Viewing Study NCT01529268

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Ignite Creation Date: 2025-12-24 @ 5:37 PM
Ignite Modification Date: 2025-12-28 @ 6:59 PM
Study NCT ID: NCT01529268
Status: COMPLETED
Last Update Posted: 2021-06-10
First Post: 2012-01-18
Is NOT Gene Therapy: True
Has Adverse Events: True
Brief Title: Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children
Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Organization:
Overview Dates Organization Conditions Design Enrollment Locations Outcomes Modules Raw JSON

Study Overview

Official Title: Cysteamine Bitartrate Delayed-Release for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Children (CyNCh)
Status: COMPLETED
Status Verified Date: 2017-08
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: CyNCh
Brief 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.
Detailed Description: None

Study Oversight

Has Oversight DMC: True
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?:

Secondary ID Infos

Secondary ID Type Domain Link View
U01DK061718 NIH None https://reporter.nih.gov/quic… View
U01DK061728 NIH None https://reporter.nih.gov/quic… View
U01DK061731 NIH None https://reporter.nih.gov/quic… View
U01DK061732 NIH None https://reporter.nih.gov/quic… View
U01DK061734 NIH None https://reporter.nih.gov/quic… View
U01DK061737 NIH None https://reporter.nih.gov/quic… View
U01DK061738 NIH None https://reporter.nih.gov/quic… View
U01DK061730 NIH None https://reporter.nih.gov/quic… View
U01DK061713 NIH None https://reporter.nih.gov/quic… View