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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01576523
Other study ID # CSL830_2001
Secondary ID 2011-005013-36
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date April 2012
Est. completion date December 2012

Study information

Verified date January 2021
Source CSL Behring
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to assess what happens to C1-esterase inhibitor that is administered under the skin of subjects with hereditary angioedema. Three different dosing regimens of C1-esterase inhibitor will be assessed. Each subject will be assigned to receive 2 of the 3 dosing regimens, each for 4 weeks. The activity and concentration of C1-esterase inhibitor in the blood will be measured during each 4-week period. The study will also examine how well C1-esterase inhibitor administered under the skin is tolerated by the subjects.


Recruitment information / eligibility

Status Completed
Enrollment 18
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Males or females aged 18 years or older. - Laboratory-confirmed hereditary angioedema type I or II. - Less than two hereditary angioedema attacks per month in the last three months. - Body weight of 50.0 kg to 110.0 kg. Exclusion Criteria: - Receiving prophylactic C1-esterase inhibitor therapy. - Received C1-esterase inhibitor, ecallantide, icatibant or any blood products for the prevention or treatment of hereditary angioedema within 7 days before the screening visit. - Intends to use recombinant C1-esterase inhibitor or fresh frozen plasma for the acute treatment of hereditary angioedema during the study. - Received androgen therapy (e.g., danazol, oxandrolone, stanozolol, testosterone) within 30 days before the screening visit. - Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (i.e., estrogen/progesterone-containing products) within 3 months prior to the screening visit. - Known or suspected hypersensitivity to the study product, or to any excipients of the study product. - Pregnancy or lactation.

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
C1-esterase inhibitor - single intravenous dose
A single intravenous dose of C1-esterase inhibitor (Berinert) at 20 units per kg body weight will be administered to all subjects prior to receiving the first dose of subcutaneous C1-esterase inhibitor.
C1-esterase inhibitor - subcutaneous low dose
A low dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
C1-esterase inhibitor - subcutaneous medium dose
A medium dose of C1-esterase inhibitor will be administered subcutaneously twice a week for four weeks.
C1-esterase inhibitor - subcutaneous high dose
A high dose of C1-esterase inhibitor will administered subcutaneously twice a week for four weeks.

Locations

Country Name City State
Germany Study Site Berlin
Germany Study Site Frankfurt
Germany Study Site Mainz
United States Study Site Atlanta Georgia
United States Study Site Chevy Chase Maryland
United States Study Site Cincinnati Ohio
United States Study Site Hershey Pennsylvania
United States Study Site Toledo Ohio

Sponsors (2)

Lead Sponsor Collaborator
CSL Behring Parexel

Countries where clinical trial is conducted

United States,  Germany, 

References & Publications (1)

Zuraw BL, Cicardi M, Longhurst HJ, Bernstein JA, Li HH, Magerl M, Martinez-Saguer I, Rehman SM, Staubach P, Feuersenger H, Parasrampuria R, Sidhu J, Edelman J, Craig T. Phase II study results of a replacement therapy for hereditary angioedema with subcuta — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Modeled C1-esterase Inhibitor Functional Activity Trough Level Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens, based on modeling and simulation at the fourth week of each dosing regimen
Secondary As-observed C1-esterase Inhibitor Functional Activity Trough Level Mean trough C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens during the last week of 4-week dose regimen
Secondary C1-esterase Inhibitor Concentration Trough Level Mean trough C1-esterase inhibitor concentration of the low, medium and high subcutaneous dose regimens during the last week of 4-week dose regimen
Secondary C4 Concentration Trough Level Mean trough C4 concentration of the low, medium and high subcutaneous dose regimens during the last week of 4-week dose regimen
Secondary Change From Baseline in C1-esterase Inhibitor Functional Activity Mean change from baseline of C1-esterase inhibitor functional activity of the low, medium and high subcutaneous dose regimens Baseline and during the last week of 4-week dose regimen
Secondary Change From Baseline in C1-esterase Inhibitor Concentration Mean change from baseline of C1-esterase inhibitor concentration of the low, medium and high subcutaneous dose regimens Baseline and during the last week of 4-week dose regimen
Secondary Change From Baseline in C4 Concentration Mean change from baseline of C4 concentration of the low, medium and high subcutaneous dose regimens Baseline and during the last week of 4-week dose regimen
See also
  Status Clinical Trial Phase
Completed NCT01467947 - Postmarketing Immunogenicity Study in HAE Subjects Treated With Berinert Phase 4
Completed NCT01912456 - A Study to Evaluate the Clinical Efficacy and Safety of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema Phase 3
Completed NCT01760343 - A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor Phase 1
Completed NCT04618211 - Dose-ranging Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema Phase 2
Recruiting NCT06343779 - Study of Oral Deucrictibant Soft Capsule for On-Demand Treatment of Angioedema Attacks in Adolescents and Adults With Hereditary Angioedema Phase 3
Completed NCT02316353 - A Study to Evaluate the Long-term Clinical Safety and Efficacy of Subcutaneously Administered C1-esterase Inhibitor in the Prevention of Hereditary Angioedema Phase 3
Recruiting NCT05396105 - Extension Study of Oral PHA-022121 for Acute Treatment of Angioedema Attacks in Patients With Hereditary Angioedema Phase 2/Phase 3
Withdrawn NCT01832896 - Study to Assess the Tolerability and Safety of Ecallantide in Children and Adolescents With Hereditary Angioedema Phase 2
Active, not recruiting NCT05047185 - Dose-ranging Study of Oral PHA-022121 for Prophylaxis Against Angioedema Attacks in Patients With Hereditary Angioedema Type I or Type II Phase 2