NCT00581126

Brief Summary

To assess efficacy and safety of BeneFix® for prophylaxis in "Short-term" therapy and on demand therapy for all bleeding episodes of subjects with hemophilia B.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2001

Typical duration for phase_4

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

December 1, 2001

Completed
2.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2004

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

December 21, 2007

Completed
6 days until next milestone

First Posted

Study publicly available on registry

December 27, 2007

Completed
Last Updated

December 27, 2007

Status Verified

December 1, 2007

First QC Date

December 21, 2007

Last Update Submit

December 26, 2007

Conditions

Hemophilia B

Keywords

BENEFIXHemophilia B

Outcome Measures

Primary Outcomes (1)

  • The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding.

    9 months

Secondary Outcomes (1)

  • The secondary variables will be hemostasis and blood loss during and after surgery.

    9 months

Study Arms (1)

1

EXPERIMENTAL

Patients will receive Benefix IV according to blood amount

Drug: Recombinant Factor IX Coagulation

Interventions

Recombinant Factor IX CoagulationDRUG

Benefix IV each 12 hours for 2 a 5 days

1

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with moderate to severe hemophilia B ( \< 5% circulating factor IX activity) having acute hemorrhage or requiring "short-term therapy" for intermittent secondary prophylaxis regimens.
  • HIV seropositive ( asymptomatic) or seronegative subjects.
  • No history or detectable inhibitors.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

Study Officials

  • Medical Monitor

    Wyeth is now a wholly owned subsidiary of Pfizer

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

December 21, 2007

First Posted

December 27, 2007

Study Start

December 1, 2001

Study Completion

July 1, 2004

Last Updated

December 27, 2007

Record last verified: 2007-12