A randomized, prospective, comparative study of the effectiveness of prophylactic entecavir treatment for HBV reactivation in past HBV infected patients with hematopoietic stem cell transplantatio
Not Applicable
- Conditions
- Diseases of the blood and blood-forming organs and certain disorders involving the immune mechanism
Recruitment & Eligibility
- Status
- ot yet recruiting
- 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
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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method comparison of HBV reactivation rate (HBsAg reverse seroconversion or detection of HBV DNA (=10 IU/mL))
- Secondary Outcome Measures
Name Time Method the rate of hepatitis due to HBV reactivation (Hepatitis: ALT levels more than twice of normal range);the rate of hepatic failure related to HBV reactivation;the rate of death due to hepatic failure related to HBV reactivation