Clinical Trial: Berinert P Study of Subcutaneous Versus Intravenous Administration
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Pharmacokinetics Berinert P Study of Subcutaneous Versus Intravenous Administration in Subjects With Moderate Hereditary Angioedema - The Passion Study
Brief Summary:
The study is performed to investigate the subcutaneous (s.c.) versus intravenous (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.
The study is planned as a single centre, randomized, open-label, cross-over pharmacokinetic study.
Subjects will either start with s.c. or i.v. pasteurised C1-Inhibitor concentrate (Berinert P) and than switch to the treatment not administered before.
Detailed Summary: 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.
Sponsor: Johann Wolfgang Goethe University Hospital
Current Primary Outcome: Individual courses of C1-inhibitor levels, from these will be derived pharmacokinetic parameters [ Time Frame: i.v. and s.c.samples: 0, 0.25, 0.5, 0.75 hours and 1, 2, 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 120, 168, 336 an 504 hours. ]
Original Primary Outcome: Individual courses of C1-inhibitor levels, from these will be derived pharmacokinetic parameters [ Time Frame: i.v. and s.c.samples: 0, 0.25, 0.5, 0.75 hours and 1, 2, 4, 6, 8, 12, 16, 20, 24, 36, 48, 60, 72, 120 and 168 hours. ]
Current Secondary Outcome: Safety of s.c. and i.v. administration of study medication [ Time Frame: 2 years ]
Original Secondary Outcome: Safety of s.c. and i.v. administration of study medication. [ Time Frame: 2 years ]
Information By: Johann Wolfgang Goethe University Hospital
Dates:
Date Received: September 4, 2008
Date Started: September 2008
Date Completion:
Last Updated: January 18, 2011
Last Verified: January 2011
