| Trial ID: | L0944 |
| Source ID: | NCT01529268
|
| Associated Drug: |
Cysteamine Bitartrate
|
| Title: |
Cysteamine Bitartrate Delayed-Release for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Children (CyNCh)
|
| Acronym: |
CyNCh
|
| Status: |
Not recruiting
|
| Study Results: |
Has Results
|
| Results: |
https://clinicaltrials.gov/ct2/show/results/NCT01529268
|
| Conditions: |
Nonalcoholic Fatty Liver Disease (NAFLD);Nonalcoholic Fatty Liver Disease (NAFLD);Nonalcoholic Fatty Liver Disease (NAFLD);Nonalcoholic Fatty Liver Disease (NAFLD)
|
| Interventions: |
Drug: DR cysteamine bitartrate capsule;Other: DR cysteamine bitartrate placebo;Drug: DR cysteamine bitartrate capsule;Other: DR cysteamine bitartrate placebo;Drug: DR cysteamine bitartrate capsule;Other: DR cysteamine bitartrate placebo;Drug: DR cysteamin
|
| Outcome Measures: |
Improvement in Nonalcoholic Fatty Liver Disease (NAFLD);Improvement in Nonalcoholic Fatty Liver Disease (NAFLD);Improvement in Nonalcoholic Fatty Liver Disease (NAFLD)Change in Nonalcoholic Fatty Liver Disease (NAFLD) Activity Score (NAS);Steatosis: Patients With Improvement;Steatosis: Change in Score;Lobular Inflammation: Patients With Improvement;Lobular Inflammation: Change in Score;Hepatocellular Ballooning: Patients With Improvement;Hepatocellular Ballooning: Change in Score;Portal Inflammation: Patients With Improvement;Portal Inflammation: Change in Score;Fibrosis: Patients With Improvement;Fibrosis: Change in Stage;Resolution of NASH;Change in Serum Aminotransferase and Gamma-glutamyl Transpeptidase;Change in Weight (kg);Change in Body-mass Index;Change in Body-mass Index Z-score;Change in Waist Circumference;Change in Fasting Serum Glucose;Change in Fasting Insulin;Change in HOMA-IR;Change in Systolic Blood Pressure;Change in Diastolic Blood Pressure;Change in Pediatric Quality of Life Inventory (PedsQL) Score;Reduction in MRI-determined Hepatic Fat Fraction
|
| Sponsor/Collaborators: |
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
|
| Gender: |
All
|
| Age: |
8 Years17 Years
|
| Phases: |
Phase 2/Phase 3
|
| Enrollment: |
169
|
| Study Type: |
Interventional
|
| Study Designs: |
Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
|
| Start Date: |
18/01/2012
|
| Completion Date: |
--
|
| Results First Posted: |
05/09/2017
|
| Last Update Posted: |
16 December 2017
|
| Locations: |
United States;United States;United States;United States;United States
|
| URL: |
https://clinicaltrials.gov/show/NCT01529268
|
