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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04012671
Other study ID # MRCTA,ECFAH of FMU [2019]193
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date December 31, 2049

Study information

Verified date February 2021
Source First Affiliated Hospital of Fujian Medical University
Contact Ning Wang, MD, PhD
Phone 13805015340
Email ningwang@fjmu.edu.cn
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Dystrophinopathy is a term of X-linked recessive genetic disease, including Duchenne Muscular Dystrophy, Becker Muscular Dystrophy, and the X-linked dilated cardiomyopathy. The aim of this study is to determine the clinical spectrum and natural progression of dystrophinopathy in a prospective multicenter natural history study, to assess the clinical, genetic of patients with dystrophinopathy to optimize clinical management.


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date December 31, 2049
Est. primary completion date December 31, 2039
Accepts healthy volunteers No
Gender All
Age group 2 Years and older
Eligibility Inclusion Criteria: - Beyond 2 years old - Diagnosis with Duchenne Muscular Dystrophy, and female carriers, genotypically confirmed - Diagnosis should be supported by muscle biopsy, if no genetic confirmation. Exclusion Criteria: - Presence of other clinically significant illness

Study Design


Locations

Country Name City State
China First Affiliated Hospital of Fujian Medical University Fuzhou

Sponsors (1)

Lead Sponsor Collaborator
Ning Wang, MD., PhD.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Age at death the time when patient die 20 years
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