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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01625390




Registration number
NCT01625390
Ethics application status
Date submitted
19/06/2012
Date registered
21/06/2012
Date last updated
1/07/2015

Titles & IDs
Public title
A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150
Scientific title
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
Secondary ID [1] 0 0
2011-000323-33
Secondary ID [2] 0 0
15534
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hemophilia A, Hemophilia B 0 0
Condition category
Condition code
Blood 0 0 0 0
Clotting disorders
Human Genetics and Inherited Disorders 0 0 0 0
Other human genetics and inherited disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - BAY86-6150
Treatment: Drugs - eptacog alfa [activated]
Treatment: Drugs - BAY86-6150

Experimental: Arm 1 -

Active comparator: Arm 2 -

Experimental: Arm 3 -


Treatment: Drugs: 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.

Treatment: Drugs: eptacog alfa [activated]
comparative PK/PD (pharmacokinetics/pharmacodynamics) evaluation

Treatment: Drugs: BAY86-6150
Confirmation of recommended dose of BAY86-6150 to be evaluated further as determined in Part A.
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Successful treatments of bleeding episodes.
Timepoint [1] 0 0
10 hours after each bleed
Primary outcome [2] 0 0
Proportion of successful treatments of bleeding episodes on subject level.
Timepoint [2] 0 0
10 hours after each bleed
Secondary outcome [1] 0 0
Time to stop the bleed
Timepoint [1] 0 0
10 hours after each bleed
Secondary outcome [2] 0 0
Number of injections needed to stop the bleeding episode.
Timepoint [2] 0 0
10 hours after each bleed
Secondary outcome [3] 0 0
Effectiveness of treatment as rated by the subject's assessment (very effective, effective, partially effective, not effective).
Timepoint [3] 0 0
10 hours after each bleed
Secondary outcome [4] 0 0
Participant's reported outcome as assessed by Euro QoL (EQ-5D).
Timepoint [4] 0 0
14 days after last exposure to BAY86-6150
Secondary outcome [5] 0 0
Participant's reported outcome as assessed by Brief Pain Inventory.
Timepoint [5] 0 0
7 days after last exposure to BAY86-6150
Secondary outcome [6] 0 0
Participant's reported outcome as assessed by Work Productivity and Activity Impairment Questionaire.
Timepoint [6] 0 0
14 days after last exposure to BAY86-6150

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
62 Years
Sex
Males
Can healthy volunteers participate?
No
Key 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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Phase 2
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/06/2012
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/03/2014
Sample size
Target
Accrual to date
Final
10
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
- Melbourne
Recruitment postcode(s) [1] 0 0
- Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Tennessee
Country [3] 0 0
Brazil
State/province [3] 0 0
Sao Paulo
Country [4] 0 0
Brazil
State/province [4] 0 0
Rio de Janeiro
Country [5] 0 0
Bulgaria
State/province [5] 0 0
Sofia
Country [6] 0 0
Chile
State/province [6] 0 0
Santiago
Country [7] 0 0
China
State/province [7] 0 0
Guangdong
Country [8] 0 0
China
State/province [8] 0 0
Beijing
Country [9] 0 0
China
State/province [9] 0 0
Tianjin
Country [10] 0 0
Colombia
State/province [10] 0 0
Atlántico
Country [11] 0 0
Colombia
State/province [11] 0 0
Bogotá
Country [12] 0 0
Denmark
State/province [12] 0 0
Aarhus N
Country [13] 0 0
France
State/province [13] 0 0
Lyon Cedex
Country [14] 0 0
France
State/province [14] 0 0
Tours
Country [15] 0 0
Germany
State/province [15] 0 0
Baden-Württemberg
Country [16] 0 0
Germany
State/province [16] 0 0
Rheinland-Pfalz
Country [17] 0 0
Hungary
State/province [17] 0 0
Budapest
Country [18] 0 0
Hungary
State/province [18] 0 0
Debrecen
Country [19] 0 0
India
State/province [19] 0 0
Andhra Pradesh
Country [20] 0 0
India
State/province [20] 0 0
Punjab
Country [21] 0 0
India
State/province [21] 0 0
Bangalore
Country [22] 0 0
India
State/province [22] 0 0
Pune
Country [23] 0 0
Israel
State/province [23] 0 0
Tel Hashomer
Country [24] 0 0
Italy
State/province [24] 0 0
Firenze
Country [25] 0 0
Italy
State/province [25] 0 0
Milano
Country [26] 0 0
Japan
State/province [26] 0 0
Nara
Country [27] 0 0
Japan
State/province [27] 0 0
Tokyo
Country [28] 0 0
Korea, Republic of
State/province [28] 0 0
Seoul
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Mexico
State/province [29] 0 0
Jalisco
Country [30] 0 0
Mexico
State/province [30] 0 0
México D. F.
Country [31] 0 0
Mexico
State/province [31] 0 0
Oaxaca
Country [32] 0 0
Mexico
State/province [32] 0 0
San Luis Potosí
Country [33] 0 0
Netherlands
State/province [33] 0 0
Utrecht
Country [34] 0 0
New Zealand
State/province [34] 0 0
Christchurch
Country [35] 0 0
Poland
State/province [35] 0 0
Warszawa
Country [36] 0 0
Romania
State/province [36] 0 0
Timis
Country [37] 0 0
Romania
State/province [37] 0 0
Bucharest
Country [38] 0 0
Russian Federation
State/province [38] 0 0
Ekaterinburg
Country [39] 0 0
Russian Federation
State/province [39] 0 0
Khabarovsk
Country [40] 0 0
Russian Federation
State/province [40] 0 0
Samara
Country [41] 0 0
Russian Federation
State/province [41] 0 0
St. Petersburg
Country [42] 0 0
Singapore
State/province [42] 0 0
Singapore
Country [43] 0 0
South Africa
State/province [43] 0 0
Freestate
Country [44] 0 0
South Africa
State/province [44] 0 0
Gauteng
Country [45] 0 0
Sweden
State/province [45] 0 0
Göteborg
Country [46] 0 0
Taiwan
State/province [46] 0 0
Changhua
Country [47] 0 0
Taiwan
State/province [47] 0 0
Taipei
Country [48] 0 0
Turkey
State/province [48] 0 0
Istanbul
Country [49] 0 0
Turkey
State/province [49] 0 0
Izmir
Country [50] 0 0
Ukraine
State/province [50] 0 0
Donetsk
Country [51] 0 0
Ukraine
State/province [51] 0 0
Lviv
Country [52] 0 0
Ukraine
State/province [52] 0 0
Odessa
Country [53] 0 0
United Kingdom
State/province [53] 0 0
London
Country [54] 0 0
United Kingdom
State/province [54] 0 0
Truro

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Bayer
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Bayer Study Director
Address 0 0
Bayer
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01625390