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BAX 855 Dose-Escalation Safety Study

Sponsor
Baxalta now part of Shire (Industry)
Overall Status
Completed
CT.gov ID
NCT01599819
Collaborator
Baxter Innovations GmbH (Industry)
19
Enrollment
8
Locations
2
Arms
9.9
Actual Duration (Months)
2.4
Patients Per Site
0.2
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
  • Biological: PEGylated Recombinant Factor VIII
 Phase 1

Study Design

Study Type:
Interventional
Actual Enrollment :
19 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
BAX 855 (PEGylated Recombinant Factor VIII): A Phase 1, Prospective, Open Label, Cross-Over, Dose-Escalation Study in Previously Treated Patients (PTPs) With Severe (FVIII < 1%) Hemophilia A
Actual Study Start Date :
Sep 30, 2011
Actual Primary Completion Date :
Jul 27, 2012
Actual Study Completion Date :
Jul 27, 2012

Arms and Interventions

Arm Intervention/Treatment
Experimental: Cohort 1

Low dose of ADVATE followed by low dose of BAX 855

Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)
Other Names:
  • ADVATE

    • Biological: PEGylated Recombinant Factor VIII
    1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)
    Other Names:
  • BAX 855

    		•
    Experimental: Cohort 2

    High dose of ADVATE followed by high dose of BAX 855

    Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
    1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)
    Other Names:
  • ADVATE

    • Biological: PEGylated Recombinant Factor VIII
    1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)
    Other Names:
  • BAX 855

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serious and non-serious AEs [4 weeks after infusion with BAX 855 and ADVATE]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Male
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • The subject is male and is 18 to 65 years of age at the time of screening

    • The subject has severe hemophilia A (factor VIII level < 1%)

    • The subject was previously treated with plasma-derived factor VIII (FVIII) concentrates or recombinant FVIII for at least 150 exposure days (EDs)

    Exclusion Criteria:

    • The subject has a detectable FVIII inhibitor at screening, with a titer >= 0.6 BU

    • The subject has a documented history of FVIII inhibitors with a titer >= 0.4 BU at any time prior to screening

    • The subject has a known hypersensitivity towards mouse or hamster proteins or to polyethylene glycol (PEG)

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Specialized Hospital for Active Treatment "Joan Pavel" Sofia Bulgaria 1233
    2 Vivantes Klinikum im Friedrichshain, Hemophilia Care Center for Children and Adults Berlin Germany 10249
    3 UKGM Uniklinikum Giessen & Marburg Giessen Germany 35392
    4 Harrison Clinical Research Deutschland Munich Germany 80636
    5 Nara Medical University Hospital Nara Japan 630-8521
    6 Tokyo Medical University Hospital Tokyo Japan 160-0023
    7 Quintiles Drug Research Unit at Guy´s Hospital London United Kingdom SE1 1YR
    8 Manchester Haemophilia Comprehensive Care Centre, Manchester Royal Infirmary Manchester United Kingdom M13 9WL

    Sponsors and Collaborators

    • Baxalta now part of Shire
    • Baxter Innovations GmbH

    Investigators

    • Study Director: Study Director, Takeda

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Baxalta now part of Shire
    ClinicalTrials.gov Identifier:
    NCT01599819
    Other Study ID Numbers:
    • 261101
    • 2011-002011-28
    First Posted:
    May 16, 2012
    Last Update Posted:
    May 5, 2021
    Last Verified:
    Apr 1, 2021
    Additional relevant MeSH terms:
    Hemophilia A
    Factor VIII
    BAX 855

    Study Results

    No Results Posted as of May 5, 2021