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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005483

Enrollment

164

Registered

2020-10-15

Start date

2021-07-22

Completion date

Unknown

Last updated

2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Drug : The intervention group take entecavir 0.5mg everyday by oral administration for 3 years.

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
comparison of HBV reactivation rate (HBsAg reverse seroconversion or detection of HBV DNA (=10 IU/mL))	—

Secondary

Measure	Time frame
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	—

Countries

Korea, Republic of

Contacts

Public ContactSoon Kyu Lee

The Catholic University of Korea, Seoul St. Mary's Hospital

blackiqq@gmail.com+82-2-2258-2073

Outcome results