check_circleStudy Completed
Blood Coagulation Disorders, Hemophilia A
Bayer Identifier:
12954
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial to Evaluate the Efficacy and Safety of a new full length recombinant human FVIII for Hemophilia A
Trial purpose
The study will assess the pharmacokinetics (part A) safety, tolerability, and efficacy of prophylaxis treatment (2 to 3 times a week) (part B) with BAY81-8973 over a one year period (split into two six month treatment periods). The study will compare 2 different methods (assays) for measuring the amount of study drug, the chromogenic substrate assay per European Pharmacopeia (CS/EP) with the classical assay (Chromogenic Substrate Adjusted, CS/ADJ). During one six month period patients will receive the study drug where the dose has been measured using the” (CS/EP) and during the other six months period the dose will be measured based on the Chromogenic Substrate Adjusted assay CS/ADJ)
Key Participants Requirements
Sex
MaleAge
12 - 65 YearsTrial summary
Enrollment Goal
74Trial Dates
December 2009 - March 2013Phase
Phase 3Could I Receive a placebo
NoProducts
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Terminated | Oxford, OX3 7LJ, United Kingdom | |
Completed | Sheffield, S10 2JF, United Kingdom | |
Completed | Sacramento, 95817, United States | |
Completed | Krakow, 31-501, Poland | |
Completed | A Coruña, 15006, Spain | |
Completed | Valencia, 46026, Spain | |
Terminated | Göteborg, 413 45, Sweden | |
Terminated | Malmö, 205 02, Sweden | |
Terminated | Karolinska Universitetssjukhuset i Solna | Stockholm, 171 76, Sweden |
Completed | Parktown, 2132, South Africa | |
Terminated | Wien, 1090, Austria | |
Terminated | Jakarta, 10430, Indonesia | |
Terminated | Bangalore, 34, India | |
Terminated | Pune, 411005, India | |
Completed | Tampa, 33607, United States | |
Completed | Boston, 02115, United States | |
Completed | Cleveland, 44106-2602, United States | |
Terminated | Orange, 92868, United States | |
Completed | Warszawa, 02-776, Poland | |
Completed | Barcelona, 08035, Spain | |
Terminated | Santander, 39008, Spain | |
Terminated | Jaén, 23007, Spain | |
Completed | DK-Aarhus N, 8200, Denmark | |
Terminated | Oslo, 0027, Norway | |
Completed | Pretoria, 0001, South Africa | |
Completed | Ramat Gan, 5262000, Israel | |
Terminated | Jakarta, 10430, Indonesia | |
Terminated | Mumbai, 400012, India | |
Terminated | Changhua, 500, Taiwan | |
Completed | Hongkong, Hong Kong | |
Terminated | Bangkok, 10400, Thailand | |
Terminated | Karachi, 75300, Pakistan | |
Terminated | Taipei, 11217, Taiwan | |
Terminated | Taipei, 10016, Taiwan | |
Terminated | Bangkok, 10330, Thailand | |
Completed | Bonn, 53127, Germany | |
Terminated | Mainz, 55131, Germany | |
Terminated | Frankfurt, 60596, Germany | |
Terminated | Magdeburg, 39112, Germany | |
Terminated | Dundee, DD1 9SY, United Kingdom | |
Terminated | East Lansing, 48823, United States | |
Completed | Kansas City, 64108-9898, United States | |
Completed | Milano, 20122, Italy | |
Completed | Catanzaro, 88100, Italy | |
Completed | Vicenza, 36100, Italy | |
Completed | Napoli, 80131, Italy | |
Terminated | Napoli, 80144, Italy | |
Terminated | Roma, 00168, Italy | |
Completed | Oviedo, 33006, Spain | |
Terminated | Bahia Blanca, B8001HXM, Argentina | |
Terminated | Rosario, S2000CKF, Argentina | |
Terminated | Graz, 8036, Austria | |
Completed | Izmir, 35-100, Turkey | |
Completed | Adana, 01330, Turkey | |
Completed | Antalya, 07059, Turkey | |
Terminated | Zagreb, 10000, Croatia | |
Terminated | Nis, 18000, Serbia | |
Terminated | Belgrade, 11000, Serbia | |
Terminated | Novi Sad, 21000, Serbia | |
Terminated | Beograd, 11000, Serbia | |
Terminated | London, SE1 7EH, United Kingdom | |
Terminated | Homburg, 66421, Germany |
Primary Outcome
- Part A - Area under the drug concentration-time curve (AUC)To examine the Pharmacokinetic (PK) characteristics of BAY 81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay.date_rangeTime Frame:Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection. AUC calculated from time of injection to infinity.enhanced_encryptionNoSafety Issue:
- Part A - Half-life (t 1/2)To examine the PK characteristics of BAY81-8973 and ensure that the new drug is similar to Kogenate FS. All results are based on the chromogenic assay.date_rangeTime Frame:Samples taken at pre-injection, and at 0.25, 0.5, 1, 3, 6, 8, 24, 30 and 48 hours post injection.enhanced_encryptionNoSafety Issue:
- Part B - Annualized number of total bleedsThe annualized number of bleeds experienced by participantsdate_rangeTime Frame:12 months after randomizationenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Part B - The in vivo recovery values of Human factor VIII (FVIII)The amount of Factor VIII found in blood samples taken after the injection of the study drug at the beginning of the CS/EP treatment period.date_rangeTime Frame:15-30 minutes after the injectionenhanced_encryptionNoSafety Issue:
