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Clinical Study to Investigate the Efficacy and Safety of Wilate During Prophylaxis in Previously Treated Patients With VWD

NCT04052698 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2023-10-25

Study results available
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Summary

This is a prospective, non-controlled, international, multi-center phase 3 study investigating the efficacy and safety of Wilate in previously treated adult patients with VWD, to obtain additional data on the safety and efficacy of Wilate in previously treated patients with VWD undergoing regular prophylaxis.

Conditions

  • Von Willebrand Diseases

Interventions

DRUG

Wilate

Produced from the plasma of human donors, Wilate is presented as a powder or solvent for intravenous injection containing normally 500 IU or 1000 IU human VWF and human FVIII per vial. The ratio between VWF ristocetin co-factor activity (VWF:RCo) and FVIII:C is 1:1. The product contains approximately 100 IU/ml human VWF when reconstituted with 5ml/10mL water for injection with 0.1% polysorbate 80. The specific activity of Wilate is ≥67 IU VWF:RCo/mg protein. The injection or infusion rate should not exceed 2-3mL per minute.

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Cristina Solomon · Octapharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-06-18
Primary Completion
2022-04-23
Completion
2022-04-23
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Bulgaria
  • Croatia
  • Hungary
  • Lebanon
  • Russia
  • Ukraine

Study Locations

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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 NCT04052698 on ClinicalTrials.gov