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

NCT00555555 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 15

Last updated 2023-08-25

No results posted yet for this study

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.

Conditions

  • Von Willebrand Disease

Interventions

BIOLOGICAL

Alphanate SD/HT

A general guideline based on the product Full Prescribing Information is recommended with a maximum dose of 80 VWF:RCof IU/kg. The number of administrations before, during, and after the surgery procedure depends on the subject's clinical condition and the type of surgery itself. Single administrations or multiple doses may be appropriate. The dose of Alphanate® administered to each subject will be recorded as IU of VWF:RCof and also as IU of FVIII:C. The lot number for each vial of concentrate administered will also be recorded.

Sponsors & Collaborators

  • Grifols Biologicals, LLC

    lead INDUSTRY

Principal Investigators

  • Paul J Pinciaro, PhD · Grifols Biologicals, LLC

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
7 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-09-30
Primary Completion
2028-12-31
Completion
2029-03-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00555555 on ClinicalTrials.gov