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

Not Applicable

• Conditions: Hematopoietic Stem Cell Transplantation; Hepatitis B Reactivation; Antiviral Drug; HBV
• Interventions: Drug: Entecavir

• Registration Number: NCT04942886
• Lead Sponsor: Dong-Gun Lee

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 hematopoietic stem cell transplantation.

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 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=82) The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after 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=82) 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 Timeline

• Study First Submitted: 2021-06-15
• Study First Submitted QC: 2021-06-20
• Study First Posted: 2021-06-29
• Study Start: 2021-08-21
• Status Verified: 2022-12
• Last Update Submitted: 2022-12-16
• Last Update Posted: 2022-12-19
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 164

Inclusion Criteria

1. Age: 19 - 70
2. patients receiving hematopoietic stem cell transplantation
3. HBV serologic test: HBsAg (-), anti-HBc IgG (+)
4. ECOG performence: 0-2
5. patients with informed consent

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Exclusion Criteria

1. HBV DNA (+, ≥10 IU/mL) at the time of screening
2. Receiving hematopoietic stem cell transplantation from donor with HBsAg+
3. Combined other chronic liver disease (severe alcoholics, autoimmune hepatitis, chronic hepatitis C etc.)
4. HIV (+)
5. Previous antiviral therapy history for chronic hepatitis B
6. Other concomitant malignancy
7. combined autoimmune disease (rheumatic arthritis, SLE etc)
8. CTP class B, C
9. Decompensated complications (ascites, hepatic encephalopathy etc.)
10. active tuberculosis

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment group	Entecavir	The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after 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.

Primary Outcome Measures

Name	Time	Method
Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups.	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 Outcome Measures

Name	Time	Method
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.	Comparing the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.
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.	Comparing the rate of hepatic failure between the treatment and delayed treatment groups.
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.	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

Trial Locations

Locations (1)

Jeong Won Jang; 🇰🇷 Seoul, Korea, Republic of