A Study to Compare the Pharmacokinetics and Safety of Optivate® and Haemate P® in Patients With Von Willebrand Disease.

NCT ID: NCT02250508

Last Updated: 2018-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2004-12-31

Brief Summary

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The main objectives of the study were

* to compare the pharmacokinetics (PK) of Optivate® and Haemate P® in various types of vonWillebrand disease (VWD) using the results from the VWF: RCo, VWF:Ag, VWF:CBA and Factor VIII assays.
* to compare the clinical tolerance and safety of these two treatments after single IV infusions in subjects with VWD.

Detailed Description

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Conditions

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vonWillebrand's Disease

Study Design

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Primary Study Purpose

TREATMENT

Study Groups

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Optivate®

Group Type EXPERIMENTAL

Optivate® (Human Coagulation Factor VIII)

Intervention Type BIOLOGICAL

Haemate P®

Group Type ACTIVE_COMPARATOR

Haemate P® (Human Coagulation Factor VIII)

Intervention Type BIOLOGICAL

Interventions

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Optivate® (Human Coagulation Factor VIII)

Intervention Type BIOLOGICAL

Haemate P® (Human Coagulation Factor VIII)

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Previously treated subjects of at least 12 years of age, with any type of VWD were eligible for entry into this study.

Exclusion Criteria

\-
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bio Products Laboratory

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Hematology Dept., Sackler School of Medicine, Tel Aviv University

Tel Aviv, , Israel

Site Status

Countries

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Israel

Related Links

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Other Identifiers

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8VWF04

Identifier Type: -

Identifier Source: org_study_id

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