check_circleStudy Completed

Hemophilia A, Hemophilia B

Bayer Identifier:

15534

ClinicalTrials.gov Identifier:

NCT01625390

EudraCT Number:

2011-000323-33

EU CT Number:

Not Available
A Phase 2/ 3 trial to evaluate the efficacy and safety of BAY86-6150

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.

Key Participants Requirements

Sex

Male

Age

12 - 62 Years
  • - 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.
  • - 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
10
Trial Dates
June 2012 - March 2014
Phase
Phase 2/3
Could I Receive a placebo
No
Products
BAY86-6150
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Terminated
Chaim Sheba Medical CenterTel Hashomer, 5262000, Israel
Terminated
University of Debrecen Medical&Health Science CenterDebrecen, 4032, Hungary
Terminated
AEK Orszagos Haemophilia KozpontBudapest, 1134, Hungary
Terminated
University Medical Center UtrechtUTRECHT, 3508 GA, Netherlands
Terminated
Johannes-Gutenberg-Universität MainzMainz, 55131, Germany
Terminated
Onkologische SchwerpunktpraxisVillingen-Schwenningen, 78050, Germany
Terminated
Hospital Clínico San Borja ArriaránSantiago, 836-0156, Chile
Completed
Institute of Blood Pathology and Transfusion medicineLviv, 79044, Ukraine
Terminated
Regional Clinical HospitalOdessa, 65025, Ukraine
Terminated
Institute of Urgent and Recovery Surgery n.a. V.K.Gusak AMSDonetsk, 83045, Ukraine
Completed
University of WitwatersrandJohannesburg, 2132, South Africa
Terminated
Prinshof CampusPretoria, 0001, South Africa
Terminated
University of the Free StateBloemfontein, South Africa
Completed
SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EADSofia, 1756, Bulgaria
Terminated
Haematology Service, Canterbury Health LaboratoriesChristchurch, 8011, New Zealand
Completed
Kyung Hee University Hospital at GangdongSeoul, 134-727, Korea, Republic Of
Terminated
Children's Center of Oncology and HematologyEkaterinburg, 620149, Russia
Terminated
City Policlinic No 37St. Petersburg, 191186, Russia
Terminated
Clinical Hospital no 1 n.a. Prof. S.I. SergeevKhabarovsk, 680009, Russia
Terminated
Aarhus Universitetshospital, SkejbyAarhus N, 8200, Denmark
Terminated
HEMORIORio de Janeiro, 20211030, Brazil
Terminated
UNIFESP/EPMSao Paulo, 04023-061, Brazil
Terminated
The Alfred HospitalMelbourne, Australia
Terminated
IRCCS Fondazione Ca' Granda Ospedale Maggiore PoliclinicoMilano, 20122, Italy
Terminated
A.O.U. CareggiFirenze, 50134, Italy
Terminated
Centro Regional de Enfermedades Oncológicas S.A de C.VSan Luis Potosí, 78216, Mexico
Completed
Ege Universitesi Tip FakultesiIzmir, 35100, Turkey
Completed
Istanbul Universitesi Cerrahpasa Tip FakultesiIstanbul, 34098, Turkey
Terminated
Hôpital Edouard Herriot - Lyon CedexLYON CEDEX, 69437, France
Terminated
Hôpital Trousseau - ToursTOURS, 37044, France
Completed
Singapore General HospitalSingapore, 169608, Singapore
Completed
National University HospitalSingapore, 119228, Singapore
Terminated
Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"Guadalajara, Mexico
Terminated
St Thomas' HospitalLondon, SE1 7EH, United Kingdom
Terminated
Royal Cornwall HospitalTruro, TR1 3LJ, United Kingdom
Completed
Instytut Hematologii i TransfuzjologiiWarszawa, 02-776, Poland
Terminated
National Taiwan University HospitalTaipei, 10016, Taiwan
Terminated
Changhua Christian HospitalChanghua, 500, Taiwan
Terminated
Fundación Santa Fe de Bogotá - Hospital UniversitarioBogotá, Colombia
Terminated
Sahlgrenska UniversitetssjukhusetGöteborg, 413 45, Sweden
Terminated
Instituto Nacional de PediatríaMéxico D. F., 04530, Mexico
Terminated
Clínica de la Costa LTDABarranquilla, Colombia
Terminated
Taipei Medical University HospitalTaipei, 110, Taiwan
Terminated
Oaxaca Site Management Organization S.C.Oaxaca, 68000, Mexico
Terminated
Hospita Transplantes E J Zerbini (Ex Hosp Brigadeiro)São Paulo, 01401901, Brazil
Terminated
Clinical Emergency Hospital for Children "Louis Turcanu"Timisoara, 300011, Romania
Terminated
S.C. SANADOR SRLBucharest, 11026, Romania
Terminated
Fundeni Clinical InstituteBucharest, 022328, Romania
Terminated
Ogikubo HospitalSuginami, 167-0035, Japan
Terminated
Tokyo Medical University HospitalShinjuku-ku, 160-0023, Japan
Terminated
Nara Medical University HospitalKashihara, 634-8522, Japan
Terminated
University of California - DavisSacramento, 95817, United States
Terminated
Sahyadri Super Specialty HospitalPune, 411004, India
Terminated
St John's Medical College HospitalBangalore, 34, India
Terminated
CARE HospitalHyderabad, 500034, India
Terminated
Christian Medical CollegeLudhiana, 141008, India
Terminated
Children's Hospital at ErlangerChattanooga, 37403, United States
Terminated
Clinics of Samara State Medical UniversitySamara, 443079, Russia
Terminated
Peking Union Medical College Hospitalbeijing, 100730, China
Terminated
Institute of Hematology & Blood Diseases Hospital Chinese AcTianjin, China
Terminated
Nanfang Hospital.Guangzhou, 510515, China

Primary Outcome

  • Successful treatments of bleeding episodes.
    A bleed was defined as successfully treated, if no administration of rescue medication was required.
    date_rangeTime Frame:
    10 hours after each bleed
    enhanced_encryption
    Safety Issue:
    No
  • 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.
    date_rangeTime Frame:
    10 hours after each bleed
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Time to stop the bleed
    date_rangeTime Frame:
    10 hours after each bleed
    enhanced_encryption
    Safety Issue:
    No
  • Number of injections needed to stop the bleeding episode.
    date_rangeTime Frame:
    10 hours after each bleed
    enhanced_encryption
    Safety Issue:
    No
  • Effectiveness of treatment as rated by the subject's assessment (very effective, effective, partially effective, not effective).
    date_rangeTime Frame:
    10 hours after each bleed
    enhanced_encryption
    Safety Issue:
    No
  • Participant's reported outcome as assessed by Euro QoL (EQ-5D).
    date_rangeTime Frame:
    14 days after last exposure to BAY86-6150
    enhanced_encryption
    Safety Issue:
    No
  • Participant's reported outcome as assessed by Brief Pain Inventory.
    date_rangeTime Frame:
    7 days after last exposure to BAY86-6150
    enhanced_encryption
    Safety Issue:
    No
  • Participant's reported outcome as assessed by Work Productivity and Activity Impairment Questionaire.
    date_rangeTime Frame:
    14 days after last exposure to BAY86-6150
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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