Back to resultsCyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis
Primary Purpose
Autoimmune Hepatitis
Status
Completed
Phase
Phase 3
Locations
Iran, Islamic Republic of
Study Type
Interventional
Intervention
Cyclosporine-A
Sponsored by
About this trial
This is an interventional treatment trial for Autoimmune Hepatitis focused on measuring autoimmune hepatitis, corticosteroids, cysclosporine-A, treatment, treatment-naive, induction of remossion, efficacy, tolerability
Eligibility 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
Sites / Locations
- Digestive Disease Research Center, Shariati Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Group-A
Group-B
Arm Description
Treatment-naive AIH patients consenting to participate
Treatment-naive AIH patients consenting to participate. This group will receive Cyclosporine-A according to a set protocol.
Outcomes
Primary Outcome Measures
Remission
AST/ALT less than 2x UNL No clinical symptom
Treatment failure
Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol
Secondary Outcome Measures
Frequency of adverse events
Any adverse event (related or unrelated to the study drug) occuring during the induction phase.
Serious adverse event
Any adverse event requiring hospitalization or leading to disability or death
Full Information
NCT ID
NCT01170351
First Posted
July 24, 2010
Last Updated
July 17, 2019
Sponsor
Tehran University of Medical Sciences
1. Study Identification
Unique Protocol Identification Number
NCT01170351
Brief Title
Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis
Official Title
Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2013 (Actual)
Study Completion Date
December 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tehran University of Medical Sciences
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autoimmune Hepatitis
Keywords
autoimmune hepatitis, corticosteroids, cysclosporine-A, treatment, treatment-naive, induction of remossion, efficacy, tolerability
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
55 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group-A
Arm Type
Active Comparator
Arm Description
Treatment-naive AIH patients consenting to participate
Arm Title
Group-B
Arm Type
Experimental
Arm Description
Treatment-naive AIH patients consenting to participate. This group will receive Cyclosporine-A according to a set protocol.
Intervention Type
Drug
Intervention Name(s)
Cyclosporine-A
Intervention Description
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.
Primary Outcome Measure Information:
Title
Remission
Description
AST/ALT less than 2x UNL No clinical symptom
Time Frame
12 months
Title
Treatment failure
Description
Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Frequency of adverse events
Description
Any adverse event (related or unrelated to the study drug) occuring during the induction phase.
Time Frame
12 months
Title
Serious adverse event
Description
Any adverse event requiring hospitalization or leading to disability or death
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Digestive Disease Research Center, Shariati Hospital
City
Tehran
ZIP/Postal Code
14117
Country
Iran, Islamic Republic of
12. IPD Sharing Statement
Learn more about this trial
Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis
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