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Completed

NCT Number: NCT01435044

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

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Key information

Conditions

Hepatitis C, Chronic Blood-Borne Infections Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Graft vs Host Disease Hepatitis Hepatitis C Hepatitis, Chronic Hepatitis, Viral, Human Immune System Diseases Infections Liver Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Respiratory Tract Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

San Juan, Puerto Rico

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Sofosbuvir

Drug

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

Other names: Sovaldi™, GS-7977, PSI-7977

GS-0938

Drug

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

Other names: PSI-352938

RBV

Drug

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®

Placebo to match sofosbuvir

Drug

Placebo to match sofosbuvir administered orally once daily

Placebo to match GS-0938

Drug

Placebo to match GS-0938 administered orally once daily

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. Change from baseline in HCV RNA

    Time frame: Baseline to Week 12

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

    Time frame: Baseline to Week 12

  4. 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.

  5. 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.

  6. Percentage of Participants Who Developed Resistance to Sofosbuvir

    Time frame: Baseline to Week 24

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Collaborators

  • Quintiles, Inc.

Registry information

Official study 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

Acronym: QUANTUM

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Sep 15, 2011
Registry last updated
Feb 6, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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