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

NCT04942886 | Enrolling By Invitation

• 1 other identifier: KC20MISI0622
• Study Type: interventional
• Target: 226
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatitis B Reactivation; Hematopoietic Stem Cell Transplantation; Antiviral Drug; HBV

Keywords

Hepatitis B Reactivation; hematopoietic stem cell transplantation; Prophylatic antiviral agents; Past HBV infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Comparison of the rate of active hepatitis with HBV reactivation 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 hepatic failure related to HBV reactivation 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.

  The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.

Study Arms (2)

Treatment group

EXPERIMENTAL

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.®

delayed treatment group

NO INTERVENTION

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.

Interventions

Baracle Tab.® DRUG

The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.

Also known as: Prophylactic treatment group

Treatment group

Eligibility Criteria

• Age: 19 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul St. Mary's Hospital: lead

Study Sites (1)

Jeong Won Jang

Seoul, 06599, South Korea

Location

Study Officials

• Jeong Won Jang, Professor

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

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: June 15, 2021
• First Posted: June 29, 2021
• Study Start: August 21, 2021
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: July 18, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)