Trial Outcomes & Findings for A Preliminary Study to Evaluate Cysteamine Therapy in Human Subjects With Non-Alcoholic Steatohepatitis (NASH) (NCT NCT00799578)

Results Overview

Recruitment status

COMPLETED

Study phase

PHASE1/PHASE2

Target enrollment

13 participants

Primary outcome timeframe

6 months

Results posted on

2014-01-31

Biopsy proven children with nonalcoholic fatty liver disease from fatty liver clinic at University of California, San Diego

Not on other therapy for NAFLD

Withdrawal data not reported

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

Baseline characteristics by cohort
Measure	Cystagon-EC n=13 Participants
Age, Categorical <=18 years	13 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	14 years STANDARD_DEVIATION 1 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	12 Participants n=5 Participants
Region of Enrollment United States	13 participants n=5 Participants

Timeframe: 6 months

Outcome measures
Measure	Number of Improved Subjects n=11 Participants
Normalization or >50% of Serum ALT Levels From Baseline	7 participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Columbia University

Phone: 212 304 5533