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

This study has been completed.
Sponsor:
Collaborator:
Quintiles
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01435044
First received: September 9, 2011
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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).


Condition Intervention Phase
Hepatitis C, Chronic
Drug: Sofosbuvir
Drug: GS-0938
Drug: RBV
Drug: Placebo to match sofosbuvir
Drug: Placebo to match GS-0938
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Percentage of participants with sustained virologic response (SVR) 12 weeks after discontinuation of study drug (SVR12) [ Time Frame: Post-treatment Week 12 ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 24 plus 30 days ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With HCV RNA < LLOQ during treatment [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Percentage of Participants With ALT Normalization [ Time Frame: Baseline to post-treatment Week 4 ] [ Designated as safety issue: Yes ]
    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) [ Time Frame: Post-treatment Weeks 4 and 24 ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Baseline to Week 24 ] [ Designated as safety issue: No ]

Enrollment: 239
Study Start Date: September 2011
Study Completion Date: May 2013
Primary Completion Date: April 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOF+RBV 12 Weeks
Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 12 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Other Names:
  • Sovaldi™
  • GS-7977
  • PSI-7977
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 Name: Ribasphere®
Experimental: SOF+RBV 24 Weeks
Participants were randomized to receive sofosbuvir plus RBV plus placebo to match GS-0938 for 24 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Other Names:
  • Sovaldi™
  • GS-7977
  • PSI-7977
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 Name: Ribasphere®
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 Name: 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:
  • Sovaldi™
  • GS-7977
  • PSI-7977
Drug: GS-0938
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
Other Name: PSI-352938
Experimental: GS-0938+SOF+RBV
Participants were randomized to receive GS-0938 plus sofosbuvir plus RBV for up to 24 weeks.
Drug: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Other Names:
  • Sovaldi™
  • GS-7977
  • PSI-7977
Drug: GS-0938
GS-0938 300 mg (3 × 100 mg tablets) administered orally once daily
Other Name: PSI-352938
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 Name: Ribasphere®
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: Sofosbuvir
Sofosbuvir 400 mg (2 × 200 mg tablets) administered orally once daily
Other Names:
  • Sovaldi™
  • GS-7977
  • PSI-7977
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 Name: Ribasphere®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01435044

  Show 44 Study Locations
Sponsors and Collaborators
Gilead Sciences
Quintiles
Investigators
Study Director: Robert H. Hyland, DPhil Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01435044     History of Changes
Other Study ID Numbers: P2938-0721
Study First Received: September 9, 2011
Last Updated: January 7, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Hepatitis C
Chronic
HCV

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis C
Hepatitis, Chronic
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Ribavirin
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 30, 2014