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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT03957720
Date of registration:	08/04/2019
Prospective Registration:	No
Primary sponsor:	Second Affiliated Hospital, School of Medicine, Zhejiang University
Public title:	The Individual Therapy for Patients With Wilson's Disease
Scientific title:	The Individual Therapy for Patients With Wilson's Disease
Date of first enrolment:	March 15, 2019
Target sample size:	400
Recruitment status:	Recruiting
URL:	https://clinicaltrials.gov/show/NCT03957720
Study type:	Interventional
Study design:	Allocation: Non-Randomized. Intervention model: Sequential Assignment. Primary purpose: Treatment. Masking: Single (Participant).
Phase:	Early Phase 1

Countries of recruitment
China

Contacts

Name:	Zhi-Ying Wu, MD&PhD
Address:
Telephone:	+86-571-87783569
Email:	zhiyingwu@zju.edu.cn
Affiliation:

Name:	Zhi-Ying Wu, MD&PhD
Address:
Telephone:
Email:
Affiliation:	Zhejiang University

Name:	Zhi-Ying Wu, MD&PhD
Address:
Telephone:	+86-571-87783569
Email:	zhiyingwu@zju.edu.cn
Affiliation:

Key inclusion & exclusion criteria

Inclusion Criteria:

- Genetic diagnosis of Wilson's disease

- Presymptomatic patients with Wilson's disease

Exclusion Criteria:

- Movement disorder due to other definite causes instead of Wilson's disease

- Severe Lung, kidney or liver disease

- Neoplastic Disease

Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Wilson's Disease

Intervention(s)

Drug: DMPS

Drug: DMSA

Drug: Penicillamine

Drug: Zinc gluconate

Primary Outcome(s)

Cranial MRI scan [Time Frame: Five years]

Alanine transaminase [Time Frame: Five years]

bone mineral density test [Time Frame: Five years]

Abdominal ultrasound [Time Frame: Five years]

Unified Wilson's disease rating scale [Time Frame: Five years]

international normalized ratio [Time Frame: Five years]

Serum ceruloplasmin [Time Frame: Five years]

blood creatinine [Time Frame: Five years]

Platelet count [Time Frame: Five years]

24-hour urine copper [Time Frame: Five years]

hepatic fibrosis markers test [Time Frame: Five years]

serum copper [Time Frame: Five years]

urine protein level [Time Frame: Five years]

Urinary ultrasound [Time Frame: Five years]

White blood cell [Time Frame: Five years]

Secondary Outcome(s)

Secondary ID(s)

WuZYLab-WD

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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