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Search / Trial NCT04942886

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

Launched by SEOUL ST. MARY'S HOSPITAL · Jun 20, 2021

Trial Information

Current as of July 23, 2025

Enrolling by invitation

Keywords

Hepatitis B Reactivation Hematopoietic Stem Cell Transplantation Prophylatic Antiviral Agents Past Hbv Infection

ClinConnect Summary

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.

In this study, patients are randomized into treatment group or delayed treatment group.

\* Stratified randomization (Block randomization within strata) according to the presence of HBsAb at baseline was used in this study.

1. Experimental: Treatment group (n=113) The intervention group take entecavir 0.5mg everyday by oral administration for 3 years ...

Gender

ALL

Eligibility criteria

  • 1. Inclusion Criteria:
  • Age: 19 - 70
  • Patients receiving allogeneic hematopoietic stem cell transplantation
  • HBV serologic test: HBsAg (-), anti-HBc IgG (+) before receiving allogeneic hematopoietic stem cell transplantation
  • ECOG performence: 0-2
  • patients with informed consent
  • 2. Exclusion Criteria:
  • HBV DNA (+, ≥10 IU/mL) at the time of screening
  • Receiving hematopoietic stem cell transplantation from donor with HBsAg+
  • Combined other chronic liver disease (severe alcoholics, autoimmune hepatitis, chronic hepatitis C etc.)
  • HIV (+)
  • Previous antiviral therapy history for chronic hepatitis B
  • Other concomitant malignancy
  • Combined autoimmune disease (rheumatic arthritis, SLE etc)
  • CTP class B, C
  • Decompensated complications (ascites, hepatic encephalopathy etc.)
  • Active tuberculosis
  • Patients with lymphoma
  • Patients receiving autologous hematopoietic stem cell transplantation

About Seoul St. Mary's Hospital

Seoul St. Mary's Hospital, a leading healthcare institution in South Korea, is dedicated to advancing medical research and improving patient outcomes through innovative clinical trials. Affiliated with the Catholic University of Korea, the hospital combines state-of-the-art facilities with a commitment to high-quality patient care and ethical research practices. With a multidisciplinary team of experienced researchers and clinicians, Seoul St. Mary's Hospital actively participates in a wide range of clinical studies, focusing on diverse therapeutic areas to contribute valuable insights to the global medical community.

Locations

Seoul, 동작구, Korea, Republic Of

Seoul, , Korea, Republic Of

Patients applied

0 patients applied

Trial Officials

Jeong Won Jang, Professor

Study Chair

Seoul St. Mary's Hospital, the catholic university of Korea

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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