Study of Zinc for Wilson Disease

Status Completed

Clinical Trial Summary

OBJECTIVES: I. Establish the safety and efficacy of extended maintenance zinc therapy in 200 patients with Wilson disease.

II. Establish further the role of zinc in the prophylactic treatment of presymptomatic patients by increasing the current cohort from 80 to at least 100 patients.

III. Establish further the role of zinc therapy in pregnant patients with Wilson disease.

IV. Establish further the role of zinc therapy in children with Wilson disease.

Clinical Trial Description

PROTOCOL OUTLINE:

Patients receive copper regulation therapy with zinc acetate: an existing cohort on maintenance therapy will be followed for long-term data collection; presymptomatic patients are treated prophylactically; and pregnant patients are evaluated for fetal outcome. All patients are evaluated for copper balance, clinical control, and toxicity. ;

Study Design

Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment

Related Conditions & MeSH terms

Wilson Disease

Clinical Trial Details

NCT number	NCT00004338
Study type	Interventional
Source	National Center for Research Resources (NCRR)
Contact
Status	Completed
Phase	Phase 4
Start date	October 1993

View Details

See also
Status	Clinical Trial	Phase
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Completed	`NCT03539952` - Trientine Tetrahydrochloride (TETA 4HCL) for the Treatment of Wilson's Disease	Phase 3
Active, not recruiting	`NCT04884815` - Study of UX701 Gene Transfer for the Treatment of Wilson Disease	Phase 1/Phase 2
Not yet recruiting	`NCT03659331` - A Controlled Study of Potential Therapeutic Effect of Oral Zinc in Manifesting Carriers of Wilson Disease	N/A
Recruiting	`NCT05687474` - Baby Detect : Genomic Newborn Screening
Completed	`NCT04965571` - Clinical Features and Outcome of Wilson's Disease With Generalized Epilepsy in Chinese Patients
Terminated	`NCT05047523` - Study of ALXN1840 Versus Standard of Care in Pediatric Participants With Wilson Disease	Phase 3
Completed	`NCT04526210` - Study of ALXN1840 on the Metabolism of a CYP2B6 Substrate in Healthy Participants	Phase 1
Enrolling by invitation	`NCT03655223` - Early Check: Expanded Screening in Newborns
Completed	`NCT02273596` - Efficacy and Safety Study of WTX101 (ALXN1840) in Adult Wilson Disease Patients	Phase 2
Completed	`NCT02763215` - The Assessment of Copper Parameters in Wilson Disease Participants on Standard of Care Treatment
Recruiting	`NCT05444127` - Oral Health and Wilson's Disease: SOMAWI
Completed	`NCT04408300` - Study of Retinal Vascular Parameters in Patients With Wilson's Disease	N/A
Active, not recruiting	`NCT05783687` - Real World Evidence Study in Subjects With Wilson's Disease
Terminated	`NCT04909346` - Adeno-Associated Virus (AAV) Antibody Study in Subjects OTC Deficiency, GSDIa, and Wilson Disease
Completed	`NCT03867526` - Establishment of Human Cellular Disease Models for Wilson Disease
Enrolling by invitation	`NCT03589820` - Plasma Exchange and Continuous Hemodiafiltration in Treatment of Wilson's Disease-related Liver Failure	N/A
Completed	`NCT04526197` - Phase 1 Study of ALXN1840 on the Metabolism of a CYP2C9 Substrate in Healthy Participants.	Phase 1
Not yet recruiting	`NCT06430359` - Circadian Variation of Urinary Copper Excretion in Wilson Disease Patients
Completed	`NCT04910581` - rTMS in Wilson Disease Dysarthria	N/A