Evaluation of safety and protective efficacy of fulminant hepatitis to abatacept treatment of patients with HBV-related severe hepatitis.-Pilot Study-

Evaluation of safety and protective efficacy of fulminant hepatitis to abatacept treatment of patients with HBV-related severe hepatitis.-Pilot Study- - A pilot study of abatacept treatment for HBV fulminant hepatitis prevention.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000025725

Enrollment

Registered

2017-02-01

Start date

2017-02-01

Completion date

Unknown

Last updated

2026-06-29

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

Conditions

HBV-related acute severe hepatitis

Interventions

To evaluate safety and efficacy to abatacept treatment of patients with predicted HBV-related fulminant hepatitis.

Eligibility

Sex/Gender

All

Inclusion criteria

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 antig en positive 2) ALT 100 IU / ml or more 3) Male and female with ag es 18 to 85 at the time of acquiring consent

Exclusion criteria

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 deg rees or more 4) Patients with autoimmune hepatitis 5) Patients with a history of hypersensitivity to orencia 6) Patients with severe infection 7) In addition, patients judg ed unsuitable for participation in this study by research doctor.

Design outcomes

Primary

Measure	Time frame
Ratio of patient with severe hepatitis improved one week after treatment (Ratio of patient that PT was restored than 70%)	—

Secondary

Measure	Time frame
Period of ALT being normalized Safety (moniterd clinical and laboratory evaluation)	—

Countries

Japan

Contacts

Public ContactTakashi Nakahara

graduate school of biomedical science, Hiroshima university. Department and medicine and molecular science

nakahara@hiroshima-u.ac.jp082-257-5190

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026