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Completed

NCT Number: NCT02201940

Sofosbuvir/Velpatasvir Fixed Dose Combination for 12 Weeks in Adults With Chronic HCV Infection

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed dose combination (FDC) for 12 weeks in adults with chronic genotype 1, 2, 4, 5, or 6 hepatitis C virus (HCV) infection.

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Key information

Conditions

Hepatitis C Virus Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Fibrosis Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Antwerp, Belgium

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Willing and able to provide written informed consent
  • HCV RNA ≥ 10^4 IU/mL at screening
  • HCV genotype 1, 2, 4, 5, 6, or indeterminate assessed at screening by the central laboratory
  • Chronic HCV infection (≥ 6 months) documented by prior medical history or liver biopsy
  • Classification as treatment naive or treatment experienced
  • 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) or any other major medical disorder that may interfere with treatment, assessment, or compliance with the protocol; individuals currently under evaluation for a potentially clinically-significant illness (other than HCV) are also excluded.
  • Screening ECG with clinically significant abnormalities
  • Laboratory results outside of acceptable ranges at Screening
  • Prior exposure to SOF or other nucleotide analogue HCV NS5B inhibitor or any HCV NS5A inhibitor
  • Infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV)

Treatment and study plan

SOF/VEL

Drug

400/100 mg FDC tablet administered orally once daily

Other names: Epclusa®, GS-7977/GS-5816

Placebo

Drug

Tablet administered orally once daily

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response (SVR) 12 Weeks After Discontinuation of Therapy (SVR12)

    Time frame: Posttreatment Week 12

    SVR12 was defined as HCV RNA < the lower limit of quantitation (LLOQ; ie, 15 IU/mL) at 12 weeks after stopping study treatment.

  2. Percentage of Participants Who Permanently Discontinued Any Study Drug Due to an Adverse Event

    Time frame: Up to 12 weeks

Secondary outcomes

  1. Percentage of Participants With SVR at 4 and 24 Weeks After Discontinuation of Therapy (SVR4 and SVR24)

    Time frame: Posttreatment Weeks 4 and 24

    SVR4 and SVR 24 were defined as HCV RNA < LLOQ at 4 and 24 weeks after stopping study treatment, respectively.

  2. Percentage of Participants With HCV RNA < LLOQ at Weeks 1, 2, 4, 6, 8, 10, and 12

    Time frame: Weeks 1, 2, 4, 6, 8, 10, and 12

  3. Change From Baseline in HCV RNA at Weeks 1, 2, 4, 6, 8, 10, and 12

    Time frame: Baseline; Weeks 1, 2, 4, 6, 8, 10, and 12

  4. Percentage of Participants With Virologic Failure

    Time frame: Up to Posttreatment Week 24

    Virologic failure was defined as:

    • On-treatment virologic failure:
    • Breakthrough (confirmed HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ while on treatment), or
    • Rebound (confirmed > 1 log10 IU/mL increase in HCV RNA from nadir while on treatment), or
    • Non-response (HCV RNA persistently ≥ LLOQ through 8 weeks of treatment)
    • Virologic relapse:
    • Confirmed HCV RNA ≥ LLOQ during the posttreatment period having achieved HCV RNA < LLOQ at last on-treatment visit.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Sofosbuvir/GS-5816 Fixed Dose Combination for 12 Weeks in Subjects With Chronic HCV

Acronym: ASTRAL-1

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 28, 2014
Registry last updated
Nov 15, 2018

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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