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

July 17, 2019 updated by: Siavosh Nasseri-Moghadam, Tehran University of Medical Sciences

Comparing Efficacy and Tolerability of Cyclosporine-A vs. 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

55

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 63 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group-A
Treatment-naive AIH patients consenting to participate
Drug: Cyclosporine-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.
Experimental: Group-B
Treatment-naive AIH patients consenting to participate. This group will receive Cyclosporine-A according to a set protocol.
Drug: Cyclosporine-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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Remission
Time Frame: 12 months
AST/ALT less than 2x UNL No clinical symptom
12 months
Treatment failure
Time Frame: 3 months
Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol
3 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tehran University of Medical Sciences

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2005

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

December 1, 2018

Study Registration Dates

First Submitted

July 24, 2010

First Submitted That Met QC Criteria

July 26, 2010

First Posted (Estimate)

July 27, 2010

Study Record Updates

Last Update Posted (Actual)

July 19, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • DDRC-301174

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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