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Completed

NCT Number: NCT01170351

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

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.

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Key information

Conditions

Autoimmune Hepatitis Autoimmune Diseases Digestive System Diseases Hepatitis Hepatitis, Autoimmune Hepatitis, Chronic Immune System Diseases Liver Diseases

Age range

16 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Digestive Disease Research Center, Shariati Hospital

Tehran, 14117, Iran

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cyclosporine-A

Drug

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.

Primary outcomes

  1. Remission

    Time frame: 12 months

    AST/ALT less than 2x UNL No clinical symptom

  2. Treatment failure

    Time frame: 3 months

    Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol

Secondary outcomes

  1. Frequency of adverse events

    Time frame: 12 months

    Any adverse event (related or unrelated to the study drug) occuring during the induction phase.

  2. Serious adverse event

    Time frame: 12 months

    Any adverse event requiring hospitalization or leading to disability or death

Sponsors and collaborators

Lead sponsor

Tehran University of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2013
Study completion
2018
First posted
Jul 27, 2010
Registry last updated
Jul 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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