Study Evaluating rFIX; BeneFIX® in Hemophilia B | NCT00093171

Studies
Study Evaluating rFIX; BeneFIX® in Hemophilia B

NCT00093171

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Status

Completed

Last Update Posted

Aug 21, 2009Estimated

Enrollment

23Actual

Phase

Phase 3

Conditions

Hemophilia B

Interventions

rFIX

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Not provided

Primary Completion Date

May 2005Actual

Completion Date

May 2005Actual

First Submitted Date

Oct 4, 2004

First Submission Date that Met QC Criteria

Oct 6, 2004

First Posted Date

Oct 7, 2004Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 20, 2009

Last Update Posted Date

Aug 21, 2009Estimated

Description Module

Brief Summary

The primary objective of this clinical research study is to assess the safety and efficacy of rFIX for a minimum of 6 months in previously treated patients (PTPs) with hemophilia B (FIX:C ≤2%) during standard-of-care treatment (on-demand, prophylaxis, and through major and minor surgical procedures).

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

23Actual

Name	Type	Description	Arm Group Labels	Other Names
rFIX	Drug

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Hemophilia B (FIX:C less than 2%)
Previous treatment of at least 150 exposure days using any FIX product
12 years of age and older

Exclusion Criteria:

The patient has a currently detectable factor IX inhibitor or a history of inhibitors. (A family history of inhibitors will not exclude the patient)
Known hypersensitivity to protein pharmaceuticals or agents related to the test article, e.g. hamster proteins
Patient has a genetic coagulation disorder other than hemophilia B

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

12 Years

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Medical Monitor, MD	Wyeth is now a wholly owned subsidiary of Pfizer	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
		Los Angeles	California	90027	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
40750723	Derived	Wojciechowski J, Gaitonde P, Hughes JH, Ravva P. Population Modeling of Factor IX Activity Following Administration of Fidanacogene Elaparvovec Gene Therapy in Participants with Hemophilia B. Clin Pharmacokinet. 2025 Oct;64(10):1531-1548. doi: 10.1007/s40262-025-01535-y. Epub 2025 Aug 1.
26196195	Derived

ID	Term
D025861	Blood Coagulation Disorders, Inherited
D001778	Blood Coagulation Disorders
D006402	Hematologic Diseases
D006425	Hemic and Lymphatic Diseases