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Pharmacokinetics, Efficacy, Safety, and Immunogenicity of Wilate in Previously Treated Paediatric Patients With Severe Haemophilia A

NCT03376516 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2021-01-19

Study results available
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Summary

A prospective, non-controlled, international, multi-centre phase 3 study to investigate the pharmacokinetics, efficacy, safety, and immunogenicity of Wilate in previously treated children with severe haemophilia A

Conditions

  • Severe Hemophilia A

Interventions

DRUG

Wilate

von Willebrand factor / Factor VIII (plasma derived)

Sponsors & Collaborators

  • Octapharma

    lead INDUSTRY

Principal Investigators

  • Cristina Solomon, MD · Octapharma

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
1 Year
Max Age
11 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-22
Primary Completion
2018-11-03
Completion
2018-11-03
FDA Drug
Yes

Countries

  • 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 NCT03376516 on ClinicalTrials.gov