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

This study is currently recruiting participants.
Verified July 2010 by Tehran University of Medical Sciences
Sponsor:
Information provided by:
Tehran University of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01170351
First received: July 24, 2010
Last updated: July 26, 2010
Last verified: July 2010
History of Changes
  Purpose

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.


Condition Intervention Phase
Autoimmune Hepatitis
 Drug: Cyclosporine-A
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Tehran University of Medical Sciences:

Primary Outcome Measures:
  • Remission [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    AST/ALT less than 2x UNL No clinical symptom

  • Treatment failure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol


Secondary Outcome Measures:
  • Frequency of adverse events [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    Any adverse event (related or unrelated to the study drug) occuring during the induction phase.

  • Serious adverse event [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Any adverse event requiring hospitalization or leading to disability or death


Estimated Enrollment: 70
Study Start Date: December 2005
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   16 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01170351

Contacts
Contact: Siavosh Nasseri-Moghaddam, MD, MPH +98-21-88052286 sianasseri@yahoo.com
Contact: Reza Malekzadeh, MD +98-2188012992 rmalekzadeh2@gmail.com

Locations
Iran, Islamic Republic of
Digestive Disease Research Center, Shariati Hospital Recruiting
Tehran, Iran, Islamic Republic of, 14117
Contact: Reza Malekzadeh, MD     +98-21-88012992        
Principal Investigator: Siavosh Nasseri-Moghaddam, MD, MPH            
Sponsors and Collaborators
Tehran University of Medical Sciences
  More Information

No publications provided

Responsible Party: Siavosh Nasseri-Moghaddam MD, MPH, Associate Professor of Medicine, Digestive Disease Research Center, Tehran University of Medical Sciences
ClinicalTrials.gov Identifier: NCT01170351     History of Changes
Other Study ID Numbers: DDRC-301174
Study First Received: July 24, 2010
Last Updated: July 26, 2010
Health Authority: Iran: Ministry of Health

Keywords provided by Tehran University of Medical Sciences:
autoimmune hepatitis
corticosteroids
cysclosporine-A
treatment
 treatment-naive
induction of remossion
efficacy
tolerability

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Autoimmune
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepatitis, Chronic
Autoimmune Diseases
Immune System Diseases
Cyclosporins
Cyclosporine
 Methylprednisolone acetate
Prednisolone acetate
Prednisolone
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antifungal Agents
Anti-Infective Agents

ClinicalTrials.gov processed this record on May 21, 2013