Post-marketing Surveillance Protocol Number; CLNP023C11401

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031240379

Enrollment

110

Registered

2024-10-07

Start date

2024-08-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Paroxysmal nocturnal hemoglobinuria(PNH)

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients who received Fabhalta.

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Occurrence status of infections. Type, incidence, seriousness, severity, clinical course, factors affecting onset (status of vaccination, name of vaccine administered, complications, baseline white blood cell count/neutrophil count, etc.), and causative organism (including serotype) of adverse events/adverse drug reactions of infections during the treatment period.	—

Contacts

Public ContactNovartis Direct

Novartis Pharma. K.K.

sm.pms@novartis.com+81-120-003-293

Outcome results