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A Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous CINRYZE Administration

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ClinicalTrials.gov Identifier: NCT01095497
Recruitment Status : Completed
First Posted : March 30, 2010
Results First Posted : March 8, 2012
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Shire

Brief Summary:

The objectives of the study are to:

  1. Evaluate the safety and tolerability of CINRYZE administered by subcutaneous injection in subjects with hereditary angioedema
  2. Characterize the pharmacokinetics and pharmacodynamics of CINRYZE administered by subcutaneous injection
  3. Assess the immunogenicity of CINRYZE following subcutaneous administration

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 26 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Official Title: An Open-Label Multiple-Dose Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous (SC) Versus Intravenous (IV) Administration of CINRYZE in Adolescents and Adults With Hereditary Angioedema (HAE)
Study Start Date : May 2010
Actual Primary Completion Date : December 2010
Actual Study Completion Date : December 2010


Arm Intervention/treatment
Experimental: IV CINRYZE First, Then SC CINRYZE Dose 1 Biological: CINRYZE
C1 esterase inhibitor (human)

Experimental: IV CINRYZE First, Then SC CINRYZE Dose 2 Biological: CINRYZE
C1 esterase inhibitor (human)




Primary Outcome Measures :
  1. 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 in each treatment period ]

Secondary Outcome Measures :
  1. C1 Inhibitor (C1INH) and C4 Levels [ Time Frame: 18 days in each treatment period ]
  2. Number of Subjects With C1INH Antibodies [ Time Frame: 18 days in each treatment period ]


Information from the National Library of Medicine

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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. Have a confirmed diagnosis of HAE.
  2. During the 3 consecutive months prior to screening, have a history of less than 1 HAE attack per month (average) treated with C1INH therapy or any other blood products, ecallantide (Kalbitor), icatibant (Firazyr), antifibrinolytics (e.g., tranexamic acid), IV fluids, or narcotic analgesics.
  3. Agree to strictly adhere to the protocol-defined schedule of assessments and procedures.

Exclusion Criteria:

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

  1. Have received C1INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose.
  2. Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose.
  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.
  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.
  5. Have a history of abnormal blood clotting or other coagulopathy.
  6. Have a history of allergic reaction to CINRYZE or other blood products.
  7. Be pregnant or breastfeeding.
  8. Have received an immunization within 30 days prior to the first dose.
  9. Have participated in any other investigational drug study within 30 days prior to the first dose.

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): NCT01095497


Locations
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United States, Arizona
Allergy, Asthma and Immunology Associates
Scottsdale, Arizona, United States, 85251
United States, California
Allergy and Asthma Clinical Research, Inc.
Walnut Creek, California, United States, 94598
United States, Georgia
Family Allergy and Asthma Center
Atlanta, Georgia, United States, 30342
United States, Maryland
Institute for Asthma and Allergy
Chevy Chase, Maryland, United States, 20815
United States, Oregon
Allergy, Asthma and Dermatology Research Center
Lake Oswego, Oregon, United States, 97035
United States, Texas
AARA Research Center
Dallas, Texas, United States, 75231
United States, Washington
Marycliff Allergy Specialists
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Shire
Investigators
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Study Director: Jennifer Schranz, MD Shire

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Responsible Party: Shire
ClinicalTrials.gov Identifier: NCT01095497     History of Changes
Other Study ID Numbers: 0624-200
First Posted: March 30, 2010    Key Record Dates
Results First Posted: March 8, 2012
Last Update Posted: May 9, 2014
Last Verified: April 2014

Keywords provided by Shire:
HAE
C1 inhibitor (C1INH)
Subcutaneous

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
Genetic Diseases, Inborn
Complement C1 Inhibitor Protein
Complement Inactivating Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs