NCT06606314

Specified Drug-use Surveillance of Fabhalta Capsules

Specified Drug-use Surveillance of Fabhalta Capsules (Paroxysmal Nocturnal Hemoglobinuria, CLNP023C11401)

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 0 Years – 100 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

• Paroxysmal Nocturnal Hemoglobinuria

Timeline

• Start date: 2024-09-18
• Primary completion: 2028-09-30
• Completion: 2028-09-30
• First posted: 2024-09-23
• Last updated: 2026-04-13

Locations

92 sites across 1 country: Japan