NCT00749476

Brief Summary

The purpose of this study is to collect data around the period of the conversion from plasma-derived Factor IX (pdFIX) to BeneFIX. The main information collected will be: a retrospective history of the bleedings in the 3-month period before the conversion, the recovery with pdFIX just before the conversion and with BeneFIX just after the conversion, and a prospective history of the bleedings in the 3 month period following the conversion.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
1

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Apr 2008

Shorter than P25 for phase_4

Geographic Reach
1 country

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

April 1, 2008

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 8, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 9, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2009

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

June 29, 2010

Completed
Last Updated

June 8, 2011

Status Verified

June 1, 2011

Enrollment Period

9 months

First QC Date

September 8, 2008

Results QC Date

January 29, 2010

Last Update Submit

June 6, 2011

Conditions

Hemophilia B

Outcome Measures

Primary Outcomes (1)

  • Number of Participants Reporting Efficacy

    Clinical efficacy was measured by number/location of bleeding episodes, number of injections per bleeding, factor IX consumption, global assessment of efficacy by investigator and patient; biological efficacy (recovery) with BeneFIX was measured just after conversion.

    4 months

Study Arms (1)

1

EXPERIMENTAL
Biological: Factor IX recovery

Interventions

Factor IX recoveryBIOLOGICAL
1

Eligibility Criteria

Age12 Years+
Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Moderately to severe haemophilia B patient (FIX activity \< or equal to 2%) for whom the switch from pdFIX to BeneFIX has already been decided by the investigator
  • Previously treated patients (PTP) with \> or equal to 150 ED to any FIX product
  • Male patients, aged \> or equal to 12 years
  • Absolute CD4 count \> or equal to 300/microL
  • Normal platelet count (\> or equal to 100 000/microL)
  • Patient is in a non-bleeding state and has not received any coagulation FIX within five (5) days of recovery
  • Written informed consent obtained prior to study entry (for patients aged \< 18 years, parents' signature or subject legally acceptable representative obtained prior to study entry)

You may not qualify if:

  • Any other known bleeding disorder in addition to haemophilia B
  • History of, or current detectable factor IX inhibitor (\> or equal to 0.6 BU by Bethesda inhibitor assay)
  • History of anaphylaxis to any coagulation factor IX
  • Patient with a known hypersensitivity to hamster protein
  • Patient with a hypersensitivity to the active substance or to any of the excipients
  • Patient unable to be off FIX replacement therapy for at least 5 days without bleeding Patient with hepatic or renal impairment (ALT \[SGPT\] and AST \[SGOT\] \> 5 x Upper Limit Normal (ULN), total bilirubin \> 20mg/l, albumin \< 25 g/l, prothrombin time \> 1.25 x ULN, serum creatinine \> 1.25 x ULN)
  • Treatment with any investigational drug or device within the past 30 days
  • Any condition that, in the Investigator's judgment, makes participation in the study not advisable

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Dr. Lambert

Le Kremlin-Bicêtre, 94275, France

Location

Pr Chambost

Marseille, 13385, France

Location

Dr. Hassoun

Montmorency, 95160, France

Location

Pr Schved

Montpellier, 34291, France

Location

Dr. Rothschild

Paris, 75743, France

Location

Dr. Duillet

Rennes, 35033, France

Location

Dr. Borg

Rouen, 76031, France

Location

Pr Gruel

Tours, 37044, France

Location

MeSH Terms

Conditions

Hemophilia B

Condition Hierarchy (Ancestors)

Blood Coagulation Disorders, InheritedBlood Coagulation DisordersHematologic DiseasesHemic and Lymphatic DiseasesCoagulation Protein DisordersHemorrhagic DisordersGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGenetic Diseases, X-Linked

Results Point of Contact

Title
U. S. Contact Center
Organization
Wyeth
clintrialresults@wyeth.com

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

September 8, 2008

First Posted

September 9, 2008

Study Start

April 1, 2008

Primary Completion

January 1, 2009

Study Completion

January 1, 2009

Last Updated

June 8, 2011

Results First Posted

June 29, 2010

Record last verified: 2011-06

Locations

FR(8)