A Study to Evaluate the Safety and Pharmacology of Subcutaneous Administration of CINRYZE With Recombinant Human Hyaluronidase

This study has been completed.
Sponsor:
Collaborator:
Halozyme Therapeutics
Information provided by (Responsible Party):
Shire
ClinicalTrials.gov Identifier:
NCT01426763
First received: August 25, 2011
Last updated: March 19, 2014
Last verified: March 2014
  Purpose

The objectives of the study are to:

  1. Evaluate the safety and tolerability of subcutaneously administered CINRYZE with recombinant human hyaluronidase (rHuPH20) in subjects with hereditary angioedema (HAE) who previously participated in CINRYZE Study 0624-200 (NCT01095497)
  2. Characterize the pharmacokinetics and pharmacodynamics of subcutaneously administered CINRYZE with rHuPH20
  3. Assess the immunogenicity of CINRYZE following subcutaneous (SC) administration of CINRYZE with rHuPH20

Condition Intervention Phase
Hereditary Angioedema
Biological: CINRYZE with rHuPH20
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: An Open-label Multiple-dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administration of CINRYZE® (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase (rHuPH20) in Subjects With Hereditary Angioedema

Resource links provided by NLM:


Further study details as provided by Shire:

Primary Outcome Measures:
  • Incidence and Severity of Adverse Events, Number of Subjects With Local Injection Site Reactions, and Number of Subjects Who Discontinue Study Drug or Withdraw From the Study [ Time Frame: 18 days ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • C1 Inhibitor (C1 INH) and C4 Levels [ Time Frame: 18 days ] [ Designated as safety issue: No ]
  • Number of Subjects With C1 INH Antibodies [ Time Frame: Through 30 days after final dose ] [ Designated as safety issue: Yes ]

Enrollment: 12
Study Start Date: September 2011
Study Completion Date: November 2011
Primary Completion Date: November 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SC CINRYZE with rHuPH20 Dose Level 1
Subcutaneous injection of 1000 Units of CINRYZE with 20,000 Units of rHuPH20 twice weekly for two weeks
Biological: CINRYZE with rHuPH20
Other Names:
  • C1 esterase inhibitor (human)
  • Recombinant human hyaluronidase
Experimental: SC CINRYZE with rHuPH20 Dose Level 2
Subcutaneous injection of 2000 Units of CINRYZE with 40,000 Units of rHuPH20 twice weekly for two 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:

To be eligible for this protocol, a subject must:

  1. Provide informed consent/assent, as appropriate.
  2. Have previously participated in CINRYZE Study 0624-200 and completed the subcutaneous therapy period in that study.
  3. During the 3 consecutive months prior to screening, have a history of less than 1 HAE attack per month (average) that required treatment with C1 INH therapy or other blood products.
  4. Agree to avoid his/her known HAE triggers during the study to the best of his/her ability.

Exclusion Criteria:

To be eligible for this protocol, a subject must not:

  1. Have received C1 INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose of study drug.
  2. Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose of study drug.
  3. Have any change (start, stop, or change in dose) in androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 14 days prior to the first dose of study drug.
  4. 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.
  5. Have a history of abnormal blood clotting.
  6. Have a history of allergic reaction to products containing C1 INH or other blood products.
  7. Have a known allergy to hyaluronidase or any other ingredient in rHuPH20.
  8. Be pregnant or breastfeeding.
  9. Have received an investigational study drug within 30 days prior to the first dose of study drug.
  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: NCT01426763

Locations
United States, Arizona
ViroPharma Investigational Site
Scottsdale, Arizona, United States, 85251
United States, California
ViroPharma Investigational Site
Walnut Creek, California, United States, 94598
United States, Georgia
ViroPharma Investigational Site
Atlanta, Georgia, United States, 30342
United States, Texas
ViroPharma Investigational Site
Dallas, Texas, United States, 75231
Sponsors and Collaborators
Shire
Halozyme Therapeutics
Investigators
Study Director: Jennifer Schranz, MD, FRCP(C) ViroPharma
  More Information

No publications provided

Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01426763     History of Changes
Other Study ID Numbers: 0624-204
Study First Received: August 25, 2011
Results First Received: November 30, 2012
Last Updated: March 19, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Shire:
HAE
C1 esterase inhibitor
C1 INH
Subcutaneous
hyaluronidase
rHuPH20

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 October 23, 2014