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Clinical Trials/CTRI/2012/01/002390
CTRI/2012/01/002390
Other
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 Healthcare Corporation0 sites45 target enrollmentTBD
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Overview

Phase
Phase 3
Intervention
Not specified
Conditions
Not specified
Sponsor
Baxter Healthcare Corporation
Enrollment
45
Status
Other
Last Updated
4 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
4 years ago
Study Type
Interventional

Investigators

Eligibility Criteria

Inclusion Criteria

  • •The subject has been diagnosed with:
  • •o type 3 VWD (VWF:Ag \<\=3 IU/dl) or
  • •o severe non\-type 3 VWD (VWF:RCo \<20 IU/dL) or
  • •o type 2N VWD (FVIII:C \<10% and historically documented genetics)
  • •The 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 previous3 years prior to enrollment.
  • •The subject has a Karnofsky score \>\=60\.
  • •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.

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.
  • •The subject has a medical history of a thromboembolic event.
  • •The subject is HIV positive with an absolute CD4 count \<200/mm3\.
  • •The subject has been diagnosed with cardiovascular disease (New York Heart Association \[NYHA] classes 1\-4\)
  • •The subject has an acute illness (eg, influenza, flu\-like syndrome, allergic rhinitis/conjunctivitis, non\-seasonal asthma) at screening.

Outcomes

Primary Outcomes

Not specified

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