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Subcutaneous CINRYZE With Recombinant Human Hyaluronidase for Prevention of Angioedema Attacks

This study has been completed.
Sponsor:
Collaborator:
Halozyme Therapeutics
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01756157
First received: June 29, 2012
Last updated: June 17, 2014
Last verified: June 2014
  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:


Further study details as provided by Shire:

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.


Enrollment: 47
Study Start Date: December 2012
Study Completion Date: September 2013
Primary Completion Date: August 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:
  • C1 esterase inhibitor (human)
  • Recombinant human hyaluronidase
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:
  • C1 esterase inhibitor (human)
  • Recombinant human hyaluronidase

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01756157

  Show 23 Study Locations
Sponsors and Collaborators
Shire
Halozyme Therapeutics
Investigators
Study Director: Jennifer Schranz, MD ViroPharma
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01756157     History of Changes
Other Study ID Numbers: 0624-206, 2012-000083-24
Study First Received: June 29, 2012
Last Updated: June 17, 2014
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 Shire:
Crossover
Prevention
Hereditary Angioedema
C1 esterase inhibitor
C1 inhibitor
Subcutaneous
Recombinant human hyaluronidase

Additional relevant MeSH terms:
Angioedema
Angioedemas, Hereditary
Cardiovascular Diseases
Genetic Diseases, Inborn
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Skin Diseases
Skin Diseases, Vascular
Urticaria
Vascular Diseases
Complement C1 Inactivator Proteins
Complement C1 Inhibitor Protein
Complement C1s
Complement Inactivating Agents
Immunologic Factors
Immunosuppressive Agents
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 20, 2014