Patient Registry to Evaluate the Real-world Safety of Ruconest®

Pharming Healthcare

Status: Completed

Conditions: Hereditary Angioedema

Treatments: Drug: rhC1INH

Study type: Observational

Funder types: Industry; Other

Identifiers

NCT03697187

C1 1414

Details and patient eligibility

About

This is a prospective, real-world, observational patient registry for patients with HAE who are receiving treatment with Ruconest for HAE.

Full description

See below.

Enrollment: 152 patients

Sex: All

Ages: 13+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient provides informed consent as documented on the Institutional Review Board (IRB) approved informed consent document (ICF). For patients aged between 13 and 17 years old, the method of consent with or without assent will be determined by the IRB.
2. Patient is male or female and at least 13 years of age at the time of providing consent / assent.
3. Patient has been prescribed Ruconest for HAE.

Exclusion criteria

1. Patient is receiving HAE therapy as part of a clinical trial.

Trial design

152 participants in 1 patient group

Hereditary Angioedema

Description:

Patients with Hereditary Angioedema who are receiving treatment with Ruconest (rhC1INH).

Treatment:

Drug: rhC1INH