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)
This study has been completed.
Sponsor:
Bayer
Information provided by:
Bayer
ClinicalTrials.gov Identifier:
NCT01233258
First received: November 2, 2010
Last updated: January 25, 2013
Last verified: January 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hemophilia A |
Biological: Recombinant Factor VIII (BAY81-8973) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | 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 BAY81-8973 (rFVIII Formulated With Sucrose) |
Resource links provided by NLM:
Genetics Home Reference related topics:
hemophilia
MedlinePlus related topics:
Hemophilia
U.S. FDA Resources
Further study details as provided by Bayer:
Primary Outcome Measures:
- Annualized number of all bleeds [ Time Frame: 12 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Annualized number of all bleeds with 2 potency assignments [ Time Frame: 12 months ] [ Designated as safety issue: No ]
- Response to treatment of bleeds as measured by proportion of bleeds treated with 1 or 2 infusions [ Time Frame: 12 months ] [ Designated as safety issue: No ]
| Enrollment: | 80 |
| Study Start Date: | January 2011 |
| Study Completion Date: | December 2012 |
| Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Arm 1 |
Biological: Recombinant Factor VIII (BAY81-8973)
On-demand treatment with BAY81-8973 assayed by CS/EP (Chromogenic substrate/European Pharmacopoeia assay) for 6 months, followed by cross-over to BAY81-8973 assayed by CS/ADJ (Chromogenic substrate/one-stage adjusted assay) for 6 months.
|
| Experimental: Arm 2 |
Biological: Recombinant Factor VIII (BAY81-8973)
Prophylaxis with high-dose BAY81-8973 assayed by CS/EP for 6 months, followed by cross-over to BAY81-8973 assayed by CS/ADJ for 6 months.
|
| Experimental: Arm 3 |
Biological: Recombinant Factor VIII (BAY81-8973)
Prophylaxis with low-dose BAY81-8973 assayed by CS/EP for 6 months, followed by cross-over to BAY81-8973 assayed by CS/ADJ for 6 months.
|
| Experimental: Arm 4 |
Biological: Recombinant Factor VIII (BAY81-8973)
Prophylaxis with high-dose BAY81-8973 assayed by CS/ADJ for 6 months, followed by cross-over to BAY81-8973 assayed by CS/EP for 6 months.
|
| Experimental: Arm 5 |
Biological: Recombinant Factor VIII (BAY81-8973)
Prophylaxis with low-dose BAY81-8973 assayed by CS/ADJ for 6 months, followed by cross-over to BAY81-8973 assayed by CS/EP for 6 months.
|
| Experimental: Arm 6 |
Biological: Recombinant Factor VIII (BAY81-8973)
On-demand treatment with BAY81-8973 assayed by CS/ADJ for 6 months, followed by cross-over to BAY81-8973 assayed by CS/EP for 6 months .
|
Eligibility| Ages Eligible for Study: | 12 Years to 65 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01233258
Hide Study Locations
Hide Study LocationsLocations
| United States, Ohio | |
| Dayton, Ohio, United States, 45404 | |
| United States, Texas | |
| Houston, Texas, United States, 77030 | |
| Argentina | |
| Buenos Aires, Ciudad Auton. de Buenos Aires, Argentina, C1221ADC | |
| Rosario, Santa Fe, Argentina, S2000CKF | |
| Corrientes, Argentina, W3410AVV | |
| China, Guangdong | |
| Guangzhou, Guangdong, China, 510515 | |
| China, Jiangsu | |
| Suzhou, Jiangsu, China, 215006 | |
| China | |
| Beijing, China, 100730 | |
| Shanghai, China, 200025 | |
| Tianjin, China | |
| Colombia | |
| Bogotá, Distrito Capital de Bogotá, Colombia | |
| Bucaramanga, Santander, Colombia | |
| Czech Republic | |
| Olomouc, Czech Republic, 77520 | |
| India | |
| Hyderabad, India, 500034 | |
| Indonesia | |
| Jakarta, Indonesia, 10430 | |
| Japan | |
| Nishinomiya, Hyogo, Japan, 663-8501 | |
| Kashihara, Nara, Japan, 634-8522 | |
| Shinjuku-ku, Tokyo, Japan, 160-0023 | |
| Suginami, Tokyo, Japan, 167-0035 | |
| Hiroshima, Japan, 734-8551 | |
| Mexico | |
| Guadalajara, Jalisco, Mexico, 44280 | |
| San Luis Potosí, Mexico, 78200 | |
| Romania | |
| Timisoara, Timis, Romania, 300011 | |
| Baia Mare, Romania, 430031 | |
| Bucharest, Romania, 11026 | |
| Bucharest, Romania, 022328 | |
| Russian Federation | |
| Barnaul, Russian Federation, 656050 | |
| Ekaterinburg, Russian Federation, 620149 | |
| Khabarovsk, Russian Federation, 680009 | |
| St. Petersburg, Russian Federation, 191186 | |
| Serbia | |
| Beograd, Serbia, 11000 | |
| Kragujevac, Serbia, 34000 | |
| Nis, Serbia, 18000 | |
| Novi Sad, Serbia, 21000 | |
| Slovakia | |
| Bratislava, Slovakia, 851 07 | |
| South Africa | |
| Johannesburg, Gauteng, South Africa, 2132 | |
| Pretoria, Gauteng, South Africa, 0001 | |
| Taiwan | |
| Taichung, Taiwan, 40447 | |
| Taipei, Taiwan, 11217 | |
| Thailand | |
| Bangkok, Thailand, 10700 | |
| Bangkok, Thailand, 10400 | |
| Turkey | |
| Adana, Turkey, 01330 | |
| Antalya, Turkey, 07059 | |
| Izmir, Turkey, 35-100 | |
| Ukraine | |
| Kiev, Ukraine | |
| Lviv, Ukraine, 79044 | |
| Simferopol, Ukraine, 95023 | |
Sponsors and Collaborators
Bayer
Investigators
| Study Director: | Bayer Study Director | Bayer |
More Information
Additional Information:
No publications provided
| Responsible Party: | Therapeutic Area Head, Bayer Healthcare AG |
| ClinicalTrials.gov Identifier: | NCT01233258 History of Changes |
| Other Study ID Numbers: | 14319, 2009-012150-20 |
| Study First Received: | November 2, 2010 |
| Last Updated: | January 25, 2013 |
| Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica China: Food and Drug Administration Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y Alimentos Czech Republic: State Institute for Drug Control Japan: Pharmaceuticals and Medical Devices Agency Mexico: Federal Commission for Protection Against Health Risks Romania: National Medicines Agency Russia: Ministry of Health of the Russian Federation Serbia and Montenegro: Agency for Drugs and Medicinal Devices Slovakia: State Institute for Drug Control South Africa: Medicines Control Council Taiwan : Food and Drug Administration Turkey: Ministry of Health Ukraine: State Pharmacological Center - Ministry of Health United States: Food and Drug Administration |
Keywords provided by Bayer:
|
Haemophilia treatment rFVIII |
Additional relevant MeSH terms:
|
Hemophilia A Blood Coagulation Disorders, Inherited Blood Coagulation Disorders Hematologic Diseases Coagulation Protein Disorders Hemorrhagic Disorders |
Genetic Diseases, Inborn Factor VIII Coagulants Hematologic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013