NCT01529268

Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children

Cysteamine Bitartrate Delayed-Release for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Children (CyNCh)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 169 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions

Type	Name	Description
DRUG	DR cysteamine bitartrate capsule	* 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
OTHER	DR cysteamine bitartrate placebo	* 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

Timeline

• Start date: 2012-06-01
• Primary completion: 2015-03-01
• Completion: 2015-09-01
• First posted: 2012-02-08
• Last updated: 2021-06-10
• Results posted: 2017-09-05

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated drug study