A Study to Evaluate the Safety and Pharmacokinetics of Two Formulations of C1-esterase Inhibitor
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ClinicalTrials.gov Identifier: NCT01760343 |
Recruitment Status :
Completed
First Posted : January 4, 2013
Last Update Posted : April 5, 2013
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Condition or disease | Intervention/treatment | Phase |
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Hereditary Angioedema Types I and II | Biological: Berinert Biological: CSL830 | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 16 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
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 |
Study Start Date : | January 2013 |
Actual Primary Completion Date : | March 2013 |
Actual Study Completion Date : | March 2013 |

Arm | Intervention/treatment |
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Experimental: Berinert, then CSL830
A single intravenous dose of Berinert at 1500 units (1500 IU), followed by a single intravenous dose of CSL830 at 1500 IU.
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Biological: Berinert
Berinert is a plasma-derived C1 esterase inhibitor (human), supplied as a freeze-dried powder for reconstitution. Biological: CSL830 CSL830 is a formulation of Berinert. |
Experimental: CSL830, then Berinert
A single intravenous dose of CSL830 at 1500 IU, followed by a single intravenous dose of Berinert at 1500 IU.
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Biological: Berinert
Berinert is a plasma-derived C1 esterase inhibitor (human), supplied as a freeze-dried powder for reconstitution. Biological: CSL830 CSL830 is a formulation of Berinert. |
- Incidence of adverse events (AEs) within 24 hours of CSL830 infusion [ Time Frame: From the start of infusion to 24 hours after the end of infusion ]
- Incidence of adverse events (AEs) within 10 days of the CSL830 infusion [ Time Frame: From the start of infusion to 10 days after the infusion ]
- Relative bioavailability of CSL830 versus Berinert - Cmax [ Time Frame: 240 hours ]Relative bioavailability in terms of maximum concentration (Cmax) of CSL830 versus Berinert
- Relative bioavailability of CSL830 versus Berinert - AUC [ Time Frame: 240 hours ]Relative bioavailability in terms of area under the curve from timepoint 0 to infinity (AUC0-∞) of CSL830 versus Berinert

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Ages Eligible for Study: | 18 Years to 45 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01760343
Germany | |
Study Site | |
Berlin, Germany |
Study Director: | Global Clinical Program Director | CSL Behring |
Responsible Party: | CSL Behring |
ClinicalTrials.gov Identifier: | NCT01760343 |
Other Study ID Numbers: |
CSL830_1001 2012-002429-31 ( EudraCT Number ) |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | April 5, 2013 |
Last Verified: | April 2013 |
Angioedema Angioedemas, Hereditary Hereditary Angioedema Types I and II Vascular Diseases Cardiovascular Diseases Urticaria |
Skin Diseases, Vascular Skin Diseases Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Genetic Diseases, Inborn |