check_circleStudy Completed

Hemophilia A

Bayer Identifier:

14319

ClinicalTrials.gov Identifier:

NCT01233258

EudraCT Number:

2009-012150-20

EU CT Number:

Not Available
A trial to compare prophylaxis therapy to on-demand therapy with a new full length recombinant FVIII in patients with severe Hemophilia A

Trial purpose

The objective of the trial is to demonstrate that 2-3 times per week prophylaxis therapy with BAY81-8973 is superior to on-demand therapy with BAY81-8973 in patients with severe Hemophilia A. The hypothesis is that prophylaxis will result in fewer bleeds than on-demand treatment.

Key Participants Requirements

Sex

Male

Age

12 - 65 Years
  • - Male, aged 12 to 65 years
    - Severe hemophilia A
    - History of more than 150 exposure days (ED) with clotting factor concentrates
    - Currently receiving episodic treatment with FVIII; no regular prophylaxis for more than 6 consecutive months in the past 5 years
    - No current Factor VIII inhibitor or history of inhibitor
    - Willing to use electronic patient diary
  • - Presence of another bleeding disease that is different from hemophilia A
    - Thrombocytopenia
    - Abnormal renal function
    - Presence of active liver disease
    - Known hypersensitivity to FVIII

Trial summary

Enrollment Goal
80
Trial Dates
January 2011 - December 2012
Phase
Phase 3
Could I Receive a placebo
No
Products
Kovaltry (Antihemophilic Factor [Recombinant], BAY81-8973)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Dayton, 45404, United States
Completed
Shinjuku-ku, 160-0023, Japan
Completed
Suginami, 167-0035, Japan
Completed
Kashihara, 634-8522, Japan
Terminated
Nishinomiya, 663-8501, Japan
Completed
Hiroshima, 734-8551, Japan
Completed
San Luis Potosí, 78200, Mexico
Completed
Guadalajara, 44280, Mexico
Completed
Johannesburg, 2193, South Africa
Completed
Pretoria, 0001, South Africa
Terminated
Buenos Aires, C1221ADC, Argentina
Terminated
Corrientes, W3410AVV, Argentina
Completed
Yekaterinburg, 620149, Russia
Completed
St. Petersburg, 191186, Russia
Terminated
Barnaul, 656050, Russia
Terminated
Bratislava, 851 07, Slovakia
Terminated
Jakarta, 10430, Indonesia
Terminated
Jakarta, 10430, Indonesia
Terminated
Hyderabad, 500034, India
Completed
Taichung, 40447, Taiwan
Terminated
Taipei, 11217, Taiwan
Terminated
Bangkok, 10700, Thailand
Terminated
Bangkok, 10400, Thailand
Completed
Houston, 77030, United States
Completed
Olomouc, 77520, Czech Republic
Terminated
Khabarovsk, 680009, Russia
Completed
Izmir, 35-100, Turkey
Completed
Adana, 01330, Turkey
Completed
Antalya, 07059, Turkey
Completed
Beograd, 11000, Serbia
Completed
Nis, 18000, Serbia
Completed
Timisoara, 300011, Romania
Completed
Bucharest, 011026, Romania
Completed
Bucharest, 022328, Romania
Completed
Baia Mare, 430031, Romania
Terminated
Rosario, S2000CKF, Argentina
Terminated
Lviv, 79044, Ukraine
Terminated
Simferopol, 95023, Ukraine
Terminated
Kiev, Ukraine
Terminated
Nis, 18000, Serbia
Completed
Novi Sad, 21000, Serbia
Completed
Kragujevac, 34000, Serbia
Terminated
Beograd, 11000, Serbia
Completed
Beijing, 100730, China
Completed
Tianjin, 300020, China
Completed
Shanghai, 200025, China
Completed
Suzhou, 215006, China
Completed
Guangzhou, 510515, China
Terminated
Bogotá, Colombia
Terminated
Bucaramanga, Colombia

Primary Outcome

  • Annualized number of all bleeds
    date_rangeTime Frame:
    Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Annualized number of all bleeds during CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) period
    date_rangeTime Frame:
    Up to 6 months (6 months on CS/EP potency assignment)
    enhanced_encryption
    Safety Issue:
    No
  • Annualized number of all bleeds during CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) period
    date_rangeTime Frame:
    Up to 6 months (6 months on CS/ADJ potency assignment)
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of bleeds per participant controlled with ≤ 2 injections in participants treated on demand with rFVIII (BAY81-8973)
    date_rangeTime Frame:
    Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)
    enhanced_encryption
    Safety Issue:
    No

Trial design

A phase II/III, randomized, cross-over, open-label trial to demonstrate superiority of prophylaxis over on-demand therapy in previously treated subjects with severe hemophilia A treated with plasma protein-free recombinant FVIII formulated with sucrose (BAY 81-8973)
Trial Type
Interventional
Intervention Type
Biological/Vaccine
Trial Purpose
Treatment
Allocation
Randomized
Blinding
Open Label
Assignment
Crossover Assignment
Trial Arms
6

Additional Information

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