Comparison of Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Adults With Chronic Genotype 3 HCV Infection (ASTRAL-3)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT02201953
First received: July 24, 2014
Last updated: December 8, 2015
Last verified: December 2015
  Purpose
This study will evaluate the safety, tolerability, and efficacy of treatment with sofosbuvir (SOF)/velpatasvir (VEL; GS-5816) fixed dose combination (FDC) for 12 weeks compared to treatment with SOF plus ribavirin (RBV) for 24 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection.

Condition Intervention Phase
Hepatitis C Virus Infection
Drug: SOF/VEL
Drug: SOF
Drug: RBV
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 3, Multicenter, Randomized, Open-Label Study to Compare the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks With Sofosbuvir and Ribavirin for 24 Weeks in Subjects With Chronic Genotype 3 HCV Infection

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Proportion of participants with sustained virologic response 12 weeks after discontinuation of therapy (SVR12) [ Time Frame: Posttreatment Week 12 ] [ Designated as safety issue: No ]
    SVR12 is defined as HCV RNA < the lower limit of quantitation (LLOQ) 12 weeks following the last dose of study drug.

  • Incidence of adverse events leading to permanent discontinuation of study drug(s) [ Time Frame: Up to 24 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants with sustained virologic response 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) [ Time Frame: Posttreatment Weeks 4 and 24 ] [ Designated as safety issue: No ]
    SVR4 and SVR24 are defined as HCV RNA < LLOQ at 4 and 24 weeks following the last dose of study drug.

  • Proportion of participants with HCV RNA < LLOQ on treatment [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • HCV RNA change from baseline [ Time Frame: Up to 8 weeks ] [ Designated as safety issue: No ]
  • Proportion of participants with virologic failure [ Time Frame: Up to Posttreatment Week 24 ] [ Designated as safety issue: No ]

    Virologic failure is defined as

    • On-treatment virologic failure

      • HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment,
      • > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment,
      • HCV RNA persistently ≥ LLOQ through 8 weeks of treatment (ie nonresponse)
    • Relapse

      • HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at end of treatment, confirmed with 2 consecutive values or last available posttreatment measurement


Enrollment: 558
Study Start Date: July 2014
Study Completion Date: December 2015
Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SOF/VEL 12 Weeks
Participants will receive SOF/VEL FDC for 12 weeks.
Drug: SOF/VEL
SOF/VEL (400/100 mg) FDC tablet administered orally once daily
Other Name: GS-7977/GS-5816
Experimental: SOF+RBV 24 Weeks
Participants will receive SOF plus RBV for 24 weeks.
Drug: SOF
SOF 400 mg tablet administered orally once daily
Other Names:
  • Sovaldi®
  • GS-7977
  • PSI-7977
Drug: RBV
RBV tablets administered orally in a divided daily dose according to package insert weight-based dosing recommendations (< 75 kg = 1000 mg and ≥ 75 kg = 1200 mg)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Willing and able to provide written informed consent
  • HCV RNA ≥ 10^4 IU/mL
  • HCV genotype 3
  • Chronic HCV infection (≥ 6 months)
  • Females of childbearing potential must have a negative serum pregnancy test
  • Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception

Exclusion Criteria:

  • Current or prior history of clinically-significant illness (other than HCV) that may interfere with subject treatment, assessment or compliance with the protocol
  • Screening ECG with clinically significant abnormalities
  • Laboratory results outside of acceptable ranges at Screening
  • Pregnant or nursing female or male with pregnant female partner
  • Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)
  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: NCT02201953

  Show 76 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: John McNally, PhD Gilead Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02201953     History of Changes
Other Study ID Numbers: GS-US-342-1140  2014-001682-27 
Study First Received: July 24, 2014
Last Updated: December 8, 2015
Health Authority: United States: Food and Drug Administration
Canada: Health Canada
Australia: Department of Health and Ageing Therapeutic Goods Administration
New Zealand: Medsafe
Germany: Federal Institute for Drugs and Medical Devices
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Italy: The Italian Medicines Agency
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Gilead Sciences:
Sofosbuvir
SOF/VEL
GS-5816
Hepatitis C
HCV
cirrhosis

Additional relevant MeSH terms:
Hepatitis C
Hepatitis
Infection
Communicable Diseases
Virus Diseases
Hepatitis, Viral, Human
Flaviviridae Infections
RNA Virus Infections
Liver Diseases
Digestive System Diseases
Ribavirin
Sofosbuvir
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antiviral Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on August 28, 2016