- Part B - Annualized number of bleeds in each 6-month potency assignment periodThe annualized number of bleeds experienced by participants in each of the two treatment periodsdate_rangeTime Frame:6 months on each potencyenhanced_encryptionNoSafety Issue:
- Part B - Control of bleeding as measured by the number of injections required to treat a bleedThe number of injections needed by participants to stop a bleeddate_rangeTime Frame:6 months on each potencyenhanced_encryptionNoSafety Issue:
- Part B - changes from baseline at 12 months in quality of life (QoL) as measured by Transformed Total Score of Haemo-QoL questionnaireA measure of how treatment with BAY81-8973 affected the daily life of participants. the scoring system has 100 points. 0 is the worst possible score. 100 is the best possible score. Positive changes from baseline indicate an improvement in quality of life and negative changes indicate a deterioration.date_rangeTime Frame:Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- Part B - Changes from baseline at 12 months in Utility Index as measured by EQ–5D questionaireA measure of how treatment with BAY81-8973 affected the daily life of participants. 1.0 = Best possible score, -0.594 = Worst possible score. Positive changes from baseline indicate an improvement and negative changes indicate a deterioration.date_rangeTime Frame:Baseline and 12 monthsenhanced_encryptionNoSafety Issue:
- Part A - Number of participants with inhibitory antibody formationA test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973date_rangeTime Frame:Up to 6 weeks after first injection of study drugenhanced_encryptionYesSafety Issue:
- Part B - Number of participants with incidence of inhibitory antibody formationA test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973date_rangeTime Frame:Up to 12 months after drug administrationenhanced_encryptionYesSafety Issue:
- Part C - Number of participants with incidence of inhibitory antibody formationA test to ensure that participants have not developed antibodies that will interfere with the action of BAY81-8973date_rangeTime Frame:before and 3 weeks after surgeryenhanced_encryptionYesSafety Issue:
- Part A - Number of participants with incidence of antibody formation to heat-shock protein (HSP-70)A test to analyze the formation of antibodies to HSP-70date_rangeTime Frame:Up to 6 weeks after drug administrationenhanced_encryptionYesSafety Issue:
- Part B - Number of participants with incidence of antibody formation to heat-shock protein (HSP-70)A test to analyze the formation of antibodies to HSP-70date_rangeTime Frame:Up to 12 months after drug administrationenhanced_encryptionYesSafety Issue:
- Part C - Number of participants with incidence of antibody formation to heat-shock protein (HSP-70)A test to analyze the formation of antibodies to HSP-70date_rangeTime Frame:before and 3 weeks after surgeryenhanced_encryptionYesSafety Issue:
- Part A - Number of participants with incidence of antibody formation to host cell proteins (HCP)A test to ensure that participants have not developed antibodies to HCP during the studydate_rangeTime Frame:Up to 4 weeks after drug administrationenhanced_encryptionYesSafety Issue:
- Part B - Number of participants with incidence of antibody formation to host cell proteins (HCP)A test to ensure that participants have not developed antibodies to HCP during the studydate_rangeTime Frame:Up to 12 months after drug administrationenhanced_encryptionYesSafety Issue:
- Part C - Number of participants with incidence of antibody formation to host cell proteins (HCP)A test to ensure that participants have not developed antibodies to HCP during the studydate_rangeTime Frame:before and 3 weeks after surgeryenhanced_encryptionYesSafety Issue:
- Part B - Number of participants with assessment of the hemostasis during major surgeryAn assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operationsdate_rangeTime Frame:An average of 1 month after start of treatmentenhanced_encryptionYesSafety Issue:
- Part C - Number of participants with assessment of the hemostasis during major surgeryAn assessment made by surgeons of how effective BAY81-8973 was in stopping bleeding during major operationsdate_rangeTime Frame:at the time of surgeryenhanced_encryptionYesSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
Biological/VaccineTrial Purpose
TreatmentAllocation
RandomizedBlinding
Open LabelAssignment
Crossover AssignmentTrial Arms
5Additional Information
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