Clinical trial NCT04942886: Prophylactic Entecavir for HBV Reactivation in Past HBV Infected Patients With Hematopoietic Stem Cell Transplantation
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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Hepatitis B Reactivation
Hematopoietic Stem Cell Transplantation
Antiviral Drug
HBV
Keywords: Hepatitis B Reactivation
hematopoietic stem cell transplantation
Prophylatic antiviral agents
Past HBV infection
Lead sponsor: Seoul St. Mary's Hospital
Sponsor class: OTHER
First posted: 2021-06-29
Enrollment: 164
Sex: ALL
Minimum age (years): 19
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

1. 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.
2. 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.

Eligibility 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

Primary outcomes:
measure: Comparison of the rate of HBV reactivation between the treatment and delayed treatment groups.
timeFrame: The primary outcome is evaluated during 3 years after hematopoietic stem cell transplantation
Secondary outcomes:
measure: Comparison of the rate of active hepatitis with HBV reactivation between the treatment and delayed treatment groups.
timeFrame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.
measure: Comparison of the rate of hepatic failure related to HBV reactivation between the treatment and delayed treatment groups.
timeFrame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.
measure: Comparison of the rate of survival related to HBV reactivation between the treatment and delayed treatment groups.
timeFrame: The secondary outcomes are evaluated during 3 years after hematopoietic stem cell transplantation.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Jeong Won Jang
Study officials:
affiliation: Seoul St. Mary's Hospital, the catholic university of Korea
name: Jeong Won Jang, Professor
role: STUDY_CHAIR
References: