RNA
Time Frame: Baseline to Week 12
Baseline to Week 12
Percentage of Participants With HCV RNA < LLOQ during treatment
Time Frame: Baseline to Week 12
Baseline to Week 12
Percentage of Participants With ALT Normalization
Time Frame: Baseline to post-treatment Week 4
ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at a subsequent visit.
Baseline to post-treatment Week 4
Percentage of participants with SVR at 4 and 24 weeks after discontinuation of study drug (SVR4; SVR24)
Time Frame: Post-treatment Weeks 4 and 24
SVR4 and SVR24 was defined as HCV RNA < LLOQ 4 and 24 weeks after the last dose of all study drugs, respectively.
Post-treatment Weeks 4 and 24
Percentage of Participants Who Developed Resistance to Sofosbuvir
Time Frame: Baseline to Week 24
Baseline to Week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Gilead Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Quintiles, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2013

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 1, 2013

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 9, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 15, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 6, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 7, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • P2938-0721

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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