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:

NCT01625390

EudraCT Number:

2011-000323-33

Study Completed

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
10
Trial Dates
black-arrow
Phase
2/3
Could I receive a placebo?
No
Products
BAY86-6150
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Chaim Sheba Medical Center

Tel Hashomer, Israel, 5262000

Status
Terminated
 
Locations

University of Debrecen Medical&Health Science Center

Debrecen, Hungary, 4032

Status
Terminated
 
Locations

AEK Orszagos Haemophilia Kozpont

Budapest, Hungary, 1134

Status
Terminated
 
Locations

University Medical Center Utrecht

UTRECHT, Netherlands, 3508 GA

Status
Terminated
 
Locations

Johannes-Gutenberg-Universität Mainz

Mainz, Germany, 55131

Status
Terminated
 
Locations

Onkologische Schwerpunktpraxis

Villingen-Schwenningen, Germany, 78050

Status
Terminated
 
Locations

Hospital Clínico San Borja Arriarán

Santiago, Chile, 836-0156

Status
Terminated
 
Locations

Institute of Blood Pathology and Transfusion medicine

Lviv, Ukraine, 79044

Status
Completed
 
Locations

Regional Clinical Hospital

Odessa, Ukraine, 65025

Status
Terminated
 
Locations

Institute of Urgent and Recovery Surgery n.a. V.K.Gusak AMS

Donetsk, Ukraine, 83045

Status
Terminated
 
Locations

University of Witwatersrand

Johannesburg, South Africa, 2132

Status
Completed
 
Locations

Prinshof Campus

Pretoria, South Africa, 0001

Status
Terminated
 
Locations

University of the Free State

Bloemfontein, South Africa

Status
Terminated
 
Locations

SHATHD Spec. Hospi. for Active Treatm. of Haematol. Dis. EAD

Sofia, Bulgaria, 1756

Status
Completed
 
Locations

Haematology Service, Canterbury Health Laboratories

Christchurch, New Zealand, 8011

Status
Terminated
 
Locations

Kyung Hee University Hospital at Gangdong

Seoul, South Korea, 134-727

Status
Completed
 
Locations

Children's Center of Oncology and Hematology

Ekaterinburg, Russia, 620149

Status
Terminated
 
Locations

City Policlinic No 37

St. Petersburg, Russia, 191186

Status
Terminated
 
Locations

Clinical Hospital no 1 n.a. Prof. S.I. Sergeev

Khabarovsk, Russia, 680009

Status
Terminated
 
Locations

Aarhus Universitetshospital, Skejby

Aarhus N, Denmark, 8200

Status
Terminated
 
Locations

HEMORIO

Rio de Janeiro, Brazil, 20211030

Status
Terminated
 
Locations

UNIFESP/EPM

Sao Paulo, Brazil, 04023-061

Status
Terminated
 
Locations

The Alfred Hospital

Melbourne, Australia

Status
Terminated
 
Locations

IRCCS Fondazione Ca' Granda Ospedale Maggiore Policlinico

Milano, Italy, 20122

Status
Terminated
 
Locations

A.O.U. Careggi

Firenze, Italy, 50134

Status
Terminated
 
Locations

Centro Regional de Enfermedades Oncológicas S.A de C.V

San Luis Potosí, Mexico, 78216

Status
Terminated
 
Locations

Ege Universitesi Tip Fakultesi

Izmir, Turkey, 35100

Status
Completed
 
Locations

Istanbul Universitesi Cerrahpasa Tip Fakultesi

Istanbul, Turkey, 34098

Status
Completed
 
Locations

Hôpital Edouard Herriot - Lyon Cedex

LYON CEDEX, France, 69437

Status
Terminated
 
Locations

Hôpital Trousseau - Tours

TOURS, France, 37044

Status
Terminated
 
Locations

Singapore General Hospital

Singapore, Singapore, 169608

Status
Completed
 
Locations

National University Hospital

Singapore, Singapore, 119228

Status
Completed
 
Locations

Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde"

Guadalajara, Mexico

Status
Terminated
 
Locations

St Thomas' Hospital

London, United Kingdom, SE1 7EH

Status
Terminated
 
Locations

Royal Cornwall Hospital

Truro, United Kingdom, TR1 3LJ

Status
Terminated
 
Locations

Instytut Hematologii i Transfuzjologii

Warszawa, Poland, 02-776

Status
Completed
 
Locations

National Taiwan University Hospital

Taipei, Taiwan, China, 10016

Status
Terminated
 
Locations

Changhua Christian Hospital

Changhua, Taiwan, China, 500

Status
Terminated
 
Locations

Fundación Santa Fe de Bogotá - Hospital Universitario

Bogotá, Colombia

Status
Terminated
 
Locations

Sahlgrenska Universitetssjukhuset

Göteborg, Sweden, 413 45

Status
Terminated
 
Locations

Instituto Nacional de Pediatría

México D. F., Mexico, 04530

Status
Terminated
 
Locations

Clínica de la Costa LTDA

Barranquilla, Colombia

Status
Terminated
 
Locations

Taipei Medical University Hospital

Taipei, Taiwan, China, 110

Status
Terminated
 
Locations

Oaxaca Site Management Organization S.C.

Oaxaca, Mexico, 68000

Status
Terminated
 
Locations

Hospita Transplantes E J Zerbini (Ex Hosp Brigadeiro)

São Paulo, Brazil, 01401901

Status
Terminated
 
Locations

Clinical Emergency Hospital for Children "Louis Turcanu"

Timisoara, Romania, 300011

Status
Terminated
 
Locations

S.C. SANADOR SRL

Bucharest, Romania, 11026

Status
Terminated
 
Locations

Fundeni Clinical Institute

Bucharest, Romania, 022328

Status
Terminated
 
Locations

Ogikubo Hospital

Suginami, Japan, 167-0035

Status
Terminated
 
Locations

Tokyo Medical University Hospital

Shinjuku-ku, Japan, 160-0023

Status
Terminated
 
Locations

Nara Medical University Hospital

Kashihara, Japan, 634-8522

Status
Terminated
 
Locations

University of California - Davis

Sacramento, United States, 95817

Status
Terminated
 
Locations

Sahyadri Super Specialty Hospital

Pune , India, 411004

Status
Terminated
 
Locations

St John's Medical College Hospital

Bangalore, India, 34

Status
Terminated
 
Locations

CARE Hospital

Hyderabad, India, 500034

Status
Terminated
 
Locations

Christian Medical College

Ludhiana, India, 141008

Status
Terminated
 
Locations

Children's Hospital at Erlanger

Chattanooga, United States, 37403

Status
Terminated
 
Locations

Clinics of Samara State Medical University

Samara, Russia, 443079

Status
Terminated
 
Locations

Peking Union Medical College Hospital

beijing, China, 100730

Status
Terminated
 
Locations

Institute of Hematology & Blood Diseases Hospital Chinese Ac

Tianjin, China

Status
Terminated
 
Locations

Nanfang Hospital.

Guangzhou, China, 510515

Status
Terminated
 

Trial Design