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All Studies   Interventional Studies (Clinical Trials)  Observational Studies     -- Patient Registries   Expanded Access Studies   x

 

Expanded Access Type:

• Individual Patients
• Intermediate-size Population
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Age:  

x yearsOR

Age Group:  

Child (birth–17)
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Sex:  

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Accepts Healthy Volunteers:  

Healthy volunteers may participate in the study

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Phase:  

Early Phase 1	Phase 1	Phase 2
Phase 3	Phase 4	Not Applicable

Funder Type:  

NIH	Other U.S. Federal agency
Industry	All others (individuals, universities, organizations)

Study Documents:  

Study Protocols

Statistical Analysis Plans (SAPs)

Informed Consent Forms (ICFs)

FDAAA 801 Violations:  

FDAAA 801 Violations

Results Submitted:  

No Results Submitted Submitted, QC review not concluded --Submission with QC comments available x

Study Start:  

From x

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Primary Completion:  

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First Posted:  

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Results First Posted:  

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Last Update Posted:  

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