Trial Condition(s):
Hemophilia A, Hemophilia B
A Phase 2/ 3 trial to evaluate the efficacy and safety of BAY86-6150
Bayer Identifier:
15534
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
Trial Purpose
Haemophilia is a disorder, usually genetic, affecting mostly male individuals, in which one of the proteins needed to form blood clots (FVIII) is missing or not present in sufficient levels. In a person with haemophilia, the clotting process is much slower and the person experiences bleeding episodes that can result in serious problems and potential disability.
The current haemophilia standard of care is to maintain FVIII activity level above 1%. Sometimes, patients can develop antibodies (so called “inhibitors”) against FVIII and it is no longer effective at controlling bleeds. Bleeds in these patients are currently treated using other proteins involved in the clotting process.
The purpose of this study is to investigate how effectively BAY86-6150 may stop acute bleeds in “inhibitor” patients. This study consists of two parts, A and B. The purpose of part A is to find the most effective yet tolerable out of four doses of BAY86-6150 with regard to efficacy and safety (dose-finding part). Part A is expected to last 9 – 29 months. The purpose of part B is to confirm efficacy and safety of the dose found in part A in all participating patients (confirmatory part). Part B is expected to last 12-32 months.
Approximately 60 male subjects 12 to 62 years-of-age with moderate or severe haemophilia A or B, with inhibitors to FVIII or FIX, who have had 4 or more bleeding episodes in the last 6 months, will participate in this study.
Patient’s bleeds will be treated with BAY86-6150 and with a rescue medication if no response is made to BAY86-6150. Patients will attend the treatment centre at regular intervals and be required to keep an electronic diary.
Inclusion Criteria
- Male subjects - 12 to 62 years-of-age - History of moderate or severe congenital hemophilia A or B with inhibitors to FVIII or FIX - 4 or more bleeding episodes in the last 6 months before enrollment.
Exclusion Criteria
- Clinically relevant coagulation disorder other than congenital hemophilia A or B with inhibitors - History of coronary and/or peripheral atherosclerotic disease - Disseminated intravascular coagulopathy, or stage 2 hypertension - Angina pectoris - Myocardial infarction - Transient ischemic attack - Stroke - Congestive heart failure - Thromboembolic event
Trial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Chaim Sheba Medical Center Tel Hashomer, Israel, 5262000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Debrecen Medical&Health Science Center Debrecen, Hungary, 4032 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations AEK Orszagos Haemophilia Kozpont Budapest, Hungary, 1134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University Medical Center Utrecht UTRECHT, Netherlands, 3508 GA | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Johannes-Gutenberg-Universität Mainz Mainz, Germany, 55131 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Onkologische Schwerpunktpraxis Villingen-Schwenningen, Germany, 78050 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospital Clínico San Borja Arriarán Santiago, Chile, 836-0156 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institute of Blood Pathology and Transfusion medicine Lviv, Ukraine, 79044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Regional Clinical Hospital Odessa, Ukraine, 65025 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institute of Urgent and Recovery Surgery n.a. V.K.Gusak AMS Donetsk, Ukraine, 83045 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of Witwatersrand Johannesburg, South Africa, 2132 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Prinshof Campus Pretoria, South Africa, 0001 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of the Free State Bloemfontein, South Africa | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD Sofia, Bulgaria, 1756 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Haematology Service, Canterbury Health Laboratories Christchurch, New Zealand, 8011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kyung Hee University Hospital at Gangdong Seoul, South Korea, 134-727 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Center of Oncology and Hematology Ekaterinburg, Russia, 620149 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations City Policlinic No 37 St. Petersburg, Russia, 191186 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Hospital no 1 n.a. Prof. S.I. Sergeev Khabarovsk, Russia, 680009 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Aarhus Universitetshospital, Skejby Aarhus N, Denmark, 8200 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations HEMORIO Rio de Janeiro, Brazil, 20211030 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations UNIFESP/EPM Sao Paulo, Brazil, 04023-061 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Alfred Hospital Melbourne, Australia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico Milano, Italy, 20122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations A.O.U. Careggi Firenze, Italy, 50134 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Centro Regional de Enfermedades Oncológicas S.A de C.V San Luis Potosí, Mexico, 78216 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ege Universitesi Tip Fakultesi Izmir, Turkey, 35100 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Istanbul Universitesi Cerrahpasa Tip Fakultesi Istanbul, Turkey, 34098 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Edouard