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BAX 855 Dose-Escalation Safety Study

NCT01599819 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 19

Last updated 2021-05-05

No results posted yet for this study

Summary

The objectives of this study are to assess the tolerability and safety after single dose treatments of BAX 855 in previously treated patients (PTPs) with severe hemophilia A, to determine the pharmacokinetic (PK) parameters of BAX 855 compared in crossover with ADVATE, and to evaluate the impact of anti-polyethylene glycol (PEG) antibodies on PK parameters.

Conditions

Interventions

BIOLOGICAL

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method

1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)

BIOLOGICAL

PEGylated Recombinant Factor VIII

1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)

Sponsors & Collaborators

  • Baxter Innovations GmbH

    collaborator INDUSTRY

  • Baxalta now part of Shire

    lead INDUSTRY

Principal Investigators

  • Study Director · Takeda

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

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

Timeline & Regulatory

Start
2011-09-30
Primary Completion
2012-07-27
Completion
2012-07-27

Countries

  • Bulgaria
  • Germany
  • Japan
  • 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 NCT01599819 on ClinicalTrials.gov