NCT00666406

Brief Summary

The purpose of this study is to compare the pharmacokinetic parameters and safety of Advate rAHF-PFM versus Recombinate rAHF in well described previously treated patients with severe hemophilia A (factor VIII level \< 1%).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Mar 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

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

March 31, 2008

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

April 22, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 24, 2008

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 18, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 18, 2009

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

March 26, 2013

Completed
Last Updated

May 19, 2021

Status Verified

April 1, 2021

Enrollment Period

11 months

First QC Date

April 22, 2008

Results QC Date

February 13, 2013

Last Update Submit

April 28, 2021

Conditions

Hemophilia A

Outcome Measures

Primary Outcomes (4)

  • Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. One-Stage Activated Partial Thromboplastin Time (aPTT) -Based Assay Performed at Central Laboratory (Medical University Vienna)

    AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.

    0-30 minutes before infusion up to 48 hours post-infusion

  • Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)

    AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.

    0-30 minutes before infusion up to 48 hours post-infusion

  • Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)

    AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.

    0-30 minutes before infusion up to 48 hours post-infusion

  • Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to 48 Hours. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)

    AUC estimated by linear trapezoidal method. The linear trapezoidal method is a numerical method used to approximate the area under a curve.

    0-30 minutes before infusion up to 48 hours post-infusion

Secondary Outcomes (32)

  • Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)

    0-30 minutes before infusion up to 48 hours post-infusion

  • Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. Chromogenic Assay Performed at Local Laboratory (i.e., University of Bonn, the Study Site)

    0-30 minutes before infusion up to 48 hours post-infusion

  • Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII One-Stage Clotting Assay (Bonn Method) Performed at Local Laboratory (i.e., University of Bonn, the Study Site)

    0-30 minutes before infusion up to 48 hours post-infusion

  • Area Under the Plasma Concentration Versus Time Curve (AUC) From 0 to Infinity. FVIII Clotting Assay. Performed at Local Laboratory (i.e., University of Bonn, the Study Site)

    0-30 minutes before infusion up to 48 hours post-infusion

  • Systemic Clearance (Cl). One-Stage aPTT-Based Assay Performed at Central Laboratory (Medical University Vienna)

    0-30 minutes before infusion up to 48 hours post-infusion

  • +27 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

Advate rAHF-PFM

Drug: Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM)

2

ACTIVE COMPARATOR

Recombinate rAHF

Drug: Recombinant Factor VIII (rAHF)

Interventions

Antihemophilic Factor (Recombinant) - Plasma/Albumin Free Method (rAHF-PFM)DRUG

Infusion of 50 +/- 5 IU/kg bodyweight

Also known as: Advate rAHF-PFM, Recombinant Protein-Free Factor VIII (rAHF-PFM)
1
Recombinant Factor VIII (rAHF)DRUG

Infusion of 50 +/- 5 IU/kg bodyweight

Also known as: Recombinate rAHF, Antihemophilic Factor (Recombinant)
2

Eligibility Criteria

Age15 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Signed informed consent obtained from participant or legally authorized representative
  • years old
  • Factor VIII level \< 1% as documented by previously measured factor VIII and genotyping
  • Previously treated with factor VIII concentrate(s) for a minimum of at least 150 exposure days (as documented by the study site investigator) prior to study entry
  • Observed decrease of efficacy by subject and/or treating physician after being switched from Recombinate rAHF to Advate rAHF-PFM

You may not qualify if:

  • The participant has a detectable factor VIII inhibitor at screening, with a titer \>= 0.4 Bethesda Unit (BU) (Nijmegen modification of the Bethesda Assay) measured at the local and the central laboratory
  • The participant has a known hypersensitivity to mouse or hamster proteins
  • The participant is participating in another investigational drug study within 30 days prior to screening
  • The participant is identified by the investigator as being unable or unwilling to cooperate with study procedures

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Bonn, 53127, Germany

Location

MeSH Terms

Conditions

Hemophilia A

Interventions

Factor VIII

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

Results Point of Contact

Title
Study Director
Organization
Shire
ClinicalTransparency@shire.com
+1 866 842 5335

Study Officials

  • Study Director

    Takeda

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2008

First Posted

April 24, 2008

Study Start

March 31, 2008

Primary Completion

February 18, 2009

Study Completion

February 18, 2009

Last Updated

May 19, 2021

Results First Posted

March 26, 2013

Record last verified: 2021-04

Locations

DE(1)