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

Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01170351

Enrollment

Registered

2010-07-27

Start date

2005-12-31

Completion date

2018-12-31

Last updated

2019-07-19

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

Conditions

Autoimmune Hepatitis

Keywords

autoimmune hepatitis, corticosteroids, cysclosporine-A, treatment, treatment-naive, induction of remossion, efficacy, tolerability

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.

Interventions

DRUGCyclosporine-A

Cyclosprorine-A will be administered to patients in group-B according to a set protocol and the patients will be followed at regular intervals with appropriate checking of clinical and para-clinical data.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

16 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

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

Countries

Iran

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026