Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks
This study is currently recruiting participants.
Verified March 2013 by ViroPharma
Sponsor:
ViroPharma
Collaborator:
Halozyme Therapeutics
Information provided by (Responsible Party):
ViroPharma
ClinicalTrials.gov Identifier:
NCT01756157
First received: June 29, 2012
Last updated: March 19, 2013
Last verified: March 2013
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hereditary Angioedema |
Biological: CINRYZE with rHuPH20 |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
hereditary angioedema
Drug Information available for:
Hyaluronidase
Hyaluronidase (Human recombinant)
SERPING1 protein, human
U.S. FDA Resources
Further study details as provided by ViroPharma:
Primary Outcome Measures:
- Number of angioedema attacks during each randomized therapy period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Cumulative Attack-Severity during each randomized therapy period [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]This score is the sum of the maximum symptom severity recorded for each angioedema attack in a treatment period.
| Estimated Enrollment: | 40 |
| Study Start Date: | December 2012 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | November 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Biological: CINRYZE with rHuPH20
Other Names:
|
|
Experimental: 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.
|
Biological: CINRYZE with rHuPH20
Other Names:
|
Eligibility| Ages Eligible for Study: | 12 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756157
Locations
| United States, Alabama | |
| ViroPharma Investigational Site | Recruiting |
| Birmingham, Alabama, United States, 35209 | |
| Contact: Clincal Operations Staff 866-331-5637 | |
| United States, California | |
| ViroPharma Investigational Site | Recruiting |
| Walnut Creek, California, United States, 94598 | |
| Contact: Clinical Operations Staff 866-331-5637 | |
| United States, Colorado | |
| ViroPharma Investigational Site | Recruiting |
| Colorado Springs, Colorado, United States, 80907 | |
| Contact: Clinical Operations Staff 866-331-5637 | |
| United States, Massachusetts | |
| ViroPharma Investigational Site | Recruiting |
| Boston, Massachusetts, United States, 02114 | |
| Contact: Clinical Operations Staff 866-331-5637 | |
| United States, Nevada | |
| ViroPharma Investigational Site | Recruiting |
| Las Vegas, Nevada, United States, 89106 | |
| Contact: Clinical Operations Staff 866-331-5637 | |
| United States, Ohio | |
| ViroPharma Investigational Site | Recruiting |
| Columbus, Ohio, United States, 43245 | |
| Contact: Clinical Operations Staff 866-331-5637 | |
| United States, Oregon | |
| ViroPharma Investigational Site | Recruiting |
| Lake Oswego, Oregon, United States, 97035 | |
| Contact: Clinical Operations Staff 866-331-5637 | |
| United States, Pennsylvania | |
| Clinical Operations Staff | Recruiting |
| Pittsburgh, Pennsylvania, United States, 15241 | |
| Contact: Clinical Operations Staff 866-331-5637 | |
| United States, Tennessee | |
| ViroPharma Investigational Site | Recruiting |
| Knoxville, Tennessee, United States, 37909 | |
| Contact: Clinical Operations Staff 866-331-5637 | |
| United States, Washington | |
| ViroPharma Investigational Site | Recruiting |
| Spokane, Washington, United States, 99204 | |
| Contact: Clinical Operations Staff 866-331-5637 | |
| Germany | |
| ViroPharma Investigational Site | Recruiting |
| Berlin, Germany | |
| Contact: Clinical Operations Staff +32 2 747 09 71 | |
| ViroPharma Investigational Site | Recruiting |
| Essen, Germany | |
| Contact: Clinical Operations Staff +32 2 747 09 71 | |
| ViroPharma Investigational Site | Recruiting |
| Mainz, Germany | |
| Contact: Clinical Operations Staff +32 2 747 09 71 | |
| ViroPharma Investigational Site | Recruiting |
| Munchen, Germany | |
| Contact: Clinical Operations Staff +32 2 747 09 71 | |
| Spain | |
| ViroPharma Investigational Site | Recruiting |
| Barcelona, Spain | |
| Contact: Clinical Operations Staff +32 2 747 09 71 | |
| Sweden | |
| ViroPharma Investigational Site | Recruiting |
| Jonkoping, Sweden | |
| Contact: Clinical Operations Staff +32 2 747 09 71 | |
Sponsors and Collaborators
ViroPharma
Halozyme Therapeutics
Investigators
| Study Director: | Jennifer Schranz, MD | ViroPharma |
More Information
No publications provided
| Responsible Party: | ViroPharma |
| ClinicalTrials.gov Identifier: | NCT01756157 History of Changes |
| Other Study ID Numbers: | 0624-206, 2012-000083-24 |
| Study First Received: | June 29, 2012 |
| Last Updated: | March 19, 2013 |
| Health Authority: | United States: Food and Drug Administration Germany: Paul-Ehrlich-Institut Hungary: National Institute of Pharmacy Spain: Agencia Española de Medicamentos y Productos Sanitarios France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Romania: National Agency for Medicines and Medical Devices Sweden: Medical Products Agency |
Keywords provided by ViroPharma:
|
Crossover Prevention Hereditary Angioedema C1 esterase inhibitor |
C1 inhibitor Subcutaneous Recombinant human hyaluronidase |
Additional relevant MeSH terms:
|
Angioedema Angioedemas, Hereditary Vascular Diseases Cardiovascular Diseases Urticaria Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |
Genetic Diseases, Inborn Complement C1 Inactivator Proteins Complement C1 Inhibitor Protein Complement C1 Complement C1s Complement Inactivating Agents Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013