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Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks

A Phase 2, Randomized, Double-Blind, Multicenter, Dose-Ranging, Crossover Study to Evaluate the Safety and Efficacy of Subcutaneous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20) for the Prevention of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema

NCT01756157•Shire

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

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

Exclusion Criteria

•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.

Locations (23)

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

Key Dates

Start Date

February 4, 2013

Primary Completion Date

September 13, 2013

Completion Date

September 13, 2013

Last Updated

June 3, 2021

Enrollment

47

ACTUAL participants

Conditions

Hereditary Angioedema (HAE)

Interventions

CINRYZE with rHuPH20

BIOLOGICAL

Sponsors

Lead Sponsor

Shire

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 3, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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