Conditions: Nonalcoholic Fatty Liver Disease (NAFLD)
Keywords: Nonalcoholic Fatty Liver Disease (NAFLD) Cysteamine bitartrate delayed release Children
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 169
Healthy volunteers: no

Brief 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.

Detailed description:

Arms:
arm 1: Active DR cysteamine bitartrate capsule arm 2: Placebo DR cysteamine bitartrate capsule

Interventions: intervention 1: DR cysteamine bitartrate capsule intervention 2: DR cysteamine bitartrate placebo
Intervention descriptions: intervention 1: * 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 intervention 2: * 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

Protocol document: