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

• Status: Recruiting
• Trial end date: 2025-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Dong-Gun Lee
• Treatments: Entecavir

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:

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