A Phase 2 HAE Prophylaxis Study With Recombinant Human C1 Inhibitor

Completed · Phase 2 · Has a placebo group

Conditions studied: Hereditary Angioedema

In brief

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

Key facts

Study ID

NCT02247739

Run by

Pharming Technologies B.V.

People needed

32

Starts

2014-12-01

Expected to finish

2016-09-01

Last updated by the study team

2017-12-08

Who can join

Age: 13 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients fulfilling the following criteria at Screening are eligible for participation in the study:
• Age 13 years or older
• Laboratory confirmed diagnosis of HAE
• A history of frequent HAE attacks (at least 4 attacks per month across a minimum of 3 consecutive months).
• Female patients of childbearing potential who are sexually active must be willing to use an acceptable form of contraception.
• Provided written informed consent (and written assent for minors)
• Willingness and ability to comply with all protocol procedures

You may not qualify if…

• Patients who meet any of the following criteria at Screening are to be excluded from study participation:
• Patients with medical history of allergy to rabbits or rabbit-derived products (including rhC1INH)
• Diagnosis of acquired angioedema (AAE)
• Patients who are pregnant, or breastfeeding, or are currently intending to become pregnant
• Treatment with any investigational drug in the past 30 days
• Patients with any condition or treatment that, in the opinion of the Investigator, might interfere with the evaluation of study objectives
• Patients currently treated with angiotensin-converting enzyme (ACE) inhibitors

Where it is running

• University of South Florida Asthma, Allergy and Immunology Clinical Research Unit — Tampa, Florida, United States
• University of South Florida, Asthma, Allergy & Immunology Clinical Research Unit — Tampa, Florida, United States
• Washington University Division of Allergy and Immunology — St Louis, Missouri, United States
• Baker Allergy, Asthma and Dermatology Research Center — Lake Oswego, Oregon, United States
• Ottawa Allergy Research Corp — Ottawa, Ontario, Canada
• Faculty Hospital by St. Anna Brno, Department of clinical Immunology and Allergology — Brno, Czechia
• Azienda Ospedaliera Universitaria Luigi Sacco Di Milano — Milan, Italy
• PHI University Clinic of Dermatology — Skopje, North Macedonia
• SC Centrul Clinic Mediquest SRL — Sângeorgiu de Mureş, Mureș County, Romania
• Clinical Center Serbia — Belgrade, Serbia

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.