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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

152 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-06-30

Study Completion Date

2021-07-31

Brief Summary

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

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Detailed Description

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See below.

Conditions

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Hereditary Angioedema

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Hereditary Angioedema

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

rhC1INH

Intervention Type DRUG

Recombinant human C1 inhibitor

Interventions

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rhC1INH

Recombinant human C1 inhibitor

Intervention Type DRUG

Other Intervention Names

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Ruconest

Eligibility Criteria

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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.