Special Drug Use-Results Survey (All-Case Surveillance) to Investigate Safety and Effectiveness in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Received Empaveli in the Post-Marketing Clinical Use in Japan

Special Drug Use-Results Survey (All-Case Surveillance) to Investigate Safety and Effectiveness in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Received Empaveli in the Post-Marketing Clinical Use in Japan - PEG_PNH JPN PMS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

JPRN

Registry ID

JPRN-jRCT2031230275

Enrollment

100

Registered

2023-08-02

Start date

2023-11-06

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

Interventions

None listed

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: All patients with PNH who received Empaveli in Japan from the date of product launch to 31 May 2028 or until the approval conditions are lifted.

Exclusion criteria

Exclusion criteria: Not applicable.

Design outcomes

Primary

Measure	Time frame
Occurrence of the following adverse reactions: Hypersensitivity, Meningococcal infection, Infections (except meningococci), Serious hemolysis due to discontinuation of Empaveli.	—

Contacts

Public ContactClinical Study Manager

Swedish Orphan Biovitrum Japan Co., Ltd.

SobiJapanContact@sobi.com+81-3-4400-6872

Outcome results