clinical trial · NCT06606314
Specified Drug-use Surveillance of Fabhalta Capsules
Paroxysmal Nocturnal Hemoglobinuria
brief summary
This is a multicenter, single-arm, non-interventional study (NIS) with a central registration system and an all-case surveillance system. The observation period is 48 weeks after the start of treatment with Fabhalta.
started
Sep 18, 2024
primary completion
Sep 30, 2028
completion
Sep 30, 2028
last updated
Apr 13, 2026
detailed description
The observation period will be 48 weeks after the start of treatment with Fabhalta.
For patients in whom treatment with Fabhalta is discontinued within 48 weeks after the start of the treatment, adverse events occurring by the last day of the treatment + 30 days and concomitant drugs will be monitored and recorded in CRFs.
official title
Specified Drug-use Surveillance of Fabhalta Capsules (Paroxysmal Nocturnal Hemoglobinuria, CLNP023C11401)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol