Clinical trialNCT01529268CompletedPhase 2/PHASE3Interventional

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

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)Enrollment169Nonalcoholic Fatty Liver Disease (NAFLD)

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

Edward Doo, MD
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

University of California, San Diego
San Diego, California, United States
University of California, San Francisco
San Francisco, California, United States
Emory University
Atlanta, Georgia, United States
Ann & Robert H. Lurie Children'S Hospital of Chicago (nwu)
Chicago, Illinois, United States
Indiana University
Indianapolis, Indiana, United States
St. Louis University
St Louis, Missouri, United States
Columbia University
New York, New York, United States
Cincinnati Children'S Hospital Medical Center
Cincinnati, Ohio, United States
Texas Children'S Hospital
Houston, Texas, United States
University of Washington, Seattle Children'S Hospital
Seattle, Washington, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

DR cysteamine bitartrate capsule

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Jun 2012
Primary completion: 31 Mar 2015
Completion: 30 Sept 2015
Last update posted: 10 Jun 2021
Registered enrollment: 169
Registry id: NCT01529268

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.