Zal een beste man zijn, maar hier nieuwe rampspoed. Wat een toestand en drama.
"I.M.P.A.C.T. is a multi-center, prospective clinical trial conducted globally in more than 45 centers in 15 countries, enrolling 125 patients, and is the largest trial ever conducted in HAE. For the first time, a dose comparison study was conducted for a human C1-INH comparing 20U/ kg b.w. and 10U/ kg b.w. in a randomized, placebo-controlled, double-blind study design. The results will be submitted in the near future to the United States Food and Drug Administration, Health Canada and European Health Authorities in support of applications to license C1-INH concentrate for the treatment of acute attacks of HAE in the U.S., Canada, and Europe. CSL Behring has manufactured and provided C1-INH concentrate to HAE patients for over 20 years in Germany, Austria, Switzerland, and several other countries, where it is licensed under the trade name Berinert(R) P for the treatment of acute HAE attacks.
"The successful completion of this trial confirms longstanding observations made from the administration of more than 300,000 treatments of C1-INH concentrate in Europe. We are delighted that it will now be submitted for registration in the UK," said Dr. Hilary Longhurst, Consultant Immunologist, Barts and The London NHS Trust, London, England, and investigator of the I.M.P.A.C.T. trial."
Van draadje Camobs en met dank en vervolgdicussie dan ook op dit punt gaarne daar.
Groet, Jonas