NCT03957720

The Individual Therapy for Patients With Wilson's Disease

• Status: Unknown
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

Based on the genotype characteristics and genotype-phenotype-treatment prognosis data of Chinese WD patients, this study intends to further optimize the treatment regimen of Chinese WD patients and formulate individualized treatment regimens for each genotype, so as to further improve the prognosis of patients.

Detailed description

The purpose of the study is to evaluate treatment regimen efficacy based on different mutations, and Zinc treatment in presymptomatic WD patients.

Conditions

• Wilson's Disease

Interventions

Type	Name	Description
DRUG	DMPS	Dosage Form: DMPS: 500-1000mg per day,DMPS Frequency:BID,DMPS Duration: 6 days;
DRUG	Penicillamine	Dosage Form: Penicillamine: 250-1500mg per day, Frequency:TID,Duration: 5 years;
DRUG	DMSA	Dosage Form: DMSA: 750-1000mg per day,DMSA Frequency:BID,DMSA Duration: 5 years; Dosage Form: DMSA: 35mg/kg per day,DMSA Frequency:BID,DMSA Duration: 5 years;
DRUG	Zinc gluconate	Dosage Form: Zinc gluconate: 140mg per time,Zinc Frequency:BID,Zinc Duration: 5 years; Dosage Form: Zinc gluconate: 140mg per time,Zinc Frequency:TID,Zinc Duration: 5 years; Dosage Form: Zinc gluconate: 210mg per time,Zinc Frequency:TID,Zinc Duration: 5 years;

Timeline

• Start date: 2019-03-15
• Primary completion: 2024-12-31
• Completion: 2024-12-31
• First posted: 2019-05-21
• Last updated: 2019-05-21

Locations

1 site across 1 country: China