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

Hereditary Angioedema Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01095497
• Other study ID #: 0624-200
• Secondary ID: SPD616-200
• Status: Completed
• Phase: Phase 2
• Start date: June 7, 2010
• Est. completion date: December 16, 2010

Study information

• Verified date: June 2021
• Source: Takeda
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 16, 2010
• Est. primary completion date: December 16, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

Biological:
• CINRYZE
C1 esterase inhibitor (human)

Locations

Country	Name	City	State
United States	Family Allergy and Asthma Center	Atlanta	Georgia
United States	Institute for Asthma and Allergy	Chevy Chase	Maryland
United States	AARA Research Center	Dallas	Texas
United States	Allergy, Asthma and Dermatology Research Center	Lake Oswego	Oregon
United States	Allergy, Asthma and Immunology Associates	Scottsdale	Arizona
United States	Marycliff Allergy Specialists	Spokane	Washington
United States	Allergy and Asthma Clinical Research, Inc.	Walnut Creek	California

Sponsors (1)

Lead Sponsor	Collaborator
Shire

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		18 days in each treatment period
Secondary	Mean Change C1 Inhibitor (C1INH)	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.	18 days in each treatment period
Secondary	Mean Change C4 Compliment	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.	18 days in each treatment period
Secondary	Number of Participants With C1 Inhibitor (INH) Antibodies		18 days in each treatment period