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

Phase 2

Completed

• Conditions: Hereditary Angioedema
• Interventions: Biological: CINRYZE

• Registration Number: NCT01095497
• Lead Sponsor: 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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-02-22
• Study First Submitted QC: 2010-03-26
• Study First Posted: 2010-03-30
• Study Start: 2010-06-07
• Primary Completion: 2010-12-16
• Study Completion: 2010-12-16
• Results First Submitted: 2011-12-23
• Results First Submitted QC: 2012-02-07
• Results First Posted: 2012-03-08
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-14
• Last Update Posted: 2021-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
IV CINRYZE First, Then SC CINRYZE Dose 2	CINRYZE	-
IV CINRYZE First, Then SC CINRYZE Dose 1	CINRYZE	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Mean Change C1 Inhibitor (C1INH)	18 days in each treatment period	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.
Mean Change C4 Compliment	18 days in each treatment period	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.
Number of Participants With C1 Inhibitor (INH) Antibodies	18 days in each treatment period

Trial Locations

Locations (7)

Allergy, Asthma and Immunology Associates; 🇺🇸 Scottsdale, Arizona, United States

Allergy and Asthma Clinical Research, Inc.; 🇺🇸 Walnut Creek, California, 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

Marycliff Allergy Specialists; 🇺🇸 Spokane, Washington, United States

Allergy, Asthma and Dermatology Research Center; 🇺🇸 Lake Oswego, Oregon, United States