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Note: This record shows only the 20 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.
Last refreshed on: 17 October 2012
Main ID:  NCT00443079
Date of registration: 02/03/2007
Primary sponsor: University of California, San Diego
Public title: A Study of Siliphos in Adults With Non-alcoholic Steatohepatitis (NASH)
Scientific title: A Single-center, Single-blinded, Placebo-controlled Pilot Study of IdB 1016 (Siliphos) in Adult Patients With Non-alcoholic Steatohepatitis (NASH)
Date of first enrolment: March 2007
Target sample size: 10
Recruitment status: Completed
Study type:  Interventional
Study design:  Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment  
Countries of recruitment
Key inclusion & exclusion criteria

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
Health Condition(s) or Problem(s) studied
Fatty Liver
Drug: IdB 1016 (Siliphos)
Primary Outcome(s)
Safety, as determined by laboratory and clinical assessment, during and after treatment [Time Frame: 4 months]
Tolerability, as determined by clinical assessment of side effects, during and after treatment [Time Frame: 4 months]
Secondary Outcome(s)
Efficacy, determined by serial measurement of serum aminotransferase levels before, during, and after treatment [Time Frame: 4 months]
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
American College of Gastroenterology
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