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Sofosbuvir/Velpatasvir Treatment of Chronic Hepatitis C During Pregnancy

Study acronym: STORC
StatusActive, Not Recruiting
PhasePhase 4
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 15, 2026 (before its estimated August 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Trial status changed: Recruiting → Active, Not Recruiting
    • Primary completion pushed from Apr 2026 to Aug 2026
    • Study completion pushed from Jun 2026 to Jun 2027
    • Site details revised at 9 of 9 sites
    v11
  2. Study sites: 8 to 9
    • Primary completion date: Dec 2025 to Apr 2026
    v10
  3. Primary completion date: Jun 2025 to Dec 2025
    • Study completion date: Dec 2025 to Jun 2026
    v9
  4. Study sites: 7 to 8
    • Primary completion date: Dec 2024 to Jun 2025
    v8
  5. Primary completion date: Apr 2024 to Dec 2024
    • Study sites: 5 to 7
    • Study completion date: Apr 2025 to Dec 2025
    v7
Show 5 earlier versionsHide 5 earlier versions
  1. Study sites: 4 to 5v6
  2. Study sites: 5 to 4v5
  3. Lead sponsor: Catherine Chappell to Catherine Anne Chappell
    • Study sites: 1 to 5
    v4
  4. Trial status: Not Yet Recruiting to Recruitingv3 Show 4 more changesShow less
    • Primary completion date: Apr 1, 2024 to Apr 2024
    • Study completion date: Apr 1, 2025 to Apr 2025
    • Start date changed from estimate of Apr 1, 2022 to Apr 4, 2022
    • Site details revised
  5. Start date: Feb 1, 2022 to Apr 1, 2022
    • Primary completion date: Mar 1, 2024 to Apr 1, 2024
    • Study completion date: Dec 31, 2024 to Apr 1, 2025
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
This is a multicenter, single arm study of Sofosbuvir/Velpatasvir (SOF/VEL) for treatment of chronic hepatitis C infection during pregnancy. Treatment will be initiated during the second or third trimester in approximately 100 pregnant people. Maternal participants will take one SOF/VEL tablet once daily for 12 weeks (84 days) and followed until 12 weeks after treatment completion (postpartum). Infants will be followed from birth until one year of age. The primary objectives are to evaluate the sustained virologic response 12 weeks after completion of SOF/VEL treatment (SVR12) in participants treated during pregnancy and to evaluate impact of antenatal treatment with SOF/VEL on the gestational age at delivery.
Trial Details
NCT Number NCT05140941
Lead Sponsor Catherine Anne Chappell
Collaborators: Gilead Sciences
Conditions
(from sponsor)		 Hepatitis C, Chronic, Pregnancy; Infection
Related terms Hepatitis C, Chronic, Pregnancy Complications, Infectious
Enrollment 100 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov