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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01426763
Recruitment Status : Completed
First Posted : August 31, 2011
Results First Posted : January 4, 2013
Last Update Posted : July 19, 2021
Sponsor:
Collaborator:
Halozyme Therapeutics
Information provided by (Responsible Party):
Takeda ( Shire )

Study Description
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Brief Summary:

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 or disease Intervention/treatment Phase
Hereditary Angioedema Biological: CINRYZE with rHuPH20 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
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
Actual Study Start Date : September 12, 2011
Actual Primary Completion Date : November 28, 2011
Actual Study Completion Date : November 28, 2011

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence and Severity of Adverse Events, Number of Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study [ Time Frame: 18 days ]

Secondary Outcome Measures :
  1. Mean Change C1 Inhibitor (C1INH) [ Time Frame: 18 days ]
    Mean Change in Baseline in Observed Plasma Concentration of C1 Inhibitor (C1INH) Antigen. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.

  2. Mean Change C4 Compliment [ Time Frame: 18 days ]
    Mean Change in Baseline in Observed Plasma Concentration of C4 Compliment. Baseline-corrected concentrations were derived by subtracting the observed pre-dose concentrations on Day 1 of each treatment period from each observed concentration.

  3. Number of Subjects With C1 INH Antibodies [ Time Frame: Day 1 (pre-dose), Day 18 (168 h post Dose 4), and 30 (±2) days after the last dose of study drug (Dose 4) ]

Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01426763


Locations
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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
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Study Director: Study Director Takeda
More Information
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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01426763    
Other Study ID Numbers: 0624-204
SPD616-204 ( Other Identifier: Sponsor )
First Posted: August 31, 2011    Key Record Dates
Results First Posted: January 4, 2013
Last Update Posted: July 19, 2021
Last Verified: June 2021
Keywords provided by Takeda ( Shire ):
HAE
C1 esterase inhibitor
C1 INH
 Subcutaneous
hyaluronidase
rHuPH20
Additional relevant MeSH terms:
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Angioedema
Angioedemas, Hereditary
Vascular Diseases
Cardiovascular Diseases
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Hereditary Complement Deficiency Diseases
 Primary Immunodeficiency Diseases
Genetic Diseases, Inborn
Immunologic Deficiency Syndromes
Complement C1s
Complement C1 Inhibitor Protein
Complement C1 Inactivator Proteins
Immunologic Factors
Physiological Effects of Drugs
Complement Inactivating Agents
Immunosuppressive Agents