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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified July 2010 by Tehran University of Medical Sciences.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01170351
First Posted: July 27, 2010
Last Update Posted: July 27, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Tehran University of Medical Sciences
July 24, 2010
July 27, 2010
July 27, 2010
December 2005
December 2013   (Final data collection date for primary outcome measure)
  • Remission [ Time Frame: 12 months ]
    AST/ALT less than 2x UNL No clinical symptom
  • Treatment failure [ Time Frame: 3 months ]
    Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol
Same as current
No Changes Posted
  • Frequency of adverse events [ Time Frame: 12 months ]
    Any adverse event (related or unrelated to the study drug) occuring during the induction phase.
  • Serious adverse event [ Time Frame: 12 months ]
    Any adverse event requiring hospitalization or leading to disability or death
Same as current
Not Provided
Not Provided
 
Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis
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.
Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Autoimmune Hepatitis
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.
  • Active Comparator: Group-A
    Treatment-naive AIH patients consenting to participate
    Intervention: Drug: Cyclosporine-A
  • Experimental: Group-B
    Treatment-naive AIH patients consenting to participate. This group will receive Cyclosporine-A according to a set protocol.
    Intervention: Drug: Cyclosporine-A
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
70
December 2014
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
16 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
 
NCT01170351
DDRC-301174
No
Not Provided
Not Provided
Siavosh Nasseri-Moghaddam MD, MPH, Associate Professor of Medicine, Digestive Disease Research Center, Tehran University of Medical Sciences
Tehran University of Medical Sciences
Not Provided
Not Provided
Tehran University of Medical Sciences
July 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP