BAX 855 Dose-Escalation Safety Study

Phase 1

Completed

• Conditions: Hemophilia A
• Interventions: Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method; Biological: PEGylated Recombinant Factor VIII

• Registration Number: NCT01599819
• Lead Sponsor: Baxalta now part of Shire

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 available

Study Timeline

• Study Start: 2011-09-30
• Study First Submitted: 2012-05-15
• Study First Submitted QC: 2012-05-15
• Study First Posted: 2012-05-16
• Primary Completion: 2012-07-27
• Study Completion: 2012-07-27
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-30
• Last Update Posted: 2021-05-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 19

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cohort 2	Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method	High dose of ADVATE followed by high dose of BAX 855
Cohort 2	PEGylated Recombinant Factor VIII	High dose of ADVATE followed by high dose of BAX 855
Cohort 1	PEGylated Recombinant Factor VIII	Low dose of ADVATE followed by low dose of BAX 855
Cohort 1	Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method	Low dose of ADVATE followed by low dose of BAX 855

Primary Outcome Measures

Name	Time	Method
Serious and non-serious AEs	4 weeks after infusion with BAX 855 and ADVATE

Trial Locations

Locations (8)

Harrison Clinical Research Deutschland; 🇩🇪 Munich, Germany

Specialized Hospital for Active Treatment "Joan Pavel"; 🇧🇬 Sofia, Bulgaria

UKGM Uniklinikum Giessen & Marburg; 🇩🇪 Giessen, Germany

Nara Medical University Hospital; 🇯🇵 Nara, Japan

Vivantes Klinikum im Friedrichshain, Hemophilia Care Center for Children and Adults; 🇩🇪 Berlin, Germany

Quintiles Drug Research Unit at Guy´s Hospital; 🇬🇧 London, United Kingdom

Tokyo Medical University Hospital; 🇯🇵 Tokyo, Japan

Manchester Haemophilia Comprehensive Care Centre, Manchester Royal Infirmary; 🇬🇧 Manchester, United Kingdom