Trial Condition(s):
Hemophilia A
A trial to compare prophylaxis therapy to on-demand therapy with a new full length recombinant FVIII in patients with severe Hemophilia A (Leopold II)
Bayer Identifier:
14319
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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.
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | Status | |
|---|---|---|
Locations Investigative Site Dayton, United States, 45404 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shinjuku-ku, Japan, 160-0023 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suginami, Japan, 167-0035 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kashihara, Japan, 634-8522 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nishinomiya, Japan, 663-8501 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hiroshima, Japan, 734-8551 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site San Luis Potosí, Mexico, 78200 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guadalajara, Mexico, 44280 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Johannesburg, South Africa, 2193 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Pretoria, South Africa, 0001 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Buenos Aires, Argentina, C1221ADC | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Corrientes, Argentina, W3410AVV | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Yekaterinburg, Russia, 620149 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site St. Petersburg, Russia, 191186 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Barnaul, Russia, 656050 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bratislava, Slovakia, 851 07 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Jakarta, Indonesia, 10430 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Hyderabad, India, 500034 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taichung, Taiwan, China, 40447 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Taipei, Taiwan, China, 11217 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bangkok, Thailand, 10700 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bangkok, Thailand, 10400 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Houston, United States, 77030 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Olomouc, Czech Republic, 77520 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Khabarovsk, Russia, 680009 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Izmir, Turkey, 35-100 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Adana, Turkey, 01330 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Antalya, Turkey, 07059 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beograd, Serbia, 11000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nis, Serbia, 18000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Timisoara, Romania, 300011 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bucharest, Romania, 011026 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bucharest, Romania, 022328 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Baia Mare, Romania, 430031 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Rosario, Argentina, S2000CKF | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Lviv, Ukraine, 79044 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Simferopol, Ukraine, 95023 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kiev, Ukraine | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Nis, Serbia, 18000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Novi Sad, Serbia, 21000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Kragujevac, Serbia, 34000 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beograd, Serbia, 11000 | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Beijing, China, 100730 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Tianjin, China, 300020 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Shanghai, China, 200025 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Suzhou, China, 215006 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Guangzhou, China, 510515 | Status Completed | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bogotá, Colombia | Status Terminated | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Investigative Site Bucaramanga, Colombia | Status Terminated | Contact Us: E-mail: clinica[email protected] Phone: Not Available |
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
Primary Outcome
- Annualized number of all bleedsTimeframe: Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)
Secondary Outcome
- Annualized number of all bleeds during CS/EP (Chromogenic Substrate Assay per European Pharmacopoeia) periodTimeframe: Up to 6 months (6 months on CS/EP potency assignment)
- Annualized number of all bleeds during CS/ADJ (Chromogenic Substrate Assay/label adjusted to one-stage assay) periodTimeframe: Up to 6 months (6 months on CS/ADJ potency assignment)
- Percentage of bleeds per participant controlled with ≤ 2 injections in participants treated on demand with rFVIII (BAY81-8973)Timeframe: Up to 12 months (6 months per mode of potency assignment according to the randomized cross-over design)
Additional Information
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