Phase 2 Completed N=13 Treatment

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

fatty liver

Source: ClinicalTrials.gov NCT00799578 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Jan 2014

Primary outcomePrimary: Normalization or >50% of Serum ALT Levels From Baseline — 7 participants

Summary

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

Outcome Measures

Outcome	Result	p-value
PRIMARY Normalization or >50% of Serum ALT Levels From Baseline	7	—

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00799578). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.