Phase 2
N=13
A Preliminary Study to Evaluate Cysteamine Therapy in Human Subjects With Non-Alcoholic Steatohepatitis (NASH)
Fatty Liver
Bottom Line
View on ClinicalTrials.gov: NCT00799578 ↗Enrolled (actual)
13
Serious AEs
0.0%
Results posted
Jan 2014
Primary outcome: Primary: Normalization or >50% of Serum ALT Levels From Baseline — 7 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cysteamine (Drug)
- Age
- Pediatric, Adult, Older Adult · 10+ yrs
- Sex
- All
- Sponsor
- Joel Lavine
- Primary completion
- Jun 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normalization or >50% of Serum ALT Levels From Baseline |
7 | — |
Summary
The purpose of this study is to determine whether cysteamine will effectively reduce or reverse the biologic markers of steatohepatitis in patients.
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.
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.