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

Phase 3

Completed

• Conditions: Autoimmune Hepatitis
• Interventions: Drug: Cyclosporine-A

• Registration Number: NCT01170351
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-12
• Study First Submitted: 2010-07-24
• Study First Submitted QC: 2010-07-26
• Study First Posted: 2010-07-27
• Primary Completion: 2013-12
• Study Completion: 2018-12
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-17
• Last Update Posted: 2019-07-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 55

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group-A	Cyclosporine-A	Treatment-naive AIH patients consenting to participate
Group-B	Cyclosporine-A	Treatment-naive AIH patients consenting to participate. This group will receive Cyclosporine-A according to a set protocol.

Primary Outcome Measures

Name	Time	Method
Remission	12 months	AST/ALT less than 2x UNL No clinical symptom
Treatment failure	3 months	Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol

Secondary Outcome Measures

Name	Time	Method
Serious adverse event	12 months	Any adverse event requiring hospitalization or leading to disability or death
Frequency of adverse events	12 months	Any adverse event (related or unrelated to the study drug) occuring during the induction phase.

Trial Locations

Locations (1)

Digestive Disease Research Center, Shariati Hospital; 🇮🇷 Tehran, Iran, Islamic Republic of