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Cysteamine Bitartrate Delayed-Release for the Treatment of NAFLD in Children | Clinical Trials | Clareo Health

COMPLETEDPHASE2/PHASE3

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

Cysteamine Bitartrate Delayed-Release for the Treatment of Nonalcoholic Fatty Liver Disease (NAFLD) in Children (CyNCh)

NCT01529268•National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

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.

Eligibility

Age

8 - 17 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Children age 8-17 years
•Liver biopsy obtained within 90 days of screening visit and not more than 120 days before randomization
•Clinical history consistent with nonalcoholic fatty liver disease (NAFLD)
•Definite NAFLD based upon liver histology
•No evidence of any other liver disease by clinical history or histological evaluation
•A histological severity of: NAFLD Activity Score (NAS) ≥ 4.
•Sexually active female participants of childbearing potential (i.e., not surgically sterile \[defined as tubal ligation, hysterectomy, or bilateral oophorectomy\]) must agree to utilize the same two acceptable forms of contraception from screening through completion of the study and to complete a serum pregnancy test at each study visit. The acceptable forms of contraception for this study include hormonal contraceptives (oral, implant, transdermal patch, or injection) at a stable dose for at least 3 months prior to screening, and barrier (condom with spermicide, diaphragm with spermicide). Sexual activity will be ascertained at each study visit for post-menarchal females and if sexually active, subject must verify use of the same 2 acceptable forms of contraception. For pre-pubescent children, a documented attestation of abstinence from their parent or guardian will be acceptable.
•Participants must be able to swallow DR Cysteamine tablets with the tablet intact
•Written informed consent from parent or legal guardian
•Written informed assent from the child

Exclusion Criteria

•Participants with a current history of the following conditions or any other health issues that make it unsafe for them to participate in the opinion of the Investigators:
•* Inflammatory bowel disease (if currently active) or prior resection of small intestine
•* Heart disease (e.g., myocardial infarction, heart failure, unstable arrhythmias)
•* Seizure disorder
•* Active coagulopathy
•* Gastrointestinal ulcers/bleeding
•* Renal dysfunction with a creatinine clearance \< 90 mL/min/m2
•* History of active malignant disease requiring chemotherapy within the past 12 months prior to randomization
•* History of significant alcohol intake (AUDIT questionnaire) or inability to quantify alcohol consumption
•* Chronic use (more than 2 consecutive weeks) of medications known to cause hepatic steatosis or steatohepatitis (systemic glucocorticoids, tetracycline, anabolic steroids, valproic acid, salicylates, tamoxifen) in the past year.
+26 more criteria

Locations (10)

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

Key Dates

Start Date

June 1, 2012

Primary Completion Date

March 1, 2015

Completion Date

September 1, 2015

Last Updated

June 10, 2021

Enrollment

169

ACTUAL participants

Conditions

Nonalcoholic Fatty Liver Disease (NAFLD)

Interventions

DR cysteamine bitartrate capsule

DRUG

DR cysteamine bitartrate placebo

OTHER

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 10, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

A Prospective, Randomized, Placebo-Controlled Pilot Study to Characterize the Intestinal Microbiome and to Evaluate the Safety and Fecal Microbiome Changes Following Administration of Lyophilized PRIM-DJ2727 or Placebo Given Orally in Subjects With Nonalcoholic Fatty Liver Disease

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