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

NCT01095497 | Completed Phase 2 Results

• 2 other identifiers: 0624-200SPD616-200
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 7

Brief Summary

The objectives of the study are to:

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

Conditions

Hereditary Angioedema

Keywords

HAE; C1 inhibitor (C1INH); Subcutaneous

Outcome Measures

Primary Outcomes (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.

  18 days in each treatment period

Secondary Outcomes (3)

• Mean Change C1 Inhibitor (C1INH)

  18 days in each treatment period

• Mean Change C4 Compliment

  18 days in each treatment period

• Number of Participants With C1 Inhibitor (INH) Antibodies

  18 days in each treatment period

Study Arms (2)

IV CINRYZE First, Then SC CINRYZE Dose 1

EXPERIMENTAL

Biological: CINRYZE

IV CINRYZE First, Then SC CINRYZE Dose 2

EXPERIMENTAL

Biological: CINRYZE

Interventions

CINRYZE BIOLOGICAL

C1 esterase inhibitor (human)

IV CINRYZE First, Then SC CINRYZE Dose 1; IV CINRYZE First, Then SC CINRYZE Dose 2

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for this protocol, a subject must:
• Have a confirmed diagnosis of HAE.
• 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.
• Agree to strictly adhere to the protocol-defined schedule of assessments and procedures.

You may not qualify if:

• To be eligible for this protocol, a subject must not:
• Have received C1INH therapy or any blood products for treatment or prevention of an HAE attack within 14 days prior to the first dose.
• Have received any ecallantide (Kalbitor), icatibant (Firazyr), or antifibrinolytics (e.g., tranexamic acid) within 14 days prior to the first dose.
• 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.
• 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.
• Have a history of abnormal blood clotting or other coagulopathy.
• Have a history of allergic reaction to CINRYZE or other blood products.
• Be pregnant or breastfeeding.
• Have received an immunization within 30 days prior to the first dose.
• Have participated in any other investigational drug study within 30 days prior to the first dose.

Sponsors & Collaborators

• Shire: lead

Study Sites (7)

Allergy, Asthma and Immunology Associates

Scottsdale, Arizona, 85251, United States

Location

Allergy and Asthma Clinical Research, Inc.

Walnut Creek, California, 94598, United States

Location

Family Allergy and Asthma Center

Atlanta, Georgia, 30342, United States

Location

Institute for Asthma and Allergy

Chevy Chase, Maryland, 20815, United States

Location

Allergy, Asthma and Dermatology Research Center

Lake Oswego, Oregon, 97035, United States

Location

AARA Research Center

Dallas, Texas, 75231, United States

Location

Marycliff Allergy Specialists

Spokane, Washington, 99204, United States

Location

MeSH Terms

Conditions

Angioedemas, Hereditary

Interventions

SERPING1 protein, human

Condition Hierarchy (Ancestors)

Angioedema; Vascular Diseases; Cardiovascular Diseases; Hereditary Complement Deficiency Diseases; Primary Immunodeficiency Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Urticaria; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Immunologic Deficiency Syndromes

Results Point of Contact

• Title: Study Director
• Organization: Shire

ClinicalTransparency@shire.com

+1 866 842 5335

Study Officials

• Study Director

  Takeda

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 22, 2010
• First Posted: March 30, 2010
• Study Start: June 7, 2010
• Primary Completion: December 16, 2010
• Study Completion: December 16, 2010
• Last Updated: July 9, 2021
• Results First Posted: March 8, 2012

Record last verified: 2021-06

Locations

US (7)