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Main
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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. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 February 2021 |
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Main ID: |
NCT02814110 |
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Date of registration:
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23/06/2016 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Efficacy Safety of Granulocyte Colony-stimulating Factor Treatment Children and Adolescents With Muscular Dystrophy
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Scientific title:
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Efficacy and the Safety of Granulocyte Colony-stimulating Factor Treatment in Children and Adolescents With Muscular Dystrophy: An Open Study |
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Date of first enrolment:
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March 1, 2013 |
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Target sample size:
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27 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02814110 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Poland
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Contacts
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Name:
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Wojciech Kulak, MD,PhD,Prof |
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Address:
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Telephone:
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Email:
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Affiliation:
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Medical University of Bialystok, Bialystok, Poland |
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Name:
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Wojciech Kulak, MD, PhD, Prof. |
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Address:
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Telephone:
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+48603512723 |
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Email:
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kneur2@wp.pl |
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Affiliation:
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Name:
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Wojciech Kulak, MD,PhD,Prof |
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Address:
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Telephone:
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+48603512723 |
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Email:
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kneur2@wp.pl |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Muscular dystrophy - Duchenne muscular dystrophy, Becker muscular dystrophy,
Fascioscapulohumeral dystrophy
- age 5-15
Exclusion Criteria:
- non- muscular dystrophy
- age below 5 years
- age over 15 years
Age minimum:
5 Years
Age maximum:
15 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Increase Muscle Strength in Patients With Muscular Dystrophy
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Intervention(s)
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Drug: Granulocyte colony-stimulating factor (Filgrastim)
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Primary Outcome(s)
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Safety based on number of participants with adverse events.
[Time Frame: Seven years]
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Secondary Outcome(s)
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Electrocardiographic records in patients with muscular dystrophy
[Time Frame: Seven years]
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Laboratory investigations in patients with muscular dystrophy
[Time Frame: Seven years]
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Muscle strength in patients with muscular dystrophy
[Time Frame: Seven years]
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Abdominal ultrasonography in patients with muscular dystrophy
[Time Frame: Seven years]
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Secondary ID(s)
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UMB 143-20899 P
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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