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

NCT01170351 | Completed Phase 3

• 1 other identifier: DDRC-301174
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

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.

Conditions

Autoimmune Hepatitis

Keywords

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

Outcome Measures

Primary Outcomes (2)

• Remission

  AST/ALT less than 2x UNL No clinical symptom

  12 months

• Treatment failure

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

  3 months

Secondary Outcomes (2)

• Frequency of adverse events

  12 months

• Serious adverse event

  12 months

Study Arms (2)

Group-A

ACTIVE COMPARATOR

Treatment-naive AIH patients consenting to participate

Drug: Cyclosporine-A

Group-B

EXPERIMENTAL

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

Drug: Cyclosporine-A

Interventions

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.

Group-A; Group-B

Eligibility Criteria

• Age: 16 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Tehran University of Medical Sciences: lead

Study Sites (1)

Digestive Disease Research Center, Shariati Hospital

Tehran, 14117, Iran

Location

MeSH Terms

Conditions

Hepatitis, Autoimmune

Interventions

Cyclosporins

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, MPH, AGAF, Associate Professor of Medicine

Study Record Dates

• First Submitted: July 24, 2010
• First Posted: July 27, 2010
• Study Start: December 1, 2005
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2018
• Last Updated: July 19, 2019

Record last verified: 2019-07

Locations

IR (1)