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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT00443079 |
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Date of registration:
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02/03/2007 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH)
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Scientific title:
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A Single-center, Single-blinded, Placebo-controlled Pilot Study of IdB 1016 (Siliphos) in Adult Patients With Non-alcoholic Steatohepatitis (NASH) |
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Date of first enrolment:
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March 2007 |
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Target sample size:
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10 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00443079 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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United States
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Contacts
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Name:
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Heather M Patton, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of California, San Diego |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Liver biopsy within 12 months demonstrating NASH
- Abnormal ALT
Exclusion Criteria:
- Uncontrolled diabetes
- Hepatitis B, hepatitis C, or other chronic liver conditions
- Abnormal kidney function
- Excess alcohol consumption
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Fatty Liver
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Intervention(s)
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Drug: IdB 1016 (Siliphos)
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Primary Outcome(s)
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Safety, as determined by laboratory and clinical assessment, during and after treatment
[Time Frame: 4 months]
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Tolerability, as determined by clinical assessment of side effects, during and after treatment
[Time Frame: 4 months]
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Secondary Outcome(s)
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Efficacy, determined by serial measurement of serum aminotransferase levels before, during, and after treatment
[Time Frame: 4 months]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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