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BAX 855 PK-guided Dosing

NCT02585960 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 135

Last updated 2021-05-25

Study results available
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Summary

1. To compare the efficacy and safety of pharmacokinetic (PK)-guided treatment with BAX 855 targeting FVIII trough levels of 1-3% and approximately 10% (8-12%)
2. To further characterize pharmacokinetic (PK) and pharmacodynamic (PD) parameters of BAX 855

Conditions

Interventions

BIOLOGICAL

PEGylated Recombinant Factor VIII

Pharmacokinetic (PK) evaluation

BIOLOGICAL

PEGylated Recombinant Factor VIII

Standard treatment

BIOLOGICAL

PEGylated Recombinant Factor VIII

Intensified treatment

Sponsors & Collaborators

  • Baxalta Innovations GmbH, now part of Shire

    collaborator INDUSTRY

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-23
Primary Completion
2018-08-05
Completion
2018-08-05

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • France
  • Germany
  • Hong Kong
  • Hungary
  • Israel
  • Italy
  • Malaysia
  • Norway
  • Poland
  • Romania
  • Singapore
  • Spain
  • Sweden
  • Switzerland
  • 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 NCT02585960 on ClinicalTrials.gov