A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor

Last updated: November 7, 2017
Sponsor: Pharming Technologies B.V.
Overall Status: Completed

Phase

2

Condition

Hereditary Angioedema

Hives (Urticaria)

Urticaria

Treatment

N/A

Clinical Study ID

NCT02247739
C1 3201
  • Ages > 13
  • All Genders

Study Summary

Primary Objective:

To evaluate the efficacy of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE

Secondary Objective:

To evaluate the safety and immunogenicity of recombinant human C1 inhibitor (rhC1INH) in the prophylaxis of angioedema attacks in patients with HAE

Eligibility Criteria

Inclusion

Inclusion Criteria: Patients fulfilling the following criteria at Screening are eligible for participation inthe study:

  1. Age 13 years or older

  2. Laboratory confirmed diagnosis of HAE

  3. A history of frequent HAE attacks (at least 4 attacks per month across a minimum of 3consecutive months).

  4. Female patients of childbearing potential who are sexually active must be willing touse an acceptable form of contraception.

  5. Provided written informed consent (and written assent for minors)

  6. Willingness and ability to comply with all protocol procedures

Exclusion

Exclusion Criteria: Patients who meet any of the following criteria at Screening are to be excluded from studyparticipation:

  1. Patients with medical history of allergy to rabbits or rabbit-derived products (including rhC1INH)

  2. Diagnosis of acquired angioedema (AAE)

  3. Patients who are pregnant, or breastfeeding, or are currently intending to becomepregnant

  4. Treatment with any investigational drug in the past 30 days

  5. Patients with any condition or treatment that, in the opinion of the Investigator,might interfere with the evaluation of study objectives

  6. Patients currently treated with angiotensin-converting enzyme (ACE) inhibitors

Study Design

Total Participants: 32
Study Start date:
December 01, 2014
Estimated Completion Date:
September 30, 2016

Study Description

Study Design:

This is a multi-center, randomized, double-blind, placebo-controlled, 3-period crossover study of rhC1INH in prophylaxis of angioedema attacks in patients with HAE.

Medical screening (clinical and laboratory parameters) will be performed and patient medical history specific to HAE attacks will be collected to assess eligibility. Each patient will receive three 4 week periods of treatment twice weekly.

Connect with a study center

  • Ottawa Allergy Research Corp

    Ottawa, Ontario K1G6C6
    Canada

    Site Not Available

  • Faculty Hospital by St. Anna Brno, Department of clinical Immunology and Allergology

    Brno, 65691
    Czechia

    Site Not Available

  • Azienda Ospedaliera Universitaria Luigi Sacco Di Milano

    Milan, 20157
    Italy

    Site Not Available

  • PHI University Clinic of Dermatology

    Skopje, 1000
    Macedonia, The Former Yugoslav Republic of

    Site Not Available

  • Pharming Technologies BV

    Leiden, 233 CR
    Netherlands

    Site Not Available

  • SC Centrul Clinic Mediquest SRL

    Singeorgiu de Mures, Mures 547530
    Romania

    Site Not Available

  • SC Centrul Clinic Mediquest SRL

    Sângeorgiu de Mureş, Mures 547530
    Romania

    Site Not Available

  • Clinical Center Serbia

    Belgrade,
    Serbia

    Site Not Available

  • University of South Florida Asthma, Allergy and Immunology Clinical Research Unit

    Tampa, Florida 33613
    United States

    Site Not Available

  • University of South Florida, Asthma, Allergy & Immunology Clinical Research Unit

    Tampa, Florida 33613
    United States

    Site Not Available

  • Washington University Division of Allergy and Immunology

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • Washington University Division of Allergy and Immunology

    St. Louis, Missouri 63141
    United States

    Site Not Available

  • Baker Allergy, Asthma and Dermatology Research Center

    Lake Oswego, Oregon 97035
    United States

    Site Not Available

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