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

JRCT ID: jRCTs061180029

Registered date:26/02/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hepatitis B (acute infection, acute exacerbation, reactivation)
• Date of first enrollment: 01/08/2018
• Target sample size: 10
• Countries of recruitment: Japan only,Japan
• Study type: Interventional
• Intervention(s): Intervention by medication administration

Outcome(s)

Primary Outcome

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

Secondary Outcome

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

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 85age old
• Gender: Both

Include 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

Exclude 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.

Related Information

• Primary Sponsor: Imamura Michio
• Secondary ID(s): UMIN000025725