Extension Study of Biostate in Subjects With Von Willebrand Disease

NCT ID: NCT01224808

Last Updated: 2017-10-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-10-31
• Study Completion Date: 2014-03-31

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.

Conditions

Von Willebrand Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental

Group Type: EXPERIMENTAL

Biostate

Intervention Type: BIOLOGICAL

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.

Interventions

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.

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CSL Behring

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Program Director, Clinical R&D

Role: STUDY_DIRECTOR

CSL Behring

Locations

Study Site

Sofia, , Bulgaria

Study Site

Bremen, , Germany

Study Site

Warsaw, , Poland

Study Site

Wroclaw, , Poland

Study Site

Barnaul, , Russia

Study Site

Lviv, , Ukraine

Countries

Bulgaria; Germany; Poland; Russia; Ukraine

Other Identifiers

2009-017301-11

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1498

Identifier Type: OTHER

Identifier Source: secondary_id

CSLCT-BIO-09-64

Identifier Type: -

Identifier Source: org_study_id