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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 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.

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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.

Interventions

  • DRUG DR cysteamine bitartrate capsule
  • OTHER DR cysteamine bitartrate placebo

Trial Details

FieldValue
Enrollment Target 169 participants
Start Date 2012-06
Est. Completion 2015-09
Phase Phase 2

What the Registry Record Tells You About NCT01529268

The ClinicalTrials.gov registry entry for NCT01529268 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 169 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which DR cysteamine bitartrate capsule is the first listed.

NCT01529268 reports 0 study locations.

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.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.