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Enrolling by Invitation

NCT Number: NCT04942886

Prophylactic Entecavir 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.

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Key information

Conditions

Hepatitis B Reactivation Antiviral Drug HBV Hematopoietic Stem Cell Transplantation

Age range

19 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Jeong Won Jang

Seoul, 06599, South Korea

About this study

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.
  • 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.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

  • 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
  • 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

Treatment and study plan

Baracle Tab.®

Drug

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

Other names: Prophylactic treatment group

Primary outcomes

  1. Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups.

    Time frame: The primary outcome is evaluated during 3 years after hematopoietic stem cell transplantation

    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

Secondary outcomes

  1. Comparison of the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups.

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

    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

  2. Comparison of the rate of hepatic failure related to HBV reactivation between the treatment and delayed treatment groups.

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

    Comparing the rate of hepatic failure between the treatment and delayed treatment groups.

  3. Comparison of the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.

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

    Comparing the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.

Sponsors and collaborators

Lead sponsor

Seoul St. Mary's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2028
Study completion
2028
First posted
Jun 29, 2021
Registry last updated
Jul 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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