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Completed

NCT Number: NCT01599819

BAX 855 Dose-Escalation Safety Study

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.

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Key information

Conditions

Hemophilia A Blood Coagulation Disorders Blood Coagulation Disorders, Inherited Coagulation Protein Disorders Congenital, Hereditary, and Neonatal Diseases and Abnormalities Genetic Diseases, Inborn Hematologic Diseases Hemic and Lymphatic Diseases Hemorrhagic Disorders

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Specialized Hospital for Active Treatment "Joan Pavel", Sofia, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method

Biological

1 PK infusion of ADVATE (low dose in Cohort 1, high dose in Cohort 2)

Other names: ADVATE

PEGylated Recombinant Factor VIII

Biological

1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)

Other names: BAX 855

Primary outcomes

  1. Serious and non-serious AEs

    Time frame: 4 weeks after infusion with BAX 855 and ADVATE

Sponsors and collaborators

Lead sponsor

Baxalta now part of Shire

Industry

Collaborators

  • Baxter Innovations GmbH

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
May 16, 2012
Registry last updated
May 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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