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Terminated NCT00555555

Efficacy of Alphanate FVIII/VWF Concentrate in Type 3 Von Willebrand Patients

Conditions: Von Willebrand Disease

Sex: All
Ages: 7 Years – N/A
Healthy volunteers: No
Phase: PHASE4
Enrollment: 4
Sponsor: Grifols Biologicals, LLC

Summary

To assess the efficacy of FVIII/VWF Complex (Human), Alphanate® as replacement therapy in preventing excessive bleeding in subjects with congenital Type 3 von Willebrand Disease (VWD) who undergo surgical procedures.

Eligibility Criteria

Inclusion Criteria: 1. Male or female 7 years of age or older 2. The subject has been diagnosed of inherited VWD of Type 3 as determined by subject's medical records. 3. The subject needs a surgical procedure (at least 10 surgical procedures have to be considered as "Major" according to the criteria of the protocol). 4. The subject is expected to respond to exogenously administered FVIII/VWF according to Investigator's judgment. 5. The subject freely gives written informed consent. Subjects who are not legally permitted to provide written consent must sign a form of assent for study participation, and written consent must be provided by a parent or legal guardian. Exclusion Criteria: 1. The subject has been diagnosed of Type 1, Type 2, or acquired VWD. 2. The subject is known to have history of intolerance to any Alphanate® containing substance. 3. The subject is known to have history of anaphylactic reaction(s) to blood or blood components. 4. Liver function tests (AST, ALT, bilirubin) \> 2.5 x upper limit of normal (ULN). 5. Renal function test (creatinine) \> 1.5 x ULN. 6. The subject is known or suspected to have present or past inhibitor activity (antibodies) directed against FVIII or VWF. 7. The subject is known to abuse alcohol or illicit drug use within the past 12 months. 8. The subject is participating in another clinical study involving an investigational treatment, or participated within the past 4 weeks. Studies consisting of data and blood sampling collections on a regular or long-term basis are exempt from this exclusion. 9. The subject is unlikely to adhere to the protocol requirements of the study.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT00555555). StuddyBuddy aggregates publicly available trial information.