Herriot - Lyon Cedex LYON CEDEX, France, 69437 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hôpital Trousseau - Tours TOURS, France, 37044 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Singapore General Hospital Singapore, Singapore, 169608 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National University Hospital Singapore, Singapore, 119228 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" Guadalajara, Mexico | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St Thomas' Hospital London, United Kingdom, SE1 7EH | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Royal Cornwall Hospital Truro, United Kingdom, TR1 3LJ | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instytut Hematologii i Transfuzjologii Warszawa, Poland, 02-776 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations National Taiwan University Hospital Taipei, Taiwan, China, 10016 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Changhua Christian Hospital Changhua, Taiwan, China, 500 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundación Santa Fe de Bogotá - Hospital Universitario Bogotá, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sahlgrenska Universitetssjukhuset Göteborg, Sweden, 413 45 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Instituto Nacional de Pediatría México D. F., Mexico, 04530 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clínica de la Costa LTDA Barranquilla, Colombia | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Taipei Medical University Hospital Taipei, Taiwan, China, 110 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Oaxaca Site Management Organization S.C. Oaxaca, Mexico, 68000 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hospita Transplantes E J Zerbini (Ex Hosp Brigadeiro) São Paulo, Brazil, 01401901 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinical Emergency Hospital for Children "Louis Turcanu" Timisoara, Romania, 300011 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations S.C. SANADOR SRL Bucharest, Romania, 11026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Fundeni Clinical Institute Bucharest, Romania, 022328 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ogikubo Hospital Suginami, Japan, 167-0035 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Tokyo Medical University Hospital Shinjuku-ku, Japan, 160-0023 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nara Medical University Hospital Kashihara, Japan, 634-8522 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations University of California - Davis Sacramento, United States, 95817 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Sahyadri Super Specialty Hospital Pune , India, 411004 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations St John's Medical College Hospital Bangalore, India, 34 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations CARE Hospital Hyderabad, India, 500034 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Christian Medical College Ludhiana, India, 141008 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Children's Hospital at Erlanger Chattanooga, United States, 37403 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Clinics of Samara State Medical University Samara, Russia, 443079 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Peking Union Medical College Hospital beijing, China, 100730 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Institute of Hematology & Blood Diseases Hospital Chinese Ac Tianjin, China | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Nanfang Hospital. Guangzhou, China, 510515 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Phase 2/3, multicenter, open-label clinical study to assess the safety and efficacy of BAY86-6150 in subjects with hemophilia A or B with inhibitors, composed of 2 Parts (A & B). Part A: Sequential cohorts of four dose levels of the modified rFVIIa BAY86-6150 assessed in a non-controlled dose response design in acutely bleeding subjects and for PK/ PD in an intra-individual crossover design compared with one fixed dose of eptacog alfa in non-bleeding subjects. Part B: Confirmatory study to further investigate the efficacy and safety of BAY86-6150
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Crossover Assignment
Trial Arms:
3
Primary Outcome
- Successful treatments of bleeding episodes.A bleed was defined as successfully treated, if no administration of rescue medication was required.Timeframe: 10 hours after each bleed
- Proportion of successful treatments of bleeding episodes on subject level.Proportion of successful treatments of bleeding episodes was calculated as number of bleeding episodes treated successfully - without rescue medication - divided by the total number of bleeding episodes on a dose level.Timeframe: 10 hours after each bleed
Secondary Outcome
- Time to stop the bleedTimeframe: 10 hours after each bleed
- Number of injections needed to stop the bleeding episode.Timeframe: 10 hours after each bleed
- Effectiveness of treatment as rated by the subject's assessment (very effective, effective, partially effective, not effective).Timeframe: 10 hours after each bleed
- Participant's reported outcome as assessed by Euro QoL (EQ-5D).Timeframe: 14 days after last exposure to BAY86-6150
- Participant's reported outcome as assessed by Brief Pain Inventory.Timeframe: 7 days after last exposure to BAY86-6150
- Participant's reported outcome as assessed by Work Productivity and Activity Impairment Questionaire.Timeframe: 14 days after last exposure to BAY86-6150
Additional Information
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