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

Autoimmune Hepatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01170351
• Other study ID #: DDRC-301174
• Status: Completed
• Phase: Phase 3
• Start date: December 2005
• Est. completion date: December 2018

Study information

• Verified date: July 2019
• Source: Tehran University of Medical Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: December 2018
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Autoimmune Hepatitis
• Hepatitis
• Hepatitis A
• Hepatitis, Autoimmune

Intervention

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.

Locations

Country	Name	City	State
Iran, Islamic Republic of	Digestive Disease Research Center, Shariati Hospital	Tehran

Sponsors (1)

Lead Sponsor	Collaborator
Tehran University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Remission	AST/ALT less than 2x UNL No clinical symptom	12 months
Primary	Treatment failure	Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol	3 months
Secondary	Frequency of adverse events	Any adverse event (related or unrelated to the study drug) occuring during the induction phase.	12 months
Secondary	Serious adverse event	Any adverse event requiring hospitalization or leading to disability or death	12 months