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Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B

Last updated on October 14, 2019

FOR MORE INFORMATION
Study Location
Pfizer Investigational Site
Phoenix, Arizona, 85016 United States
Contact
1-800-718-1021
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Hemophilia B
Sex
Male
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6-65 years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Documented history of moderately severe or severe hemophilia B (FIX:C less than or
equal to 2%)

- Male subjects, aged 6 years to 65 years.

- Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in
the 12 months before screening.

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

- Subjects currently utilizing FIX primary prophylaxis.

- Subjects with HIV+ who have a CD4 count less than 200

- Subjects with hepatic or renal impairment.

- Prothrombin time or International Normalized Ration more than 1.5 times the upper
limit of normal.

- Major surgery or an orthopedic surgical procedure within the past 3 months or is
planned within the duration of participation in this study.

- Past history of, or current FIX inhibitor.

- Hypersensitivity to any FIX product or hamster protein.

- Exposure to any investigational drug, except for rFIX-R, or device within 30 days of
providing consent/assent (as appropriate) for this study.

- Bleeding disorders other than hemophilia B.

- Concurrent inflammatory disease that in the investigator's judgment could confound
the study results.

NCT00364182
Pfizer
Completed
Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B

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Descriptive Information
Brief Title  ICMJE Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B
Official Title  ICMJE A Multicenter, Open-Label Study To Compare On-Demand Treatment With 2 Prophylaxis Regimens of Recombinant Coagulation Factor IX (BeneFIX) Reformulated Drug Product (rFIX-R) In Subjects With Severe Hemophilia B
Brief Summary

This study is designed to evaluate BeneFIX infused as prophylaxis regimens, compared with BeneFIX administered as an on-demand regimen only. In the trial, subjects will participate in 4 study periods. The first period is a 16-week on-demand treatment, during which subjects will utilize BeneFIX to treat bleeding events episodically only as they occur (i.e., on-demand treatment). At the end of this period, subjects will be randomly assigned to 1 of 2 BeneFIX prophylaxis regimens: either 100 IU/kg once weekly or 50 IU/kg twice weekly, and followed for 16 weeks. At the end of this period, subjects will use on-demand treatment for 8 weeks. The purpose of this 8-week period is to mitigate the potential carry-over effect of the prior prophylaxis regimen on bleeding frequency. Following this 8-week on-demand treatment, subjects will cross-over and receive the alternate study prophylactic regimen for 16 weeks.

The primary endpoint is annualized number of bleeding episodes, compared between the first on-demand period and each of the prophylaxis regimens. A comparison of annualized bleeding episodes between the two prophylaxis regimens will also be performed. Subject-reported outcomes will also be collected using a patient diary. At 24 and 48 hours following the onset of each joint bleeding episode, information on pain, sleep, and work will be collected. Additional data on physical functioning will be recorded on the diary at the end of the 16-week on-demand period, and at the end of each prophylaxis period. Information on safety will also be collected.

Each subject will participate in this study for approximately 59 weeks (15 months), including a screening period of up to 3 weeks, an initial 16-week on-demand period, two prophylaxis treatment periods of 16 weeks each, separated by an 8-week on-demand treatment period.

A modified FIX recovery study will be performed once during each prophylaxis period.

The study diary will also be used by subjects to collect secondary endpoints. These endpoints, which are subject-reported outcomes, will be recorded in the diary at 24 and 48 hours following the onset of each joint bleeding episode. Additional data on physical functioning will be recorded on the diary at the end of the 16-week on-demand period, and at the end of each prophylaxis period.

Patients will be recruited in the United States, Canada, Europe and Russia.

Detailed DescriptionNot Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Hemophilia B
Intervention  ICMJE
  • Drug: Recombinant Coagulation Factor IX (BeneFIX)
    100 IU/kg once weekly then crossover to 50 IU/kg twice weekly
  • Drug: Recombinant Coagulation Factor IX (BeneFIX)
    50 IU/kg twice weekly then crossover to 100 IU/kg once weekly
Study Arms  ICMJE
  • Experimental: A
    Intervention: Drug: Recombinant Coagulation Factor IX (BeneFIX)
  • Experimental: B
    Intervention: Drug: Recombinant Coagulation Factor IX (BeneFIX)
Publications *


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 25, 2010)
50
Original Enrollment  ICMJE
 (submitted: August 14, 2006)
40
Actual Study Completion Date  ICMJE October 2010
Actual Primary Completion DateOctober 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented history of moderately severe or severe hemophilia B (FIX:C less than or equal to 2%)
  • Male subjects, aged 6 years to 65 years.
  • Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12 months before screening.

Exclusion Criteria:

  • Subjects currently utilizing FIX primary prophylaxis.
  • Subjects with HIV+ who have a CD4 count less than 200
  • Subjects with hepatic or renal impairment.
  • Prothrombin time or International Normalized Ration more than 1.5 times the upper limit of normal.
  • Major surgery or an orthopedic surgical procedure within the past 3 months or is planned within the duration of participation in this study.
  • Past history of, or current FIX inhibitor.
  • Hypersensitivity to any FIX product or hamster protein.
  • Exposure to any investigational drug, except for rFIX-R, or device within 30 days of providing consent/assent (as appropriate) for this study.
  • Bleeding disorders other than hemophilia B.
  • Concurrent inflammatory disease that in the investigator's judgment could confound the study results.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 6 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Croatia,   Hungary,   Italy,   Romania,   Russian Federation,   Serbia,   Spain,   United States
Removed Location CountriesBelgium,   Germany
 
Administrative Information
NCT Number  ICMJE NCT00364182
Other Study ID Numbers  ICMJE 3090A1-400
B1821002 ( Other Identifier: Pfizer )
Has Data Monitoring CommitteeNo
U.S. FDA-regulated ProductNot Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateAugust 2011

ICMJE     Data element required by the

International Committee of Medical Journal Editors
and the
World Health Organization ICTRP

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