Clinical trial: Extension Study of Biostate in Subjects With Von Willebrand Disease (NCT01224808)

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.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.



Patient description (medical language): A 23-year-old female has prolonged oral bleeding immediately after a tooth extraction.  Despite several interventions, the bleeding persists for hours and stops only after desmopressin (DDAVP) administration.  The patient has heavy menstrual cycles each month.  She has no other medical problems and takes no medications.  Her mother and grandmother have also had excessive bleeding during menstrual period.  Review of systems is positive for mild bruising on his legs. Laboratory findings reveal a normal platelet count and an abnormal ristocetin cofactor assay, as well as CB <= 0.30 IU/mL and FVIII:C <= 0.40 IU/mL.

Patient description (patient's own words): I'm a 23 woman and I went to the ER because of non-stop bleeding after my tooth extraction. I tried to make the bleeding stop but it just kept going for hours and it finally stopped when I took some medication called DDAVP. I usually have heavy periods, just like my mom and grandma had. I don't have any other medical condition and I don't take any other medication. The doctor noticed the bruises on my legs. I had to do some lab tests. I had a normal platelet count but an abnormal ristocetin cofactor assay. I had low CB and FVIII:C levels.

Does the patient match the trial criteria? Entailment