Wilate in Subjects With Von Willebrand Disease Who Undergo Surgery

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-06-30

Study Completion Date

2014-04-30

Brief Summary

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Proportion of surgeries in which the primary endpoint (overall assessment) is classified as success.

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Detailed Description

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Conditions

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Prevent Bleeding in Major Surgery

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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human VWF/FVIII concentrate

Group Type EXPERIMENTAL

human VWF/FVIII concentrate

Intervention Type BIOLOGICAL

intravenous infusion. Dose based on subject's individual invivo-recovery

Interventions

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human VWF/FVIII concentrate

intravenous infusion. Dose based on subject's individual invivo-recovery

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Diagnosed with congenital VWD (von Willebrand Disease)
* Require therapy with a VWF (von Willebrand Factor) product to treat any major surgical procedure

Exclusion Criteria

* Known coagulation disorder other than VWD
* Known history of, or suspected VWF or FVIII inhibitors
* Subjects with hepatic liver disease
* Known or suspected hypersensitivity or previous evidence of severe side effects to wilate or other VWF/FVIII concentrates
* Pregnant women in the first 20 weeks of gestation

Minimum Eligible Age

6 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No