Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B

NCT01335061

Last updated date
Study Location
UMBAL Sveti Georgi, Klinika po hematologia
Plovdiv, , 4002, Bulgaria
Contact
1-800-718-1021

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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
12-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Documented history of moderately-severe to severe hemophilia B (FIX activity

- Male subjects, aged 12 years to 65 years.

- Subjects with at least 100 exposure days (EDs) to factor IX products.

- Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12-month period before the Screening visit.

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


- Subjects who have received FIX as a primary or secondary prophylaxis regimen within
the last 12 months prior to the Screening visit.


- Subjects who have had major surgery or an orthopedic surgical procedure within the
past 3 months prior to Screening visit.


- Subjects for which major surgery or orthopedic surgery is planned within the duration
of study participation.


- Subjects with a past history of, or current FIX inhibitor, defined as >ULN (upper
limit of normal) of the reporting laboratory.


- Subjects with a known hypersensitivity to any FIX product or hamster protein.

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Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B
Official Title  ICMJE A Multicenter, Open-label Study To Compare On-demand Treatment To A Prophylaxis Regimen Of Nonacog-alfa (Benefix) In Subjects With Moderately Severe To Severe Hemophilia B (Fix:c</=2%)
Brief Summary The purpose of this study will be to determine if a once-weekly prophylaxis regimen of BeneFIX in subjects with moderately severe to severe Hemophilia B is safe and effective.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Hemophilia B
Intervention  ICMJE
  • Biological: Nonacog alfa
    Period 1: During on-demand period, dosing at the discretion of investigator.
    Other Name: BeneFIX
  • Biological: Nonacog alfa
    Period 2: During the prophylaxis period, 100 IU/kg once weekly
    Other Name: BeneFIX
Study Arms  ICMJE BeneFIX
Interventions:
  • Biological: Nonacog alfa
  • Biological: Nonacog alfa
Publications * Not Provided

*   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: May 28, 2014)
25
Original Estimated Enrollment  ICMJE
 (submitted: April 12, 2011)
24
Actual Study Completion Date  ICMJE April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Documented history of moderately-severe to severe hemophilia B (FIX activity </=2%).
  • Male subjects, aged 12 years to 65 years.
  • Subjects with at least 100 exposure days (EDs) to factor IX products.
  • Subjects with a minimum of 12 bleeding episodes, 6 of which must be joint bleeds, in the 12-month period before the Screening visit.

Exclusion Criteria:

  • Subjects who have received FIX as a primary or secondary prophylaxis regimen within the last 12 months prior to the Screening visit.
  • Subjects who have had major surgery or an orthopedic surgical procedure within the past 3 months prior to Screening visit.
  • Subjects for which major surgery or orthopedic surgery is planned within the duration of study participation.
  • Subjects with a past history of, or current FIX inhibitor, defined as >ULN (upper limit of normal) of the reporting laboratory.
  • Subjects with a known hypersensitivity to any FIX product or hamster protein.
Sex/Gender  ICMJE
Sexes Eligible for Study:Male
Ages  ICMJE 12 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 Bulgaria,   Canada,   Croatia,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Singapore,   Turkey
Removed Location Countries United States
 
Administrative Information
NCT Number  ICMJE NCT01335061
Other Study ID Numbers  ICMJE B1821010
3090A1-3306 ( Other Identifier: Alias Study Number )
2011-000520-15 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date May 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP