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A Natural History Study In Chinese Male Patients With Duchenne Muscular Dystrophy

NCT03760029 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 312

Last updated 2024-09-19

Study results available
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Summary

This is a multicenter, prospective, single cohort study designed to describe the natural history of DMD in Chinese male patients. A total of approximately 330 subjects will be enrolled with the target number of subjects in each group as below:

* Group 1, Ambulatory subjects aged \<6 years, approximately 100 subjects;
* Group 2, Ambulatory subjects aged \>=6 years, approximately 180 subjects;
* Group 3, Non-ambulatory subjects, approximately 50 subjects. Subjects will visit sites every 6 months. Each subject will be observed for at least 24 months. All subjects will remain enrolled until the study completion date, such that some will have data collected after Month 24. Subjects, who complete Visit 5/Month 24 at least 6 months prior to study completion, will be asked to complete an additional visit at Month 30.

Conditions

Interventions

OTHER

Visit frequency

All subjects need to visit sites more frequently than in routine clinical practice.

Sponsors & Collaborators

Principal Investigators

  • Pfizer CT.gov Call Center · Pfizer

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
0 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-24
Primary Completion
2023-03-21
Completion
2023-03-21

Countries

  • China

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03760029 on ClinicalTrials.gov