AzTrials
AzTrials

Hepatitis C, ChronicPhase 2QUANTUMNCT01435044

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

A Phase 2 study testing Sofosbuvir, GS-0938 and RBV in people with Hepatitis C, Chronic, run by Gilead Sciences at 44 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hepatitis C, Chronic
What is being tested?
Sofosbuvir, GS-0938 and RBV
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
239 participants
Where
44 sitesin 2 countries
Study dates
Sep 2011to May 2013
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

44 sites in 2 countries.

44 sites in 2 countries

United States42 sites

  • Investigative Clinical Research

    Annapolis, Maryland, 21401

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Ashville Gastroenterology Associates

    Ashville, North Carolina, 28801

  • AIDS Research Consortium of Atlanta

    Atlanta, Georgia, 30308

  • Study site

    Atlanta, Georgia, 30308

  • Central Texas Clinical Research

    Austin, Texas, 78705

  • Study site

    Bakersfield, California, 93301

  • Study site

    Baltimore, Maryland, 21229

  • Study site

    Cincinnati, Ohio

  • Study site

    Coronado, California, 92118

  • Avail Clinical Research

    DeLand, Florida, 32720

  • Study site

    Denver, Colorado, 80220

  • Digestive Health Services

    Downers Grove, Illinois, 60515

  • Study site

    Engelwood, Colorado, 80113

  • South Denver Gastroenterology

    Englewood, Colorado, 80113

  • University of Florida Hepatology

    Gainesville, Florida, 32610

  • Gastro One

    Germantown, Tennessee, 38138

  • ID Care

    Hillsborough, New Jersey, 08844

  • Study site

    La Mesa, California, 91942

  • Study site

    Los Angeles, California, 90036

  • CLI

    Los Angeles, California, 90048

  • Study site

    Marietta, Georgia, 30060

  • University of Miami Center for Liver Diseases

    Miami, Florida, 33136

  • Alabama Liver & Digestive Specialists

    Montgomery, Alabama, 36116

  • Nashville Gastrointestinal Specialists

    Nashville, Tennessee, 37211

  • Concorde Medical Group

    New York, New York, 10016

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Digestive and Liver Disease Specialists

    Norfolk, Virginia, 23502

  • Orlando Immunology Center

    Orlando, Florida, 32803

  • Internal Medicine Specialists

    Orlando, Florida, 32806

  • Alamo Medical Research

    San Antonio, Texas, 78215

  • 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

  • Virginia Mason Medical Center

    Seattle, Washington, 98101

  • Miami Research Associates

    South Miami, Florida, 33143

  • Carolina's Center for Liver Disease

    Statesville, North Carolina, 28677

  • Advanced Research Institute

    Trinity, Florida, 34655

  • Study site

    Washington D.C., District of Columbia, 20009

  • South Florida Center of Gastroenterology

    Wellington, Florida, 33414

  • Digestive Health Specialists

    Winston-Salem, North Carolina, 27103

Other trials in United States

Puerto Rico2 sites

  • Study site

    San Juan, Puerto Rico, 00909

  • Fundacion de Investigacion de Diego

    San Juan, 00927

Other trials in Puerto Rico

About this study

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

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).

Being tested
Sofosbuvir, GS-0938, RBV, Placebo to match sofosbuvir, Placebo to match GS-0938
Keywords
Hepatitis C, Chronic, HCV
Medical subject headings
Hepatitis C, Chronic, Hepatitis C, Bronchiolitis Obliterans Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SofosbuvirDrug

    Also called Sovaldi™, GS-7977, PSI-7977

    Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily

  • GS-0938Drug

    Also called PSI-352938

    GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily

  • RBVDrug

    Also called Ribasphere®

    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 sofosbuvirDrug

    Placebo to match sofosbuvir administered orally once daily

  • Placebo to match GS-0938Drug

    Placebo to match GS-0938 administered orally once daily

Study groups in NCT01435044
Study groupRoleWhat they receive
SOF+RBV 12 WeeksExperimentalParticipants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks.
Receives: Drug: Sofosbuvir; Drug: RBV
SOF+RBV 24 WeeksExperimentalParticipants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks.
Receives: Drug: Sofosbuvir; Drug: RBV
GS-0938 AloneExperimentalParticipants were randomized to receive GS-0938 plus placebo to match sofosbuvir for up to 24 weeks.
Receives: Drug: GS-0938; Drug: Placebo to match sofosbuvir
GS-0938+SOFExperimentalParticipants were randomized to receive GS-0938 plus sofosbuvir for up to 24 weeks.
Receives: Drug: Sofosbuvir; Drug: GS-0938
GS-0938+SOF+RBVExperimentalParticipants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks.
Receives: Drug: Sofosbuvir; Drug: GS-0938; Drug: RBV
PlaceboExperimentalDeferred start group: Participants were randomized to receive placebo to match GS-0938 plus placebo to match sofosbuvir for 24 Weeks.
Receives: Drug: Placebo to match sofosbuvir; Drug: Placebo to match GS-0938
Retreatment Group - SOF+RBV 24 WeeksExperimentalAfter discontinuing a regimen containing GS-0938, participants received sofosbuvir plus RBV for up to 24 weeks.
Receives: Drug: Sofosbuvir; Drug: RBV

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Post-treatment Week 12

Secondary outcomes (6)

  1. 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.

    Measured: Baseline to Week 24 plus 30 days

  2. Change from baseline in HCV RNA

    Measured: Baseline to Week 12

  3. Percentage of Participants With HCV RNA < LLOQ during treatment

    Measured: Baseline to Week 12

  4. Percentage of Participants With ALT Normalization

    ALT normalization was defined as ALT > ULN at baseline and ALT ≤ ULN at a subsequent visit.

    Measured: Baseline to post-treatment Week 4

  5. 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.

    Measured: Post-treatment Weeks 4 and 24

  6. Percentage of Participants Who Developed Resistance to Sofosbuvir

    Measured: Baseline to Week 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionApr 2013
  4. Study completionMay 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
239 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01435044
Sponsor's protocol ID
P2938-0721
Acronym
QUANTUM
Status last verified
Jan 2014
First submitted
9 Sep 2011
Last updated
6 Feb 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Sofosbuvir, GS-0938 and RBV in people with Hepatitis C, Chronic, run by Gilead Sciences at 44 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 44 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12) (time frame: Post-treatment Week 12). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01435044.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2014.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in