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NCT01529268 · ClinicalTrials.gov registry record · Phase 2
Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 169
- Enrollment target
NCT01529268: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT01529268 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 169 participants, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01529268, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 169 participants
- Enrollment target
Study 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.
Primary Outcome
Centrally scored and masked assessment of histologic improvement in Nonalcholic Fatty Liver Disease (NAFLD) between the baseline liver biopsy and follow-up biopsy after 52 weeks of treatment, where improvement is defined as: (1) decrease in the NAFLD Activity Score (NAS) of 2 or more and (2) no worsening of fibrosis.
Interventions
- DRUG DR cysteamine bitartrate capsule
- OTHER DR cysteamine bitartrate placebo
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 169 participants |
| Start Date | 2012-06 |
| Est. Completion | 2015-09 |
| Phase | Phase 2 |
What the finished NCT01529268 record still lists
NCT01529268 is an interventional study that assigns participants to a tested intervention. The registered 169 participants enrollment target is mid-sized for trials with a published cap, above the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 2 interventions - of which DR cysteamine bitartrate capsule is the first listed.
NCT01529268 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01529268 about?
NCT01529268 is a clinical study titled "Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children". 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 res...
What is the current status of trial NCT01529268?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 169 participants. The study started on 2012-06. Estimated completion is 2015-09.
What interventions are being tested in trial NCT01529268?
The interventions under investigation include: DR cysteamine bitartrate capsule (DRUG), DR cysteamine bitartrate placebo (OTHER).
Who is sponsoring clinical trial NCT01529268?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01529268's enrollment target sits among peer trials
169 403rd of 2000 higher than 1,598 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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