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

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NCT01335061

Last updated on May 9, 2018
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FOR MORE INFORMATION
Study Location
UMBAL Sveti Georgi, Klinika po hematologia
Plovdiv, , 4002 Bulgaria
See other locations
Contact
1-800-718-1021
ClinicalTrials.gov_Inqui[email protected]
Related Links
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 =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
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.

NCT01335061
Pfizer
Completed
Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B

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Study To Compare On-Demand Treatment To A Prophylaxis Regimen Of BeneFIX In Subjects With Moderately Severe to Severe Hemophilia B
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
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.
Not Provided
Interventional
Phase 3
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Hemophilia B
  • 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
BeneFIX
Interventions:
  • Biological: Nonacog alfa
  • Biological: Nonacog alfa
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
25
April 2014
April 2014   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • 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:

  • 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.
Sexes Eligible for Study: Male
12 Years to 65 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   Croatia,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Singapore,   Turkey
United States
 
NCT01335061
B1821010
3090A1-3306 ( Other Identifier: Alias Study Number )
2011-000520-15 ( EudraCT Number )
Yes
Not Provided
Not Provided
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2015

ICMJE     Data element required by the

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

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