Status:
COMPLETED
A Preliminary Study to Evaluate Cysteamine Therapy in Human Subjects With Non-Alcoholic Steatohepatitis (NASH)
Lead Sponsor:
Joel Lavine
Collaborating Sponsors:
Raptor Pharmaceuticals Corp.
Conditions:
Fatty Liver
Eligibility:
All Genders
10+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to determine whether cysteamine will effectively reduce or reverse the biologic markers of steatohepatitis in patients.
Detailed Description
Non-alcoholic fatty liver disease (NAFLD) steatohepatitis represents a spectrum of disease occurring in the absence of alcohol abuse. It is characterized by the presence of steatosis and may represent...
Eligibility Criteria
Inclusion
- Biopsy confirmed diagnosis of non-alcoholic steatohepatitis (within past 12 months)
- Ages 10 yrs and older
- Must swallow tablets on a regular basis
- ALT level \>60 iu/L
Exclusion
- Subjects with known hypersensitivity to cysteamine
- History, currently or within the past 3 months, of the following conditions:
- Pancreatitis
- Inflammatory bowel disease
- Malabsorption
- Unstable heart disease, e.g., myocardial infarction, heart failure, arrhythmias.
- Unstable diabetes mellitus
- Any bleeding disorder.
- Zollinger-Ellison syndrome
- Malignant disease
- Subjects whom maybe pregnant or have health issues that make it unsafe for them participate, or whose concomitant medical problems preclude them from committing to the study schedule.
- No specific NASH medical therapy for 3 months such as vitamin E, s-adenosyl methionine or metformin or other NAFLD study drugs.
Key Trial Info
Start Date :
October 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2010
Estimated Enrollment :
13 Patients enrolled
Trial Details
Trial ID
NCT00799578
Start Date
October 1 2008
End Date
January 1 2010
Last Update
January 31 2014
Active Locations (1)
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1
University of California, San Diego School of Medicine General Clinic Research Center
San Diego, California, United States, 92103-8203