BAX 855 Dose-Escalation Safety Study

April 30, 2021 updated by: Baxalta now part of Shire

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

19

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Sofia, Bulgaria, 1233
        • Specialized Hospital for Active Treatment "Joan Pavel"
  • Germany
      • Berlin, Germany, 10249
        • Vivantes Klinikum im Friedrichshain, Hemophilia Care Center for Children and Adults
      • Giessen, Germany, 35392
        • UKGM Uniklinikum Giessen & Marburg
      • Munich, Germany, 80636
        • Harrison Clinical Research Deutschland
  • Japan
      • Nara, Japan, 630-8521
        • Nara Medical University Hospital
      • Tokyo, Japan, 160-0023
        • Tokyo Medical University Hospital
  • United Kingdom
      • London, United Kingdom, SE1 1YR
        • Quintiles Drug Research Unit at Guy´s Hospital
      • Manchester, United Kingdom, M13 9WL
        • Manchester Haemophilia Comprehensive Care Centre, Manchester Royal Infirmary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: CROSSOVER
  • Masking: NONE

Arms and Interventions

Participant Group / 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 Names:
  • ADVATE
Biological: PEGylated Recombinant Factor VIII
1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)
Other Names:
  • 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 Names:
  • ADVATE
Biological: PEGylated Recombinant Factor VIII
1 PK infusion of BAX 855 (low dose in Cohort 1, high dose in Cohort 2)
Other Names:
  • BAX 855

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Serious and non-serious AEs
Time Frame: 4 weeks after infusion with BAX 855 and ADVATE
4 weeks after infusion with BAX 855 and ADVATE

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxalta now part of Shire

Collaborators

Baxter Innovations GmbH

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

September 30, 2011

Primary Completion (ACTUAL)

July 27, 2012

Study Completion (ACTUAL)

July 27, 2012

Study Registration Dates

First Submitted

May 15, 2012

First Submitted That Met QC Criteria

May 15, 2012

First Posted (ESTIMATE)

May 16, 2012

Study Record Updates

Last Update Posted (ACTUAL)

May 5, 2021

Last Update Submitted That Met QC Criteria

April 30, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 261101
  • 2011-002011-28 (EUDRACT_NUMBER)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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