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BAX 855 Dose-Escalation Safety Study

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ClinicalTrials.gov Identifier: NCT01599819
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : October 23, 2017
Sponsor:
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Shire ( Baxalta now part of Shire )

Tracking Information
First Submitted Date  ICMJE May 15, 2012
First Posted Date  ICMJE May 16, 2012
Last Update Posted Date October 23, 2017
Study Start Date  ICMJE September 2011
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 15, 2012)
Serious and non-serious AEs [ Time Frame: 4 weeks after infusion with BAX 855 and ADVATE ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01599819 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE BAX 855 Dose-Escalation Safety Study
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemophilia A
Intervention  ICMJE
  • Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
    1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)
    Other Name: ADVATE
  • Biological: PEGylated Recombinant Factor VIII
    1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)
    Other Name: BAX 855
Study Arms  ICMJE
  • Experimental: Cohort 1
    Low dose of ADVATE followed by low dose of BAX 855
    Interventions:
    • Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
    • Biological: PEGylated Recombinant Factor VIII
  • Experimental: Cohort 2
    High dose of ADVATE followed by high dose of BAX 855
    Interventions:
    • Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
    • Biological: PEGylated Recombinant Factor VIII
Publications * Konkle BA, Stasyshyn O, Chowdary P, Bevan DH, Mant T, Shima M, Engl W, Dyck-Jones J, Fuerlinger M, Patrone L, Ewenstein B, Abbuehl B. Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A. Blood. 2015 Aug 27;126(9):1078-85. doi: 10.1182/blood-2015-03-630897. Epub 2015 Jul 8.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 28, 2012)
19
Original Estimated Enrollment  ICMJE
 (submitted: May 15, 2012)
18
Actual Study Completion Date  ICMJE August 2012
Actual Primary Completion Date August 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Bulgaria,   Germany,   Japan,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01599819
Other Study ID Numbers  ICMJE 261101
2011-002011-28 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Shire ( Baxalta now part of Shire )
Study Sponsor  ICMJE Baxalta now part of Shire
Collaborators  ICMJE Baxter Innovations GmbH
Investigators  ICMJE
Study Director: BioScience Investigator, MD Baxter Healthcare Corporation
PRS Account Shire
Verification Date September 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP