Status:
RECRUITING
Specified Drug-use Surveillance of Fabhalta Capsules
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Paroxysmal Nocturnal Hemoglobinuria
Eligibility:
All Genders
Up to 100 years
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 treatmen...
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, adve...
Eligibility Criteria
Inclusion
- All patients who received Fabhalta.
- ·
Exclusion
- Patients receiving Fabhalta for an unapproved indication under the Clinical Trials Act or GCP.
Key Trial Info
Start Date :
September 18 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 30 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06606314
Start Date
September 18 2024
End Date
September 30 2028
Last Update
December 30 2025
Active Locations (74)
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1
Novartis Investigative Site
Handa, Aichi-ken, Japan, 475-0817
2
Novartis Investigative Site
Nagoya, Aichi-ken, Japan, 453-8511
3
Novartis Investigative Site
Okazaki, Aichi-ken, Japan, 444-8553
4
Novartis Investigative Site
Toyohashi, Aichi-ken, Japan, 441-8570