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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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16 December 2017 |
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Main ID: |
NCT02329769 |
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Date of registration:
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22/12/2014 |
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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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Open Label, Extension Study of PRO044 in Duchenne Muscular Dystrophy (DMD)
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Scientific title:
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A Phase II, Open Label, Extension Study to Assess the Effect of PRO044 in Patients With Duchenne Muscular Dystrophy |
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Date of first enrolment:
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December 2014 |
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Target sample size:
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15 |
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Recruitment status: |
Terminated |
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URL:
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https://clinicaltrials.gov/show/NCT02329769 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 2
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Countries of recruitment
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Belgium
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Italy
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Netherlands
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Sweden
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Subjects previously treated with PRO044.
2. Continued use of glucocorticoids for a minimum of 60 days prior to study entry with a
reasonable expectation that the subject will remain on steroids for the duration of
the study. Changes to the dose regimen or cessation of glucocorticoids will be at the
discretion of the Principle Investigator (PI) in consultation with the subject/parent
and the Medical Monitor. If the subject is not on steroids, involvement in the study
needs to be discussed with the medical monitor
Exclusion Criteria:
1. Current, or history of, liver or renal disease.
2. Acute illness within 4 weeks prior to the first dose of PRO044 (Week 1) which may
interfere with the measurements.
3. Severe cardiac myopathy which in the opinion of the Investigator prohibits
participation in this study
4. Need for daytime mechanical ventilation.
5. Screening aPTT above the upper limit of normal (ULN).
6. Screening platelet count below the lower limit of normal (LLN).
7. Use of anticoagulants, antithrombotics or antiplatelet agents.
8. Use of any investigational product within 6 months prior to the start of Screening for
the study.
9. Current or history of drug and/or alcohol abuse.
Age minimum:
9 Years
Age maximum:
20 Years
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Duchenne Muscular Dystrophy
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Intervention(s)
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Drug: PRO044 IV 9 mg/kg
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Drug: PRO044 SC 6 mg/kg
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Drug: PRO044 IV 6 mg/kg
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Primary Outcome(s)
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Safety and tolerability of PRO044 (treatement emergent adverse events)
[Time Frame: After 48 weeks of treatment]
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Efficacy of PRO044 (composite of several measures)
[Time Frame: After 48 weeks of treatment]
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Secondary Outcome(s)
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Assess the pharmacokinetics of PRO044 (composite of several measures)
[Time Frame: After 48 weeks of treatment]
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Secondary ID(s)
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PRO044-CLIN-02
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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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