BAX 855 Dose-Escalation Safety Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-07-27

Brief Summary

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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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Detailed Description

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Conditions

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Hemophilia A

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cohort 1

Low dose of ADVATE followed by low dose of BAX 855

Group Type EXPERIMENTAL

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method

Intervention Type BIOLOGICAL

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

PEGylated Recombinant Factor VIII

Intervention Type BIOLOGICAL

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

Cohort 2

High dose of ADVATE followed by high dose of BAX 855

Group Type EXPERIMENTAL

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method

Intervention Type BIOLOGICAL

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

PEGylated Recombinant Factor VIII

Intervention Type BIOLOGICAL

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

Interventions

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Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method

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

Intervention Type BIOLOGICAL

PEGylated Recombinant Factor VIII

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

Intervention Type BIOLOGICAL

Other Intervention Names

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ADVATE BAX 855

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No