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

Last updated: April 3, 2024
Sponsor: Pharming Technologies B.V.
Overall Status: Completed

Phase

N/A

Condition

Allergies & Asthma

Urticaria

Hives (Urticaria)

Treatment

rhC1INH

Clinical Study ID

NCT03697187
C1 1414
  • Ages > 13
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

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 17years 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 providingconsent / assent.
  3. Patient has been prescribed Ruconest for HAE.

Exclusion

Exclusion Criteria:

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

Study Design

Total Participants: 152
Treatment Group(s): 1
Primary Treatment: rhC1INH
Phase:
Study Start date:
June 30, 2018
Estimated Completion Date:
July 31, 2021

Study Description

See below.

Connect with a study center

  • The US Hereditary Angioedema Association

    Fairfax, Virginia 22030
    United States

    Site Not Available

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