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A Phase 2/ 3 Trial to Evaluate the Efficacy and Safety of BAY86-6150

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01625390
Recruitment Status : Completed
First Posted : June 21, 2012
Last Update Posted : July 1, 2015
Information provided by (Responsible Party):

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hemophilia A, Hemophilia B Drug: BAY86-6150 Drug: eptacog alfa [activated] Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official 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
Study Start Date : June 2012
Actual Primary Completion Date : March 2014
Actual Study Completion Date : March 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding Hemophilia

Arm Intervention/treatment
Experimental: Arm 1 Drug: 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.

Active Comparator: Arm 2 Drug: eptacog alfa [activated]
comparative PK/PD (pharmacokinetics/pharmacodynamics) evaluation

Experimental: Arm 3 Drug: BAY86-6150
Confirmation of recommended dose of BAY86-6150 to be evaluated further as determined in Part A.

Primary Outcome Measures :
  1. Successful treatments of bleeding episodes. [ Time Frame: 10 hours after each bleed ]
    A bleed was defined as successfully treated, if no administration of rescue medication was required.

  2. Proportion of successful treatments of bleeding episodes on subject level. [ Time Frame: 10 hours after each bleed ]
    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.

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

Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 62 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01625390

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Sponsors and Collaborators
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Study Director: Bayer Study Director Bayer

Additional Information:
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Responsible Party: Bayer Identifier: NCT01625390     History of Changes
Other Study ID Numbers: 15534
2011-000323-33 ( EudraCT Number )
U1111-1133-2156 ( Other Identifier: WHO - Universal Trial Number (UTN) )
First Posted: June 21, 2012    Key Record Dates
Last Update Posted: July 1, 2015
Last Verified: June 2015
Keywords provided by Bayer:
hemophilia, haemophilia, inhibitor, FVIIa, Factor VII activated, bypassing
Additional relevant MeSH terms:
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Hemophilia A
Hemophilia B
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
Hemorrhagic Disorders
Genetic Diseases, Inborn
Genetic Diseases, X-Linked