Tacrolimus as Second-line Therapy

JRCT ID: jRCTs061180063

Registered date:18/03/2019

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Autoimmune Hepatitis
• Date of first enrollment: 01/10/2018
• Target sample size: 5
• Study type: Interventional
• Intervention(s): Intervention by medication administration

Outcome(s)

Primary Outcome

The rate of patients who had normal ALT at 2 weeks from initial tacrolimus treatment
The duration which had normal ALT at 2 weeks from initial tacrolimus treatment
The rate of patients who had normal IgG at 2 weeks from initial tacrolimus treatment
The duration which had normal IgG at 2 weeks from initial tacrolimus treatment
The rate of patients who had normal ALT at 2 years from initial tacrolimus treatment
The rate of patients who had normal IgG at 2 years from initial tacrolimus treatment

• Secondary Outcome: safety

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: <= 80age old
• Gender: Both

Include criteria

1)Patients who had diagnosis of Autoimmune Hepatitis by guideline of 2013
2)Patients is poorly tolerated by Predniso(lo)ne, alone or in combination with azathioprine
3)Patients who can not treated with azathioprine due to adverse event

Exclude criteria

1.Liver cirrhosis
2.HBV , HCV, PBC, NASH
3.Arrergy of Tacrolimus
4.Arrergy of ciclosporin
5.Patents who treated with potassium-conserving diuretic
6.Pregnancy
7.Patients who hope of pregnancy
8.Severe infection
9.Patients who judge exclusion criteria by doctor

Related Information

• Primary Sponsor: Chayama Kazuaki
• Secondary ID(s): UMIN000030743