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Completed

NCT Number: NCT01224808

Extension Study of Biostate in Subjects With Von Willebrand Disease

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.

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Key information

Conditions

Von Willebrand Disease Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Blood Platelet Disorders Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders von Willebrand Diseases

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Study Site, Sofia, Bulgaria

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biostate

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.

Primary outcomes

  1. Haemostatic efficacy

    Time frame: Up to 32 months

Secondary outcomes

  1. Development of FVIII inhibitors

    Time frame: Up to 32 months

  2. Development of VWF inhibitors

    Time frame: Up to 32 months

  3. Frequency of Adverse events (AEs) per subject

    Time frame: 32 months

  4. Severity of AEs per subject

    Time frame: 32 months

  5. Severity of AEs per infusion

    Time frame: 32 months

  6. Causality of AEs per subject

    Time frame: 32 months

  7. Causality of AEs per infusion

    Time frame: 32 months

  8. Frequency of Adverse events (AEs) per infusion

    Time frame: 32 months

Sponsors and collaborators

Lead sponsor

CSL Behring

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Oct 20, 2010
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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