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Completed

NCT Number: NCT04211909

Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC for 12 Weeks in Adults With Chronic Hepatitis C Virus (HCV) Infection

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of therapy with Sofosbuvir/Velpatasvir (SOF/VEL) Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir/Voxilaprevir (SOF/VEL/VOX ) FDC in participants with chronic HCV infection.

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Key information

Conditions

Hepatitis C Virus Infection Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis C Hepatitis, Viral, Human Infections Liver Diseases RNA Virus Infections Virus Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Seoul National University Bundang Hospital, Seongnam-si, Gyeonggi-D, South Korea

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • Chronic HCV infected males and non-pregnant/non-lactating females
  • Treatment-naive or treatment-experienced individuals
  • Non-cirrhosis or compensated cirrhosis at screening

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Treatment and study plan

SOF/VEL

Drug

400/100 mg FDC tablet orally once daily.

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

SOF/VEL/VOX

Drug

400/100/100 mg FDC tablet orally once daily.

Other names: Vosevi ®, GS-7977/GS-5816/GS-9857

Primary outcomes

  1. Percentage of Participants With Sustained Virologic Response (SVR) < Lower Limit of Quantification (LLOQ) 12 Weeks After Discontinuation of Study Treatment

    Time frame: Posttreatment Week 12

    SVR12 was defined as HCV RNA < LLOQ (i.e., 15 IU/mL) at 12 weeks after stopping study treatment.

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

    Time frame: First dose date up to 12 weeks plus 30 days

Secondary outcomes

  1. Percentage of Participants With SVR < LLOQ 4 Weeks After Discontinuation of Study Treatment

    Time frame: Posttreatment Week 4

    SVR4 was defined as HCV RNA < LLOQ (i.e.15 IU/mL) 4 weeks after stopping study treatment.

  2. Percentage of Participants With Virologic Failure

    Time frame: Baseline up to Posttreatment Week 12

    Virologic failure was defined as:

    On-treatment virologic failure:

    • Breakthrough (HCV RNA ≥ LLOQ after having previously had HCV RNA < LLOQ, while on treatment, confirmed with 2 consecutive values), 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

  3. Percentage of Participants With HCV RNA < LLOQ on Treatment

    Time frame: Week 2, Week 4, Week 8, Week 12

    LLOQ was 15 IU/mL.

  4. Change From Baseline in HCV RNA

    Time frame: Baseline, Week 2, Week 4, Week 8, Week 12

  5. Number of Participants With Alanine Aminotransferase (ALT) Normalization

    Time frame: Baseline, Week 2, Week 4, Week 8, Week 12

    Number of participants with ALT normalization, defined as ALT > upper limit of normal (ULN) (ULN = 43 U/L) at baseline and ALT ≤ ULN, at each visit was presented.

Sponsors and collaborators

Lead sponsor

Gilead Sciences

Industry

Registry information

Official study title

A Phase 3b Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination and Sofosbuvir/Velpatasvir/Voxilaprevir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic HCV Infection

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 26, 2019
Registry last updated
Oct 27, 2021

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

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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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