Phase I Study of Orally Administered Aminolevulinic Acid for Resection of Malignant Astrocytomas
Interventional
Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
serious adverse event (SAE) Rate
It will be considered as a serious adverse event with possible, probable, and definitely attribution to 5-ALA (SAE, detailed in section 8) if (within 2 weeks of dosing): Grade 1 or 2 LFT abnormalities not resolving within 2 weeks A single documented Grade 3 or 4 LFT abnormalities A Grade 3 or 4 skin photosensitivity
2 weeks from dosing
Yes
United States: Food and Drug Administration
J1140
NCT01502605
Name | Location |
---|---|
Johns Hopkins Hospital | Baltimore, Maryland 21287 |