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BAX 855 Dose-Escalation Safety Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01599819
Recruitment Status : Completed
First Posted : May 16, 2012
Last Update Posted : May 5, 2021
Sponsor:
Collaborator:
Baxter Innovations GmbH
Information provided by (Responsible Party):
Takeda ( Baxalta now part of Shire )

Study Description
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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
Hemophilia A Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method Biological: PEGylated Recombinant Factor VIII Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : September 30, 2011
Actual Primary Completion Date : July 27, 2012
Actual Study Completion Date : July 27, 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hemophilia

Arms and Interventions
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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 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
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 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


Outcome Measures
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Primary Outcome Measures :
  1. Serious and non-serious AEs [ Time Frame: 4 weeks after infusion with BAX 855 and ADVATE ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01599819


Locations
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Bulgaria
Specialized Hospital for Active Treatment "Joan Pavel"
Sofia, Bulgaria, 1233
Germany
Vivantes Klinikum im Friedrichshain, Hemophilia Care Center for Children and Adults
Berlin, Germany, 10249
UKGM Uniklinikum Giessen & Marburg
Giessen, Germany, 35392
Harrison Clinical Research Deutschland
Munich, Germany, 80636
Japan
Nara Medical University Hospital
Nara, Japan, 630-8521
Tokyo Medical University Hospital
Tokyo, Japan, 160-0023
United Kingdom
Quintiles Drug Research Unit at Guy´s Hospital
London, United Kingdom, SE1 1YR
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
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Study Director: Study Director Takeda
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Baxalta now part of Shire
ClinicalTrials.gov Identifier: NCT01599819    
Other Study ID Numbers: 261101
2011-002011-28 ( EudraCT Number )
First Posted: May 16, 2012    Key Record Dates
Last Update Posted: May 5, 2021
Last Verified: April 2021
Additional relevant MeSH terms:
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Hemophilia A
Blood Coagulation Disorders, Inherited
Blood Coagulation Disorders
Hematologic Diseases
Coagulation Protein Disorders
 Hemorrhagic Disorders
Genetic Diseases, Inborn
Factor VIII
BAX 855
Coagulants