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Comparison of Two Medications (Azathioprine or Mycophenolate mofetil)for Treating Autoimmune Hepatitis; AMA trial.

Induction of Remission in Autoimmune Hepatitis with Azathioprine vs. MMF- IMPAIR trial - IMPAIR trial

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2024/11/076428
Enrollment
108
Registered
2024-11-08
Start date
Unknown
Completion date
Unknown
Last updated
2026-04-27

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

Conditions

Health Condition 1: K754- Autoimmune hepatitis

Interventions

Intervention1: Comparision of Mycophenolate mofetil and azathioprine in autoimmune hepatitis.: Mycophenolate mofetil and azathioprine will be compared in treatment naive autoimmune hepatitis. MMF will

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Autoimmune hepatitis. Treatment naive. Subject who gives the consent to participate in the study.

Exclusion criteria

Exclusion criteria: Acute liver failure Platelets count less than 50000 TLC counts less than 3000 Existing liver disease, e.g. hepatitis B, C, PBC, PSC, alcohol intake, obesity Previous treatment exposure Lactating women and pregnancy HCC or other malignancy Allergic to specific medications A patient who is not willing to participate in the study or failed to provide the consent

Design outcomes

Primary

MeasureTime frame
The primary outcome measure is reversing biochemical activity over a 24-week.Timepoint: Initially at two weeks, then at one-month intervals.

Secondary

MeasureTime frame
1. Study the adverse effects safety of MMF 2. Improvement in the quality of life index 3. Reversal of stage of fibrosis 4. No progression of fibrosis(by fibroscan)Timepoint: Initially, it was 2 weeks, then at a one-month interval.

Countries

India

Contacts

Public ContactDr Babu Lal Meena

ILBS Delhi

drbabupgi@gmail.com9781100898

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: May 1, 2026