Extension Study of Biostate in Subjects With Von Willebrand Disease

Phase 3

Completed

• Conditions: Von Willebrand Disease
• Interventions: Biological: Biostate

• Registration Number: NCT01224808
• Lead Sponsor: CSL Behring

Brief Summary

The aim of the Von Willebrand Disease (VWD) therapy is to treat and prevent bleeding episodes due to abnormal platelet adhesion and abnormal blood coagulation as a result of low or abnormal Von Willebrand Factor (VWF) and/or Factor VIII (FVIII) levels. The long-term efficacy and safety of a VWF/FVIII concentrate, Biostate, will be investigated in children, adolescents, and adults with VWD in whom treatment with a VWF product is required for prophylactic therapy, haemostatic control during surgery, or control of a non-surgical, spontaneous, or traumatic bleeding event.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-06-08
• Study Start: 2010-10
• Study First Submitted QC: 2010-10-19
• Study First Posted: 2010-10-20
• Primary Completion: 2014-03
• Study Completion: 2014-03
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-02
• Last Update Posted: 2017-10-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Have completed Study CSLCT-BIO-08-52 (Assessment of Efficacy and Safety of Biostate in Paediatric Subjects with Von Willebrand Disease) or Study CSLCT-BIO-08-54 (Assessment of Efficacy and Safety of Biostate in Adolescent or Adult Subjects with Von Willebrand Disease).
• The subject and/or his/her legal guardian understand(s) the nature of the study and has/have given written informed consent to participate in the study and is/are willing to comply with the protocol.

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Exclusion Criteria

• Early discontinuation of a subject from the main studies CSLCT-BIO-08-52 or CSLCT-BIO-08-54.
• Mental condition rendering the subject (or the subject's legal guardian) unable to understand the nature, scope and possible consequences of the study.
• Any condition that is likely to interfere with evaluation of the IMP or satisfactory conduct of the study.
• Are not willing and/or not able to comply with the study requirements.
• Employee at the study site, or spouse/partner or relative of the Investigator or Subinvestigators.
• Female subjects of childbearing potential either not using, or not willing to use, a medically reliable method of contraception for the entire duration of the study, or not sexually abstinent for the entire duration of the study, or not surgically sterile.
• Intention to become pregnant during the course of the study.
• Pregnancy, or nursing mother.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental	Biostate	-

Primary Outcome Measures

Name	Time	Method
Haemostatic efficacy	Up to 32 months

Secondary Outcome Measures

Name	Time	Method
Severity of AEs per infusion	32 months
Frequency of Adverse events (AEs) per subject	32 months
Development of VWF inhibitors	Up to 32 months
Severity of AEs per subject	32 months
Causality of AEs per subject	32 months
Causality of AEs per infusion	32 months
Development of FVIII inhibitors	Up to 32 months
Frequency of Adverse events (AEs) per infusion	32 months

Trial Locations

Locations (1)

Study Site; 🇺🇦 Lviv, Ukraine