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BAX 855 Continuation

NCT01945593 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 218

Last updated 2021-05-24

Study results available
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Summary

To continue the evaluation of the safety and efficacy of BAX 855 for prophylaxis and treatment of bleeding episodes in adult and pediatric previously treated patients (PTPs) aged ≤ 75 years of age with severe hemophilia A.

Conditions

Interventions

BIOLOGICAL

BAX855

Antihemophilic Factor (Recombinant), PEGylated

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
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-15
Primary Completion
2018-03-02
Completion
2018-03-02
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Czechia
  • Germany
  • Hong Kong
  • Israel
  • Japan
  • Lithuania
  • Malaysia
  • Netherlands
  • Poland
  • Romania
  • Russia
  • South Korea
  • 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 NCT01945593 on ClinicalTrials.gov