A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150
NCT ID: NCT01625390
Last Updated: 2015-07-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2/PHASE3
10 participants
INTERVENTIONAL
2012-06-30
2014-03-31
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Arm 1
BAY86-6150
Four dose levels (6.5 µg/kg, 20 µg/kg, 50 µg/kg and 90 µg/kg) of BAY86-6150 will be studied.
Arm 2
eptacog alfa [activated]
comparative PK/PD (pharmacokinetics/pharmacodynamics) evaluation
Arm 3
BAY86-6150
Confirmation of recommended dose of BAY86-6150 to be evaluated further as determined in Part A.
Interventions
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BAY86-6150
Four dose levels (6.5 µg/kg, 20 µg/kg, 50 µg/kg and 90 µg/kg) of BAY86-6150 will be studied.
eptacog alfa [activated]
comparative PK/PD (pharmacokinetics/pharmacodynamics) evaluation
BAY86-6150
Confirmation of recommended dose of BAY86-6150 to be evaluated further as determined in Part A.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
12 Years
62 Years
MALE
No
Sponsors
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Bayer
INDUSTRY
Responsible Party
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Principal Investigators
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Bayer Study Director
Role: STUDY_DIRECTOR
Bayer
Locations
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Sacramento, California, United States
Chattanooga, Tennessee, United States
Melbourne, Victoria, Australia
Rio de Janeiro, Rio de Janeiro, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Sofia, , Bulgaria
Santiago, , Chile
Guangzhou, Guangdong, China
Beijing, , China
Tianjin, , China
Barranquilla, Atlántico, Colombia
Bogotá, , Colombia
Aarhus N, , Denmark
Lyon, , France
Tours, , France
Villingen-Schwenningen, Baden-Wurttemberg, Germany
Mainz, Rhineland-Palatinate, Germany
Budapest, , Hungary
Debrecen, , Hungary
Hyderabad, Andhra Pradesh, India
Ludhiana, Punjab, India
Bangalore, , India
Pune, , India
Tel Litwinsky, , Israel
Florence, , Italy
Milan, , Italy
Kashihara, Nara, Japan
Shinjuku-ku, Tokyo, Japan
Suginami, Tokyo, Japan
Guadalajara, Jalisco, Mexico
Oaxaca City, Oaxaca, Mexico
San Luis Potosí City, San Luis Potosí, Mexico
México D. F., , Mexico
Utrecht, , Netherlands
Christchurch, , New Zealand
Warsaw, , Poland
Timișoara, Timiș County, Romania
Bucharest, , Romania
Bucharest, , Romania
Khabarovsk, , Russia
Saint Petersburg, , Russia
Samara, , Russia
Yekaterinburg, , Russia
Singapore, , Singapore
Singapore, , Singapore
Bloemfontein, Freestate, South Africa
Johannesburg, Gauteng, South Africa
Pretoria, Gauteng, South Africa
Seoul, , South Korea
Gothenburg, , Sweden
Taipei, Taipei, Taiwan
Changhua, , Taiwan
Taipei, , Taiwan
Istanbul, , Turkey (Türkiye)
Izmir, , Turkey (Türkiye)
Donetsk, , Ukraine
Lviv, , Ukraine
Odesa, , Ukraine
London, , United Kingdom
Truro, , United Kingdom
Countries
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Other Identifiers
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15534
Identifier Type: -
Identifier Source: org_study_id
2011-000323-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
U1111-1133-2156
Identifier Type: OTHER
Identifier Source: secondary_id
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