At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
Cysteaminedrug
Likely dose
Cysteamine 1gfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Preliminary Study to Evaluate Cysteamine Therapy in Human Subjects With Non-Alcoholic Steatohepatitis (NASH)
In Brief
A Phase 2 clinical trial evaluating Cysteamine for Fatty Liver. Completed, enrolled 13 participants across 1 site.
Detailed Summary
The purpose of this study is to determine whether cysteamine will effectively reduce or reverse the biologic markers of steatohepatitis in patients.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsFatty Liver
CountriesUnited States
CollaboratorsRaptor Pharmaceuticals Corp.
Timeline
Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2008
First PostedDec 2008
Primary CompletionJun 2009
Study CompletionJan 2010
TodayJul 2026
First PostedDec 1, 2008
Enrollment StartOct 1, 2008
Primary CompletionJun 1, 2009
Study CompletionJan 1, 2010
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 17.6 years ago
Interventions
Cysteaminedrug
Drug is in enteric-coated capsule form. The dosage will begin at 1g/m-squared body surface area with a maximum dose of 1000mg twice daily. Treatment period is 3-6 months.