Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
N/A |
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.
- 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.
- 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 Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Treatment group 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. |
Drug: Entecavir
The intervention group take entecavir 0.5mg everyday by oral administration for 3 years after hematopoietic stem cell transplantation.
Other Names:
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No Intervention: delayed treatment group 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. |
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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 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.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age: 19 - 70
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patients receiving hematopoietic stem cell transplantation
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HBV serologic test: HBsAg (-), anti-HBc IgG (+)
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ECOG performence: 0-2
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patients with informed consent
Exclusion Criteria:
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HBV DNA (+, ≥10 IU/mL) at the time of screening
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Receiving hematopoietic stem cell transplantation from donor with HBsAg+
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Combined other chronic liver disease (severe alcoholics, autoimmune hepatitis, chronic hepatitis C etc.)
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HIV (+)
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Previous antiviral therapy history for chronic hepatitis B
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Other concomitant malignancy
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combined autoimmune disease (rheumatic arthritis, SLE etc)
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CTP class B, C
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Decompensated complications (ascites, hepatic encephalopathy etc.)
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active tuberculosis
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Jeong Won Jang | Seoul | 동작구 | Korea, Republic of | 06599 |
Sponsors and Collaborators
- Dong-Gun Lee
Investigators
- Study Chair: Jeong Won Jang, Professor, Seoul St. Mary's Hospital, the catholic university of Korea
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KC20MISI0622