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BAX 855 Pediatric Study

NCT02210091 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 75

Last updated 2021-05-24

Study results available
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Summary

The study purpose is:

* To assess the incidence of FVIII inhibitory antibodies during 6 months of twice weekly prophylactic treatment with BAX 855 or 50 exposure days (EDs), whichever occurs last.
* To compare pharmacokinetic (PK) parameters to ADVATE.
* To assess hemostatic efficacy in prophylaxis and the treatment of bleeding episodes.
* To evaluate safety and immunogenicity.

Conditions

Interventions

BIOLOGICAL

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method

Pharmacokinetic (PK) analysis of ADVATE

BIOLOGICAL

PEGylated Recombinant Factor VIII

Pharmacokinetic (PK) analysis of BAX 855

BIOLOGICAL

PEGylated Recombinant Factor VIII

Prophylaxis treatment

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-10-31
Primary Completion
2015-10-23
Completion
2015-10-23

Countries

  • United States
  • Bulgaria
  • Hong Kong
  • Malaysia
  • Netherlands
  • South Korea
  • Spain
  • Taiwan
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

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 NCT02210091 on ClinicalTrials.gov