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

PHASE2/PHASE3CompletedINTERVENTIONAL
Enrollment

169

Participants

Timeline

Start Date

June 30, 2012

Primary Completion Date

March 31, 2015

Study Completion Date

September 30, 2015

Conditions
Nonalcoholic Fatty Liver Disease (NAFLD)
Interventions
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"

Trial Locations (10)

10032

Columbia University, New York

30322

Emory University, Atlanta

46202

Indiana University, Indianapolis

63104

St. Louis University, St Louis

77030

Texas Children's Hospital, Houston

92103

University of California, San Diego, San Diego

94143

University of California, San Francisco, San Francisco

98105

University of Washington, Seattle Children's Hospital, Seattle

60611-2605

Ann & Robert H. Lurie Children's Hospital of Chicago (NWU), Chicago

45229-3039

Cincinnati Children's Hospital Medical Center, Cincinnati

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

National Center for Advancing Translational Sciences (NCATS)

NIH

collaborator

National Cancer Institute (NCI)

NIH

collaborator

Raptor Pharmaceuticals

UNKNOWN

lead

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH