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Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks

NCT ID: NCT01756157

Last Updated: 2021-06-03

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-04

Study Completion Date

2013-09-13

Brief Summary

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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.

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A Study to Evaluate the Safety and Effect of Escalating Doses of CINRYZE

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Detailed Description

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Conditions

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Hereditary Angioedema (HAE)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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SC CINRYZE with rHuPH20 Dose Level 1 followed by Dose Level 2

SC CINRYZE with rHuPH20 Dose Level 1 twice weekly (every 3 or 4 days) for 8 weeks followed by SC CINRYZE with rHuPH20 Dose Level 2 twice weekly (every 3 or 4 days) for 8 weeks.

Group Type EXPERIMENTAL

CINRYZE with rHuPH20

Intervention Type BIOLOGICAL

SC CINRYZE with rHuPH20 Dose Level 2 followed by Dose Level 1

SC CINRYZE with rHuPH20 Dose Level 2 twice weekly (every 3 or 4 days) for 8 weeks followed by SC CINRYZE with rHuPH20 Dose Level 1 twice weekly (every 3 or 4 days) for 8 weeks.

Group Type EXPERIMENTAL

CINRYZE with rHuPH20

Intervention Type BIOLOGICAL

Interventions

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CINRYZE with rHuPH20

Intervention Type BIOLOGICAL

Other Intervention Names

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C1 esterase inhibitor (human) Recombinant human hyaluronidase

Eligibility Criteria

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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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shire

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Study Director

Role: STUDY_DIRECTOR

Takeda

Locations

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ViroPharma Investigational Site

Birmingham, Alabama, United States

Site Status

ViroPharma Investigational Site

Scottsdale, Arizona, United States

Site Status

ViroPharma Investigational Site

Bentonville, Arkansas, United States

Site Status

ViroPharma Investigational Site

Walnut Creek, California, United States

Site Status

ViroPharma Investigational Site

Colorado Springs, Colorado, United States

Site Status

ViroPharma Investigational Site

Tampa, Florida, United States

Site Status

ViroPharma Investigational Site

Boston, Massachusetts, United States

Site Status

ViroPharma Investigational Site

Las Vegas, Nevada, United States

Site Status

ViroPharma Investigational Site

Mineola, New York, United States

Site Status

ViroPharma Investigational Site

Cincinnati, Ohio, United States

Site Status

ViroPharma Investigational Site

Columbus, Ohio, United States

Site Status

ViroPharma Investigational Site

Lake Oswego, Oregon, United States

Site Status

ViroPharma Investigational Site

Hershey, Pennsylvania, United States

Site Status

ViroPharma Investigational Site

Pittsburgh, Pennsylvania, United States

Site Status

ViroPharma Investigational Site

Knoxville, Tennessee, United States

Site Status

ViroPharma Investigational Site

Dallas, Texas, United States

Site Status

ViroPharma Investigational Site

Spokane, Washington, United States

Site Status

ViroPharma Investigational Site

Berlin, , Germany

Site Status

ViroPharma Investigational Site

Essen, , Germany

Site Status

ViroPharma Investigational Site

Mainz, , Germany

Site Status

ViroPharma Investigational Site

München, , Germany

Site Status

ViroPharma Investigational Site

Barcelona, , Spain

Site Status

ViroPharma Investigational Site

Jönköping, , Sweden

Site Status

Countries

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United States Germany Spain Sweden

References

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Riedl MA, Lumry WR, Li HH, Banerji A, Bernstein JA, Ba M, Bjrkander J, Magerl M, Maurer M, Rockich K, Chen H, Schranz J. Subcutaneous administration of human C1 inhibitor with recombinant human hyaluronidase in patients with hereditary angioedema. Allergy Asthma Proc. 2016 Nov;37(6):489-500. doi: 10.2500/aap.2016.37.4006.

Reference Type RESULT
PMID: 27931305 (View on PubMed)

Beard N, Frese M, Smertina E, Mere P, Katelaris C, Mills K. Interventions for the long-term prevention of hereditary angioedema attacks. Cochrane Database Syst Rev. 2022 Nov 3;11(11):CD013403. doi: 10.1002/14651858.CD013403.pub2.

Reference Type DERIVED
PMID: 36326435 (View on PubMed)

Other Identifiers

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2012-000083-24

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

0624-206

Identifier Type: -

Identifier Source: org_study_id

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