NCT01599819

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Sep 2011

Geographic Reach
4 countries

8 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 30, 2011

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 15, 2012

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 16, 2012

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 27, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 27, 2012

Completed
Last Updated

May 5, 2021

Status Verified

April 1, 2021

Enrollment Period

10 months

First QC Date

May 15, 2012

Last Update Submit

April 30, 2021

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (1)

  • Serious and non-serious AEs

    4 weeks after infusion with BAX 855 and ADVATE

Study Arms (2)

Cohort 1

EXPERIMENTAL

Low dose of ADVATE followed by low dose of BAX 855

Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free MethodBiological: PEGylated Recombinant Factor VIII

Cohort 2

EXPERIMENTAL

High dose of ADVATE followed by high dose of BAX 855

Biological: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free MethodBiological: PEGylated Recombinant Factor VIII

Interventions

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free MethodBIOLOGICAL

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

Also known as: ADVATE
Cohort 1Cohort 2
PEGylated Recombinant Factor VIIIBIOLOGICAL

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

Also known as: BAX 855
Cohort 1Cohort 2

Eligibility Criteria

Age18 Years - 65 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Specialized Hospital for Active Treatment "Joan Pavel"

Sofia, 1233, Bulgaria

Location

Vivantes Klinikum im Friedrichshain, Hemophilia Care Center for Children and Adults

Berlin, 10249, Germany

Location

UKGM Uniklinikum Giessen & Marburg

Giessen, 35392, Germany

Location

Harrison Clinical Research Deutschland

Munich, 80636, Germany

Location

Nara Medical University Hospital

Nara, 630-8521, Japan

Location

Tokyo Medical University Hospital

Tokyo, 160-0023, Japan

Location

Quintiles Drug Research Unit at Guy´s Hospital

London, SE1 1YR, United Kingdom

Location

Manchester Haemophilia Comprehensive Care Centre, Manchester Royal Infirmary

Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

  • Konkle BA, Stasyshyn O, Chowdary P, Bevan DH, Mant T, Shima M, Engl W, Dyck-Jones J, Fuerlinger M, Patrone L, Ewenstein B, Abbuehl B. Pegylated, full-length, recombinant factor VIII for prophylactic and on-demand treatment of severe hemophilia A. Blood. 2015 Aug 27;126(9):1078-85. doi: 10.1182/blood-2015-03-630897. Epub 2015 Jul 8.

    PMID: 26157075DERIVED

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIIIBAX 855

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Blood Coagulation FactorsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsProtein PrecursorsBiological Factors

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 15, 2012

First Posted

May 16, 2012

Study Start

September 30, 2011

Primary Completion

July 27, 2012

Study Completion

July 27, 2012

Last Updated

May 5, 2021

Record last verified: 2021-04

Locations

BU(1)DE(3)JP(2)GB(2)