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

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.
ClinicalTrials.gov Identifier: NCT01170351
Recruitment Status : Completed
First Posted : July 27, 2010
Last Update Posted : July 19, 2019
Sponsor:
Information provided by (Responsible Party):
Siavosh Nasseri-Moghadam, Tehran University of Medical Sciences

Tracking Information
First Submitted Date  ICMJE July 24, 2010
First Posted Date  ICMJE July 27, 2010
Last Update Posted Date July 19, 2019
Study Start Date  ICMJE December 2005
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01170351 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 26, 2010)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis
Official Title  ICMJE Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autoimmune Hepatitis
Intervention  ICMJE 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.
Study Arms  ICMJE
  • 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
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 17, 2019)
55
Original Estimated Enrollment  ICMJE
 (submitted: July 26, 2010)
70
Actual Study Completion Date  ICMJE December 2018
Actual Primary Completion Date December 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Iran, Islamic Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01170351
Other Study ID Numbers  ICMJE DDRC-301174
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Siavosh Nasseri-Moghadam, Tehran University of Medical Sciences
Study Sponsor  ICMJE Tehran University of Medical Sciences
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tehran University of Medical Sciences
Verification Date July 2019

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