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

A Randomized, Prospective, Comparative Study of the Effectiveness of Prophylactic Entecavir Treatment for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: HBV; Hematopoietic Stem Cell Transplantation; Hepatitis B Reactivation; Antiviral Drug
• Intervention / Treatment: Drug: Baracle Tab.®

Detailed Description

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 after allogeneic hematopoietic stem cell transplantation. The intervention group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months.

   * oral administration of entecavir is planned to start within 7 days after hematopoietic stem cell transplantation.

2. No Intervention: delayed treatment group (n=113) The delayed treatment group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months. If the patient in the delayed treatment group shows HBV reactivation (positive HBsAg or HBV DNA ≥10 IU/mL), entecavir treatment is started.

• Study Type: Interventional
• Enrollment (Estimated): 226
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 06599
    • Jeong Won Jang

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment group; The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after allogeneic hematopoietic stem cell transplantation. The intervention group visit clinic every month and examined liver function test, HBsAg/Ab. HBV DNA level is examined at every 3 months.	Drug: Baracle Tab.®; The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.; Other Names: Prophylactic treatment group
No Intervention: delayed treatment group; The delayed treatment group (control group) visit clinic every month and examined liver function test, HBsAg/Ab for 3 years after allogeneic hematopoietic stem cell transplantation. HBV DNA level is examined at every 3 months for 3 years after allogenic hematopoietic stem cell transplantation. If the patient in the delayed treatment group shows HBV reactivation (positive HBsAg or HBV DNA ≥10 IU/mL), entecavir treatment is started.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups.	Comparing the rate of HBV reactivation between the treatment and delayed treatment groups during 3 years after hematopoietic stem cell transplantation * Definition of HBV reactivation: HBsAg ≥ 1.0 S/CO or HBV DNA ≥ 10 IU/mL	The primary outcome is evaluated during 3 years after hematopoietic stem cell transplantation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Comparison of the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups.	Comparing the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups. * Definition of active hepatitis: ALT >= 2 times of upper normal limit	The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.
Comparison of the rate of hepatic failure related to HBV reactivation between the treatment and delayed treatment groups.	Comparing the rate of hepatic failure between the treatment and delayed treatment groups.	The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.
Comparison of the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.	Comparing the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.	The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.

Collaborators and Investigators

• Sponsor: Seoul St. Mary's Hospital
• Investigators: Study Chair: Jeong Won Jang, Professor, Seoul St. Mary's Hospital, The Catholic University of Korea

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: June 15, 2021
• First Submitted That Met QC Criteria: June 20, 2021
• First Posted (Actual): June 29, 2021

Study Record Updates

• Last Update Posted (Actual): July 18, 2025
• Last Update Submitted That Met QC Criteria: July 15, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Keywords: hematopoietic stem cell transplantation; Hepatitis B Reactivation; Prophylatic antiviral agents; Past HBV infection
• Additional Relevant MeSH Terms: Blood-Borne Infections; Infections; Virus Diseases; Digestive System Diseases; Liver Diseases; Hepatitis, Viral, Human; Communicable Diseases; DNA Virus Infections; Hepadnaviridae Infections; Hepatitis; Hepatitis B; Anti-Infective Agents; Antiviral Agents; Entecavir
• Other Study ID Numbers: KC20MISI0622

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: According to the guideline of our institutional review board, the patient data could not be opened to other researchers.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No