Tacrolimus as Second-line Therapy
Phase 2
- Conditions
- Autoimmune Hepatitis
- Registration Number
- JPRN-jRCTs061180063
- Lead Sponsor
- Chayama Kazuaki
- Brief Summary
Patients scheduled to be registered have improved. There were no other eligible cases.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 0
Inclusion 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
Exclusion 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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The rate of patients who had normal ALT at 2 weeks from initial tacrolimus treatment<br>The duration which had normal ALT at 2 weeks from initial tacrolimus treatment <br>The rate of patients who had normal IgG at 2 weeks from initial tacrolimus treatment<br>The duration which had normal IgG at 2 weeks from initial tacrolimus treatment<br>The rate of patients who had normal ALT at 2 years from initial tacrolimus treatment<br>The rate of patients who had normal IgG at 2 years from initial tacrolimus treatment
- Secondary Outcome Measures
Name Time Method safety