Study identification

EU PAS number

EUPAS1000000702

Study ID

1000000702

Official title and acronym

A Post-Authorization Safety Study (Pass) to Characterize Safety Events and Special Conditions, Such as Pregnancy and Infant Outcomes, in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Treated With Crovalimab Within the IPIG Registry

DARWIN EU® study

No

Study countries

Belgium
Canada
France
Germany
Italy
Korea, Republic of
Netherlands
Spain
United Kingdom
United States

Study description

This study is a multi-center, multi-country, non-interventional, registry-based PASS using secondary data collected as part of the Crovalimab Silo registry (Study MO44987) of participants with PNH exposed to crovalimab, including pregnant women and their infants.

The Crovalimab Silo will encompass retrospective and prospective data from all enrolled participants treated with crovalimab including patients’ characteristics and clinical outcomes (including safety data, pregnancy and infant outcomes, and breastfeeding), and crovalimab exposure.

Study status

Planned
Research institutions and networks

Institutions

Contact details

Felipe Castro

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:

Study start date

Planned:

Data analysis start date

Planned:

Date of interim report, if expected

Planned:

Date of final study report

Planned:
Sources of funding
Pharmaceutical company and other private sector 

More details on funding

Hoffmann-La Roche
Regulatory

Was the study required by a regulatory body?

Yes

Is the study required by a Risk Management Plan (RMP)?

EU RMP category 3 (required)