Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks

Completed · Phase 2

Conditions studied: Hereditary Angioedema (HAE)

In brief

The primary objectives of the study are to evaluate the safety, tolerability, and efficacy of two doses of CINRYZE with recombinant human hyaluronidase (rHuPH20) administered by subcutaneous (SC) injection to prevent angioedema attacks.

Key facts

Study ID

NCT01756157

Run by

Shire

People needed

47

Starts

2013-02-04

Expected to finish

2013-09-13

Last updated by the study team

2021-06-03

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Be ≥12 years of age.
• Have a confirmed diagnosis of Hereditary Angioedema.

You may not qualify if…

• Receipt of any C1 inhibitor (C1 INH) therapy or any blood products for treatment or prevention of an angioedema attack within 7 days before the first dose of study drug.
• Be receiving prophylactic intravenous CINRYZE that exceeds 1000 units every 3 or 4 days (maximum weekly dose 2000 units).
• Have received any androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 7 days prior to the first dose of study drug.
• If female, have started taking or changed the dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progestin containing products) within 3 months prior to the first dose of study drug.
• History of allergic reaction to C1 INH products, including CINRYZE or other blood products.
• History of abnormal blood clotting.
• Have a known allergy to hyaluronidase or any other ingredient in the study formulation.

Where it is running

• ViroPharma Investigational Site — Birmingham, Alabama, United States
• ViroPharma Investigational Site — Scottsdale, Arizona, United States
• ViroPharma Investigational Site — Bentonville, Arkansas, United States
• ViroPharma Investigational Site — Walnut Creek, California, United States
• ViroPharma Investigational Site — Colorado Springs, Colorado, United States
• ViroPharma Investigational Site — Tampa, Florida, United States
• ViroPharma Investigational Site — Boston, Massachusetts, United States
• ViroPharma Investigational Site — Las Vegas, Nevada, United States
• ViroPharma Investigational Site — Mineola, New York, United States
• ViroPharma Investigational Site — Cincinnati, Ohio, United States
• ViroPharma Investigational Site — Columbus, Ohio, United States
• ViroPharma Investigational Site — Lake Oswego, Oregon, United States
• ViroPharma Investigational Site — Hershey, Pennsylvania, United States
• ViroPharma Investigational Site — Pittsburgh, Pennsylvania, United States
• ViroPharma Investigational Site — Knoxville, Tennessee, United States
• ViroPharma Investigational Site — Dallas, Texas, United States
• ViroPharma Investigational Site — Spokane, Washington, United States
• ViroPharma Investigational Site — Berlin, Germany
• ViroPharma Investigational Site — Essen, Germany
• ViroPharma Investigational Site — Mainz, Germany
• ViroPharma Investigational Site — München, Germany
• ViroPharma Investigational Site — Barcelona, Spain
• ViroPharma Investigational Site — Jönköping, Sweden

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.