Extension Study of Biostate in Subjects With Von Willebrand Disease

Von Willebrand Disease Clinical Trial

Official title:

An Open-Label, Multi-Centre Extension Study to Assess the Efficacy and Safety of Biostate® in Paediatric, Adolescent, and Adult Subjects With Von Willebrand Disease Who Completed Clinical Studies CSLCT-BIO-08-52 or CSLCTBIO-08-54

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01224808
• Other study ID #: CSLCT-BIO-09-64
• Secondary ID: 2009-017301-1114
• Status: Completed
• Phase: Phase 3
• First received: June 8, 2010
• Last updated: October 2, 2017
• Start date: October 2010
• Est. completion date: March 2014

Study information

• Verified date: October 2017
• Source: CSL Behring
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: March 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

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.

Related Conditions & MeSH terms

• Von Willebrand Disease
• Von Willebrand Diseases

Intervention

Biological:
• Biostate
Single bolus doses, administered intravenously. Frequency and dose will be determined by the Investigator based on the subjects clinical condition, previous VWF concentrate requirements, response to therapy, weight and reason for usage.

Locations

Country	Name	City	State
Bulgaria	Study Site	Sofia
Germany	Study Site	Bremen
Poland	Study Site	Warsaw
Poland	Study Site	Wroclaw
Russian Federation	Study Site	Barnaul
Ukraine	Study Site	Lviv

Sponsors (1)

Lead Sponsor	Collaborator
CSL Behring

Countries where clinical trial is conducted

Bulgaria,  Germany,  Poland,  Russian Federation,  Ukraine, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Haemostatic efficacy		Up to 32 months
Secondary	Development of FVIII inhibitors		Up to 32 months
Secondary	Development of VWF inhibitors		Up to 32 months
Secondary	Frequency of Adverse events (AEs) per subject		32 months
Secondary	Severity of AEs per subject		32 months
Secondary	Severity of AEs per infusion		32 months
Secondary	Causality of AEs per subject		32 months
Secondary	Causality of AEs per infusion		32 months
Secondary	Frequency of Adverse events (AEs) per infusion		32 months

External Links

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