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Trial record 1 of 1 for:    NCT01154231
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BeneFIX Drug Use Results Survey [All-Case Surveillance]

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01154231
Recruitment Status : Completed
First Posted : June 30, 2010
Results First Posted : April 11, 2017
Last Update Posted : October 17, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date June 28, 2010
First Posted Date June 30, 2010
Results First Submitted Date February 28, 2017
Results First Posted Date April 11, 2017
Last Update Posted Date October 17, 2018
Study Start Date February 2010
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 28, 2017)
  • Number of Bleeding Episodes (Annual Bleeding Event Rate) During Periodic Replacement Therapy [ Time Frame: 2 years for PTPs, 1 year for PUPs ]
    Annual bleeding rate (ABR) was calculated as the number of total bleeding events occured during prophylaxis period devided by the period (events/year). ABR for other replacement treatment period was also calculated to evaluate the differences between types of treatment. If the period used for ABR calculation was less or equal than 7 days, the relevant data was regarded as missing.
  • Number of Administrations Required for Hemostasis for Bleeding Events [ Time Frame: 2 years for PTPs, 1 year for PUPs ]
    Mean number of administrations for hemostasis in replacement therapy for bleeding events.
Original Primary Outcome Measures
 (submitted: June 29, 2010)
Number of times of dosing required for hemosbleeding episodes [ Time Frame: 2 years ]
Change History
Current Secondary Outcome Measures
 (submitted: February 28, 2017)
Subjective Evaluation of Each Therapeutic Administration for Bleeding Episodes [ Time Frame: 2 years for PTPs, 1 year for PUPs ]
Propotion of subjects whose physicians evaluated the effect of BeneFIX for bleeding episodes as excellent or good was calculated.
Original Secondary Outcome Measures
 (submitted: June 29, 2010)
Subjective evaluation of each therapeutic administration for bleeding episodes [ Time Frame: 2 years ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title BeneFIX Drug Use Results Survey [All-Case Surveillance]
Official Title Benefix(Registered) Intravenous 500 1000 2000 Drug Use Results Survey (All-case Surveillance)
Brief Summary

The survey is intended to investigate the following matters, etc. under the actual use status after marketing in all patients who are administered this drug for a certain period of time after the launch.

  1. Occurrence status of adverse events
  2. Factors that may influence the safety
  3. Efficacy In addition, the following occurrence statuses will be investigated as priority items of the survey: Incidence rate of inhibitor, reduction in drug, efficacy, Allergic reaction, and Thrombosis.
Detailed Description

Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.

Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product ("Previously treated patients": hereinafter, "PTPs") or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time ("Previously untreated patients": hereinafter, "PUPs").

The definition of PUPs in this survey is "Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "EDs") or less."

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.
Condition Hemophilia B
Intervention Drug: Nonacog Alfa (Genetical Recombination)

Patients with hemophilia B (congenital blood coagulation factor IX deficiency) who are administered this drug.

Patients with hemophilia B are either patients for whom treatment was already started with a blood coagulation factor IX product ("Previously treated patients": hereinafter, "PTPs") or patients who have no history of treatment with a blood coagulation factor IX product in the past and for whom treatment will be started with this drug for the first time ("Previously untreated patients": hereinafter, "PUPs").

The definition of PUPs in this survey is "Patients in whom the total number of days of administration of a blood coagulation factor IX product other than this drug before administration of this drug was 3 exposure days (actual number of days of administration: hereinafter, "EDs") or less."

Other Name: BeneFIX
Study Groups/Cohorts Nonacog Alfa (Genetical Recombination)
Intervention: Drug: Nonacog Alfa (Genetical Recombination)
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 Completed
Actual Enrollment
 (submitted: September 14, 2015)
314
Original Estimated Enrollment
 (submitted: June 29, 2010)
300
Actual Study Completion Date February 27, 2017
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • All patients with hemophilia B scheduled to receive treatment with BeneFIX will be eligible for the surveillance.
  • No patient will be excluded because of prior inhibitor history; however, complete patient history and demographics will be collected.

Exclusion Criteria:

  • Patients not administered BeneFIX.
Sex/Gender Not Provided
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Japan
Removed Location Countries  
 
Administrative Information
NCT Number NCT01154231
Other Study ID Numbers 3090X1-4415
B1821004
B1821009 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Pfizer
Study Sponsor Pfizer
Collaborators Not Provided
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date September 2018