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 INNOVATIONS GMBH0 sites40 target enrollmentMarch 1, 2012

DrugsADVATE (rAHF-PFM)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Not specified
Sponsor: BAXTER INNOVATIONS GMBH
Enrollment: 40
Status: Active, not recruiting
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

March 1, 2012

End Date

TBD

Last Updated

11 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

BAXTER INNOVATIONS GMBH

Eligibility Criteria

Inclusion Criteria

•Subject has been diagnosed with: type 3 VWD (VWF: Ag \=3 IU/dl) or severe non\-type 3 VWD (VWF:RCo \<20 IU/dL) or type 2N VWD (FVIII:C\<10% and historically documented genetics) • Subject, who participates for the treatment for bleeding episodes, has had a minimum of 6 documented bleeds (medical history) requiring VWF coagulation factor replacement therapy during the previous 3 years prior to enrollment. • Subject has a Karnofsky score \=60\. • Subject is at least 18 and not older than 65 years of age at enrollment. • If female of childbearing potential, subject presents with a negative pregnancy test • The subject agrees to employ adequate birth control measures for the duration of the study. • Subject is willing and able to comply with the requirements of the protocol.
•Are the trial subjects under 18? no
•Number of subjects for this age range: 0
•F.1\.2 Adults (18\-64 years) yes
•F.1\.2\.1 Number of subjects for this age range 40
•F.1\.3 Elderly (\>\=65 years) no
•F.1\.3\.1 Number of subjects for this age range

Exclusion Criteria

•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\). • Subject has a documented history of a VWF:RCo half\-life of \<6 hours. • Subject has a history or presence of a VWF inhibitor at screening. • 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). • Subject has a known hypersensitivity to any of the components of the study drugs, such as to mouse or hamster proteins. • Subject has a medical history of immunological disorders, excluding seasonal allergic rhinitis/conjunctivitis, mild asthma, food allergies or animal allergies. • Subject has a medical history of a thromboembolic event. • Subject is HIV positive with an absolute CD4 count \<200/mm3\. • Subject has been diagnosed with cardiovascular disease (New York Heart Association \[NYHA] classes 1\-4\). • Subject has an acute illness (eg, influenza, flu\-like syndrome, allergic rhinitis/conjunctivitis, non\-seasonal asthma) at screening. • Subject has been diagnosed with significant liver disease as evidenced by any of the following: serum alanine aminotransferase (ALT) 5 times the upper limit of normal; hypoalbuminemia; portal vein hypertension (eg, presence of otherwise unexplained splenomegaly, history of esophageal varices). • Subject has been diagnosed with renal disease, with a serum creatinine level \=2 mg/dL. • In the judgment of the investigator, the subject has another clinically significant concomitant disease (eg, uncontrolled hypertension) that may pose additional risks for the subject. • Subject has been treated with an immunomodulatory drug, excluding topical treatment (eg,ointments, nasal sprays), within 30 days prior to signing the informed consent. • Subject is pregnant or lactating at the time of enrollment. • Subject has participated in another clinical study involving an IP or investigational device within 30 days prior to enrollment or is scheduled to participate in another clinical study involving an investigational product or investigational device during the course of this study. • Subject has a history of drug or alcohol abuse within the 2 years prior to enrollment. • Subject has a progressive fatal disease and/or life expectancy of less than 3 months. • Subject is identified by the investigator as being unable or unwilling to cooperate with study procedures. • Subject suffers from a mental condition rendering him/her unable to understand the nature, scope and possible consequences of the study and/or evidence of an uncooperative attitude. • Subject is in prison or compulsory detention by regulatory and/or juridical order.