A pilot study of abatacept treatment for HBV fulminant hepatitis prevention.

Phase 1

• Conditions: Hepatitis B (acute infection, acute exacerbation, reactivation)

• Registration Number: JPRN-jRCTs061180029
• Lead Sponsor: Imamura Michio

Brief Summary

We conducted a pilot study for evaluating the efficacy and safety of abatacept, a cytotoxic T lymphocyte antigen-4 immunoglobulin (CTLA4), for acute hepatitis B. Five patients with severe acute hepatitis B (prothrombin activity < 60%) were treated for immunosuppression by abatacept. Five patients received abatacept concurrently with methylprednisolone, and another patient was treated with abatacept alone. Rapid decrease in serum alanine aminotransferase levels, increase in prothrombin activity and improveme

Detailed Description

Not available

Study Timeline

• Study Start: 2019-02-26
• Results First Posted: 2020-11-16
• Study Completion: 2022-04-25
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

Hospitalized patients who satisfied all of the following selection criteria for patients with hepatitis B (acute infection, acute exacerbation, reactivation), understand the purpose of this study, and consent by written document.

1) HBs antigen positive
2) ALT 100 IU / ml or more
3) Male and female with ages 18 to 85 at the time of acquiring consent

Exclusion Criteria

1) PT less than 10%
2) PT 61% or more, and either AST or ALT is on a downward trend
3) Hepatic encephalopathy 2 degrees or more (Table 2. Classification of coma of hepatic encephalopathy)
4) Patients with autoimmune hepatitis
5) Patients with a history of hypersensitivity to Orencia
6) Patients with severe infection
7) In addition, patients judged unsuitable for participation in this study by research doctor.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1) Ratio of patient with severe hepatitis improved one week after treatment (Ratio of patient that PT was restored than 70%)<br>2) Period of ALT being normalized <br>Safety (monitored clinical and laboratory evaluation)

Secondary Outcome Measures

Name	Time	Method
1) Administration status, dosing completion rate (percentage of cases that could be administered)<br>2) Measure T helper 1 / T helper 2 (T1 / T2)<br>Before administration, 30 minutes, Day1,2,3