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NCT01599819 Clinical Trial

BAX 855 Dose-Escalation Safety Study

Hemophilia A Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01599819
Other study ID # 261101
Secondary ID 2011-002011-28
Status Completed
Phase Phase 1
First received
Last updated
Start date September 30, 2011
Est. completion date July 27, 2012

Study information
Verified date April 2021
Source Takeda
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 19
Est. completion date July 27, 2012
Est. primary completion date July 27, 2012
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 65 Years
Eligibility 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)

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method
1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)
• PEGylated Recombinant Factor VIII
1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)

Locations
Country Name City State
Bulgaria Specialized Hospital for Active Treatment "Joan Pavel" Sofia
Germany Vivantes Klinikum im Friedrichshain, Hemophilia Care Center for Children and Adults Berlin
Germany UKGM Uniklinikum Giessen & Marburg Giessen
Germany Harrison Clinical Research Deutschland Munich
Japan Nara Medical University Hospital Nara
Japan Tokyo Medical University Hospital Tokyo
United Kingdom Quintiles Drug Research Unit at Guy´s Hospital London
United Kingdom Manchester Haemophilia Comprehensive Care Centre, Manchester Royal Infirmary Manchester

Sponsors (2)
Lead Sponsor Collaborator
Baxalta now part of Shire Baxter Innovations GmbH

Countries where clinical trial is conducted

Bulgaria,  Germany,  Japan,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary Serious and non-serious AEs 4 weeks after infusion with BAX 855 and ADVATE
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