Active — Not RecruitingPhase 4

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

15 participantsStarted 2007-09

Plain-language 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.

Who can participate

Age range7 Years

SexALL

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Inclusion criteria

✓. Male or female 7 years of age or older
✓. The subject has been diagnosed of inherited VWD of Type 3 as determined by subject's medical records.
✓. The subject needs a surgical procedure (at least 10 surgical procedures have to be considered as "Major" according to the criteria of the protocol).
✓. The subject is expected to respond to exogenously administered FVIII/VWF according to Investigator's judgment.
✓. The subject freely gives written informed consent. Patients 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

✕. The subject has been diagnosed of acquired VWD.
✕. The subject is known to have history of intolerance to any Alphanate® containing substance.
✕. The subject is known to have history of anaphylactic reaction(s) to blood or blood components.
✕. Liver function tests (AST, ALT, bilirubin) \> 2.5 x upper limit of normal (ULN).
✕. Renal function test (creatinine, BUN) \> 1.5 x ULN.
✕. The subject is known or suspected to have present or past inhibitor activity (antibodies) directed against FVIII or VWF.
✕. The subject is known to abuse alcohol or illicit drug use within the past 12 months.
✕. The subject is participating in another clinical study involving an investigational treatment, or participated within the past 4 weeks (except if the patient is participating in another Alphanate® study). Studies consisting of data and blood sampling collections on a regular or long-term basis are exempt from this exclusion.

What they're measuring

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 (mostly major surgeries).

Timeframe: 30 days

Trial details

NCT IDNCT00555555

SponsorGrifols Biologicals, LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-12

View on ClinicalTrials.gov More Von Willebrand Disease trials