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Study Investigating a PEGylated Recombinant Factor VIII (BAX 855) for Hemophilia A (PROLONG-ATE Study)

NCT01736475 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 159

Last updated 2021-05-20

Study results available
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Summary

To assess efficacy and safety, including immunogenicity of BAX 855 administered as prophylaxis and as on-demand therapy in adult and adolescent (12-65 years) previously treated patients (PTPs) with severe hemophilia A To determine the pharmacokinetic (PK) parameters of BAX 855.

Conditions

Interventions

BIOLOGICAL

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method

Pharmacokinetic (PK) evaluation of ADVATE

BIOLOGICAL

PEGylated Recombinant Factor VIII

Pharmacokinetic (PK) evaluation of BAX 855

BIOLOGICAL

PEGylated Recombinant Factor VIII

Prophylaxis treatment

BIOLOGICAL

PEGylated Recombinant Factor VIII

On-demand treatment

Sponsors & Collaborators

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2014-07-17
Completion
2014-07-17

Countries

  • United States
  • Australia
  • Austria
  • Bulgaria
  • Czechia
  • Germany
  • Israel
  • Japan
  • Lithuania
  • Malaysia
  • Netherlands
  • Poland
  • Romania
  • South Korea
  • Spain
  • Sweden
  • Switzerland
  • Taiwan
  • 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 NCT01736475 on ClinicalTrials.gov