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Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation

StatusEnrolling by Invitation
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

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  1. Minor Eligibility criteria shortened, about 14 wordsv5
  2. Notable Lead sponsor: Dong-Gun Lee to Seoul St. Mary's Hospitalv4 Show 5 more changesShow less
    • Primary and study completion dates: Dec 31, 2025 to Dec 31, 2028
    • Enrollment target: 164 to 226
    • Interventions: Entecavir (Drug) to Baracle Tab.® (Drug)
    • Eligibility criteria expanded, about 32 words
    • Study description expanded, about 2 words
  3. Minor Trial status: Recruiting to Enrolling by Invitation
    • Start date changed from estimate of Jul 25, 2021 to Aug 21, 2021
    • Site details revised
    v3
  4. Minor Start date: Jul 1, 2021 to Jul 25, 2021
    • Study description expanded, about 37 words
    v2
  5. Minor 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 study is a randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients (HBsAg-, HBcIgG+) with allogeneic hematopoietic stem cell transplantation.
Trial Details
NCT Number NCT04942886
Lead Sponsor Seoul St. Mary's Hospital
Conditions
(from sponsor)
Hepatitis B Reactivation, Hematopoietic Stem Cell Transplantation, Antiviral Drug, HBV
Enrollment 226 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov