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

Hereditary Angioedema Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01426763
• Other study ID #: 0624-204
• Secondary ID: SPD616-204
• Status: Completed
• Phase: Phase 2
• Start date: September 12, 2011
• Est. completion date: November 28, 2011

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 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: November 28, 2011
• Est. primary completion date: November 28, 2011
• 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. 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.

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema

Intervention

Biological:
• CINRYZE with rHuPH20

Locations

Country	Name	City	State
United States	ViroPharma Investigational Site	Atlanta	Georgia
United States	ViroPharma Investigational Site	Dallas	Texas
United States	ViroPharma Investigational Site	Scottsdale	Arizona
United States	ViroPharma Investigational Site	Walnut Creek	California

Sponsors (2)

Lead Sponsor	Collaborator
Shire	Halozyme Therapeutics

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 Participants With Local Injection Site Reactions, and Number of Participants Who Discontinue Study Drug or Withdraw From the Study		18 days
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
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
Secondary	Number of Subjects With C1 INH Antibodies		Day 1 (pre-dose), Day 18 (168 h post Dose 4), and 30 (±2) days after the last dose of study drug (Dose 4)