At a glance
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Cysteamine Bitartrate Delayed-Release for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Children (CyNCh)
In Brief
A Phase 3 clinical trial evaluating DR cysteamine bitartrate capsule and DR cysteamine bitartrate placebo for Nonalcoholic Fatty Liver Disease (NAFLD). Completed, enrolled 169 participants across 10 sites.
Detailed Summary
CyNCh is a multi-center, placebo-controlled clinical trial of children ages 8 to 17 years with biopsy-confirmed moderate to severe nonalcoholic fatty liver disease (NAFLD). The primary objective is to evaluate whether 52 weeks of treatment with cysteamine bitartrate delayed-release capsules will result in improvement in liver disease severity.
Study Details
Timeline
Interventions
* 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline * 750 mg/day (five 75 mg capsules twice daily) for patients \>65 - 80 kg at baseline * 900 mg/day (six 75 mg capsules twice daily) for patients \>80 kg at baseline
* 600 mg/day (four 75 mg capsules twice daily) for patients ≤ 65 kg at baseline * 750 mg/day (five 75 mg capsules twice daily) for patients \>65 - 80 kg at baseline * 900 mg/day (six 75 mg capsules twice daily) for patients \>80 kg at baseline