Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Baracle Tab.®.
- Who it may be relevant to
- Registry conditions: Hepatitis B Reactivation, Hematopoietic Stem Cell Transplantation, Antiviral Drug, HBV. Basic parameters: 19 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
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 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.
Interventions
- Drug Baracle Tab.®
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.
Primary outcome measures
- 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]
Secondary outcome measures (3)
- 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.]
- 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.]
- 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.]
Eligibility criteria
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Jeong Won Jang — Seoul
Identifiers
NCT: NCT04942886 · KC20MISI0622