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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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pfizer
ClinicalTrials.gov Identifier:
NCT01335061
First received: March 30, 2011
Last updated: May 28, 2014
Last verified: May 2014

March 30, 2011
May 28, 2014
September 2011
April 2014   (final data collection date for primary outcome measure)
Annualized number of bleeding episodes [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01335061 on ClinicalTrials.gov Archive Site
  • Assessment scores on a 4-point Response Scale for an on-demand bleeding episode, as assessed by subject/caregiver or investigator/qualified staff. The 4 point scale assessments are Excellent, Good, Moderate or No response. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • The number of BeneFIX infusions used to treat each bleed. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • The number of breakthrough (spontaneous/non-traumatic) bleeds within 48 hours of a prophylaxis dose of BeneFIX . [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • The average infusion dose and total factor consumption. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
  • The number of subjects with incidences of less-than-expected therapeutic effect (LETE) in the absence of confounding factors. There are 3 circumstances in which LETE can occur. In the on-demand or prophylaxis settings and for low recovery of Factor IX. [ Time Frame: Up to 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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</=2%)

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 </=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.
Male
12 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Bulgaria,   Canada,   Croatia,   Korea, Republic of,   Malaysia,   Mexico,   Poland,   Singapore,   Turkey
 
NCT01335061
B1821010, 3090A1-3306
Yes
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
May 2014

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