NL-OMON38008
Recruiting
Phase 3
A Phase 3 clinical study to determine the pharmacokinetics, safety and efficacy of rVWF:rFVIII and rVWF in the treatment of bleeding episodes in subjects diagnosed with von Willebrand disease - Baxter 071001
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Coagulation disorder
- Sponsor
- Baxter
- Enrollment
- 4
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The subject has been diagnosed with:
- •Type 1 (VWF:RCo \< 20 IU/dL) or,
- •Type 2A (VWF:RCo\< 20 IU/dL), Type 2B (as diagnosed by genotype), Type 2N
- •(FVIII:C\<10% and historically documented genetics), Type 2M or,
- •Type 3 (VWF:Ag \<\= 3 IU/dL) or,
- •Severe VWD with a history of requiring substitution therapy with von Willebrand factor
- •concentrate to control bleeding
- •The subject, who participates for the treatment for bleeding episodes, has had a minimum of 1 documented bleeds (medical history) requiring VWF coagulation factor replacement therapy during the previous 12 months prior to enrollment.
- •The subject has a Karnofsky score \>\=60\.
- •The subject is at least 18 and not older than 65 years of age at enrollment.
Exclusion Criteria
- •The subject has been diagnosed with pseudo VWD or another hereditary or acquired coagulation
- •disorder other than VWD (eg qualitative and quantitative platelet disorders or elevated PT/
- •international normalized ratio \[INR] \>1\.4\).
- •The subject has a documented history of a VWF:RCo half\-life of \<6 hours.
- •The subject has a history or presence of a VWF inhibitor at screening.
- •The subject has a history or presence of a factor VIII (FVIII) inhibitor with a titer \>\=0\.4 BU (by Nijmegen assay) or \>\=0\.6 BU (by Bethesda assay).
- •The subject has a known hypersensitivity to any of the components of the study drugs, such as to
- •mouse or hamster proteins.
- •The subject has a medical history of immunological disorders, excluding seasonal allergic
- •rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies.
Outcomes
Primary Outcomes
Not specified
Similar Trials
Unknown
Phase 3
A clinical trial to determine the distribution through the patientâ??s body, safety and effectiveness of rVWF and rFVIII in treatment of bleeding episodes in patientâ??s diagnosed with the Von Willebrand Disease.CTRI/2012/01/002390Baxter Healthcare Corporation45
Active, not recruiting
Not Applicable
Clinical study to explore the pharmacokinetics, safety and efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.EUCTR2010-024108-84-ITBAXTER INNOVATIONS GMBH40
Active, not recruiting
Not Applicable
Clinical study to explore the influence of the human body on the study drug, on the safety and the efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.EUCTR2010-024108-84-ATBaxter Innovations GmbH49
Active, not recruiting
Not Applicable
Clinical study to explore the influence of the human body on the study drug, on the safety and efficacy of recombinant VWF (in combination with recombinant FVIII and recombinant VWF alone) in the treatment of bleeding episodes in patients with von Willebrand Disease.EUCTR2010-024108-84-DEBaxter Innovations GmbH49
Active, not recruiting
Not Applicable
Clinical study to explore the influence of the human body on the studydrug, on the safety and the efficacy of recombinant VWF (in combinationwith recombinant FVIII and recombinant VWF alone) in the treatment ofbleeding episodes in patients with von Willebrand Disease.EUCTR2010-024108-84-SEBaxter Innovations GmbH49