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

Seoul St. Mary's Hospital

Status: Invitation-only

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

Treatments: Drug: Baracle Tab.®

Study type: Interventional

Funder types: Other

Identifiers

NCT04942886

KC20MISI0622

Details and patient eligibility

About

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.

Full 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.

Enrollment: 226 estimated patients

Sex: All

Ages: 19 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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226 participants in 2 patient groups

Treatment group

Experimental group

Description:

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.

Treatment:

Drug: Baracle Tab.®

delayed treatment group

No Intervention group

Description:

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.