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

• Status: Completed
• Trial end date: 2010-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Joel Lavine
• Collaborator: Raptor Pharmaceuticals Corp.
• Treatments: Cysteamine

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.