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 25, 2025
Enrolling by invitation
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Seoul, 동작구, Korea, Republic Of
Seoul, , Korea, Republic Of
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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