Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis

Tehran University of Medical Sciences

Status and phase

Completed

Phase 3

Conditions

Autoimmune Hepatitis

Treatments

Drug: Cyclosporine-A

Study type

Interventional

Funder types

Other

Identifiers

NCT01170351

DDRC-301174

Details and patient eligibility

About

Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are corticosteroids (CS). In addition to being ineffective a substantial minority of cases, corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options for induction of remission are limited. There are reports of successful salvage therapy with Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled studies have shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no studies comparing CsA and CS in a head to head trial. The investigators aim to assess the efficacy and tolerability of CsA directly to the CS for induction of remission in treatment-naive AIH patients.

Enrollment

55 patients

Sex

All

Ages

16 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

16-65 years old individuals with probable of definite AIH according to the revised AIH criteria.
Willing and able to participate in the study

Exclusion criteria

Non-consenting patients
decompensated cirrhosis, i.e. clinical ascites, hepatic encephalopathy, history of variceal bleeding
Presence of serious concomitant cardiovascular, pulmonary or renal condition
Presence of active malignant disorder