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

Hematopoietic Stem Cell Transplantation Clinical Trial

Official 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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04942886
• Other study ID #: KC20MISI0622
• Status: Enrolling by invitation
• Phase: N/A
• Start date: August 21, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: December 2022
• Source: Seoul St. Mary's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 164
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 70 Years

Eligibility

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

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

Related Conditions & MeSH terms

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

Intervention

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

Locations

Country	Name	City	State
Korea, Republic of	Jeong Won Jang	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong-Gun Lee

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.