Specified Drug-use Surveillance of Fabhalta Capsules

Novartis

Status: Enrolling

Conditions: Paroxysmal Nocturnal Hemoglobinuria

Study type: Observational

Funder types: Industry

Identifiers

NCT06606314

CLNP023C11401

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: Under 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

All patients who received Fabhalta.

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Exclusion criteria

Patients receiving Fabhalta for an unapproved indication under the Clinical Trials Act or GCP.