A Preliminary Study to Evaluate Cysteamine Therapy in Human Subjects With Non-Alcoholic Steatohepatitis (NASH)

Completed · Phase 1/Phase 2

Conditions studied: Fatty Liver

In brief

The purpose of this study is to determine whether cysteamine will effectively reduce or reverse the biologic markers of steatohepatitis in patients.

Key facts

Study ID

NCT00799578

Run by

Joel Lavine

People needed

13

Starts

2008-10-01

Expected to finish

2010-01-01

Last updated by the study team

2014-01-31

Who can join

Age: 10 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• University of California, San Diego School of Medicine General Clinic Research Center — San Diego, California, United States

Full record on ClinicalTrials.gov

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