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`Berinert P study of Subcutaneous Versus Intravenous Administration (PASSION)
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`This study has been completed.
`Sponsor
`Johann Wolfgang Goethe University Hospitals
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`How to Read a Study Record
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`https:/Idinicdtridsgov/ct2/show/NCT00748202
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`CSL EXHIBIT 1023
`CSL v. Shire
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`Berinert P Study of Subcutaneous Versus Intravenous Administration - Full Text Vie...
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`Active Comparator: 2
`subcutaneous administration of C1-Inhibitor. After the end of the first observation period (at least after 7 days), each arm
`switches cross-over to the alternative administration mode not investigated so far.
`
`Drug: C1-Esterase
`Inhibitor
`1000 I.E.
`Other Name: Berinert
`P
`
`Detailed Description:
`Patients with hereditary angioedema (HAE), suffer from recurring and mostly unforeseeable attacks of acute oedema of subcutaneous tissues of various
`organs. The pathophysiological correlate of this disease is a deficiency in functionally active C1-Esterase Inhibitor (C1-INH). Today, two main types of HAE
`are described. In HAE type I, an impaired synthesis and an elevated turnover of a normal and functional active C1-INH molecule takes place, causing
`reduced amounts in functionally active C1-INH. In HAE type II, normal levels of a functionally impaired C1-INH molecule are synthesized. Both defects are
`inherited as an autosomal dominant trait. HAE type III is limited to females and not associated with C1-INH deficiency; the pathophysiology of this type
`remains to be determined. Corticosteroids, antihistamines or epinephrine usually do not exert any positive effect in acute attacks caused by HAE. This is of
`particular importance as these types of medication are often used in case of oedema in general. In case of acute oedema in patients suffering from HAE,
`the intravenous administration of C1-INH concentrate (e.g., Berinert P) is the treatment of choice. The study is performed to investigate the s.c. versus i.v.
`administration of Berinert P in patients with hereditary angioedema (HAE) to establish a second administration mode in cases where i.v. access is not
`suitable.
`
` Eligibility
`
`18 Years and older
`Ages Eligible for Study:
`Both
`Genders Eligible for Study:
`Accepts Healthy Volunteers: No
`
`Criteria
`Inclusion Criteria:
`• Subjects with an established diagnosis of HAE type I (C1-Inhibitor activity < 50% and C1-Inhibitor antigen < 15.4 mg/dl) or HAE type II (C1-Inhibitor
`activity < 50% and C1-Inhibitor antigen in normal or elevated concentration of dysfunctional protein).
`• Male and female subjects with an age of at least 18 years.
`• Subjects providing an informed consent.
`Exclusion Criteria:
`• Subjects without an established diagnosis of HAE.
`• Last C1-INH administration less than 7 days ago and/or acute attack.
`• Subjects with acquired angioedema (AAE).
`• All other types of angioedema not associated with C1-INH deficiency.
`• Treatment with any investigational drug (exclusive drugs appropriate for the treatment of acute angioedema) 30 days before study treatment.
`• Treatment with any other drug appropriate for the treatment of acute angioedema within 7 days before start of study treatment at each phase.
`• Danazol prophylaxis.
`• Prophylaxis with antifibrinolytics, EACA, tranexamic acid.
`• Subjects with a known hypersensitivity to study medication (Berinert P).
`• Pregnant women (pregnancy rapid assay required for women with childbearing potential), women currently breast-feeding, or with the intention to
`breast-feed
`• Subjects with malignant diseases.
`• Subjects with immunodeficiencies such as established acquired immunodeficiency syndrome.
`• Subjects with concurrent serious or acute illness or infection as per investigators judgement.
`• Subjects with mental conditions which render the subject or its legally acceptable representative unable to understand the nature, scope and possible
`consequences of the study.
`
` Contacts and Locations
`
`Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To
`learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn
`About Clinical Studies.
`
`Please refer to this study by its ClinicalTrials.gov identifier: NCT00748202
`
`Locations
`
`Germany
`Centre of Paediatrics III, Department of Haematology, Haemostaseology and Oncology, Comprehensive Care Centre for Thrombosis and Haemostasis, Johann-
`Frankfurt, Hessen, Germany, 60590
`
`Sponsors and Collaborators
`Johann Wolfgang Goethe University Hospitals
`Clinical trial center Rhine-Main
`ZKI Kindergerinnungslabor
`Institut für Medizinische Virologie JWG-University hospital
`CSL Behring
`PharmaPart
`University of Milan
`
`Investigators
`Principal Investigator: Wolfhart Kreuz, PD Phd Centre of Paediatrics III, Department of Haematology, Haemostaseology and Oncology, Comprehensive Care Cent
`
`https://clinicaltrials.gov/ct2/show/NCT00748202
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`19.02.2016
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` More Information
`
`No publications provided by Johann Wolfgang Goethe University Hospitals
`
`Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
`
`Martinez-Saguer I, Cicardi M, Suffritti C, Rusicke E, Aygören-Pürsün E, Stoll H, Rossmanith T, Feussner A, Kalina U, Kreuz W. Pharmacokinetics of
`plasma-derived C1-esterase inhibitor after subcutaneous versus intravenous administration in subjects with mild or moderate hereditary angioedema: the
`PASSION study. Transfusion. 2014 Jun;54(6):1552-61. doi: 10.1111/trf.12501. Epub 2013 Nov 24.
`
`Responsible Party:
`
`PD Dr. Wolfhart Kreuz, Centre of Paediatrics III, Department of Haematology, Haemostaseology and Oncology,
`Comprehensive Care Centre for Thrombosis and Haemostasis
`ClinicalTrials.gov Identifier: NCT00748202 History of Changes
`Other Study ID Numbers:
`CE1145_1001
`Study First Received:
`September 4, 2008
`Last Updated:
`January 18, 2011
`Health Authority:
`Germany: Paul-Ehrlich-Institut
`
`Keywords provided by Johann Wolfgang Goethe University Hospitals:
`Hereditary angioedema
`C1-Esterase inhibitor
`intravenous
`subcutaneous
`pharmacokinetic
`
`Additional relevant MeSH terms:
`Angioedema
`Angioedemas, Hereditary
`Cardiovascular Diseases
`Genetic Diseases, Inborn
`Hypersensitivity
`Hypersensitivity, Immediate
`Immune System Diseases
`Skin Diseases
`Skin Diseases, Vascular
`Urticaria
`
`ClinicalTrials.gov processed this record on February 17, 2016
`
`Vascular Diseases
`Complement C1 Inactivator Proteins
`Complement C1 Inhibitor Protein
`Complement C1s
`Complement Inactivating Agents
`Immunologic Factors
`Immunosuppressive Agents
`Pharmacologic Actions
`Physiological Effects of Drugs
`
`https://clinicaltrials.gov/ct2/show/NCT00748202
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`19.02.2016
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