A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor

Hereditary Angioedema Types I and II Clinical Trial

Official title:

A Randomized, Double-blind, Single-center, Cross-over Study to Evaluate the Safety, Bioavailability and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor Administered Intravenously

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01760343
• Other study ID #: CSL830_1001
• Secondary ID: 2012-002429-31
• Status: Completed
• Phase: Phase 1
• First received: December 24, 2012
• Last updated: April 4, 2013
• Start date: January 2013
• Est. completion date: March 2013

Study information

• Verified date: April 2013
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationGermany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

A new formulation of Berinert (CSL830) is being investigated for the management of hereditary angioedema (HAE). The main aim of the study is to assess the safety of a single 1500 IU dose of the new formulation of Berinert. This study will also look at the pharmacokinetics of CSL830 relative to Berinert currently on the market.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 45 Years

Eligibility

Inclusion Criteria:

• Healthy subjects without clinically significant medical conditions or laboratory abnormalities

• Male or female subjects aged 18 to 45 years inclusive, at the time of informed consent

• Non-smokers

• Body mass index of 18.0 to 29.0 kg/m2 inclusive

Exclusion Criteria:

• Previous history of clinically significant arterial or venous thrombosis, current history of a clinically significant pro-thrombotic risk, or a clinically significant abnormality on laboratory thrombotic screen at the screening visit.

• Known or suspected hypersensitivity to the investigational medicinal product (IMP), or to any excipients of the IMP.

• Female subjects who started taking or changed dose of any hormonal contraceptive regimen or hormone replacement therapy (ie, estrogen/progesterone containing products) within 3 months before the screening visit.

• Alcohol, drug, or medication abuse within one year before the study.

• Female subjects of childbearing potential (eg, not post-menopausal) either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or have a vasectomized partner, or not sexually abstinent for the entire duration of the study, or not surgically sterile.

• Participation in another clinical study (or use of another IMP) within 30 days (or 5 times the half-life, whichever is longer) before, or during, the study.

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Angioedema
• Hereditary Angioedema Types I and II

Intervention

Biological:
• Berinert
Berinert is a plasma-derived C1 esterase inhibitor (human), supplied as a freeze-dried powder for reconstitution.
• CSL830
CSL830 is a formulation of Berinert.

Locations

Country	Name	City	State
Germany	Study Site	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events (AEs) within 24 hours of CSL830 infusion		From the start of infusion to 24 hours after the end of infusion	Yes
Secondary	Incidence of adverse events (AEs) within 10 days of the CSL830 infusion		From the start of infusion to 10 days after the infusion	Yes
Secondary	Relative bioavailability of CSL830 versus Berinert - Cmax	Relative bioavailability in terms of maximum concentration (Cmax) of CSL830 versus Berinert	240 hours	No
Secondary	Relative bioavailability of CSL830 versus Berinert - AUC	Relative bioavailability in terms of area under the curve from timepoint 0 to infinity (AUC0-8) of CSL830 versus Berinert	240 hours	No