Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 41 of 82 for:    bleeding episodes | ( Map: France )

Study Evaluating BeneFIX in Patients With Haemophilia B, Previously Treated With Plasma Derived Factor IX

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: NCT00749476
Recruitment Status : Completed
First Posted : September 9, 2008
Results First Posted : June 29, 2010
Last Update Posted : June 8, 2011
Sponsor:
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Hemophilia B
Intervention Biological: Factor IX recovery
Enrollment 1
Recruitment Details Patients were recruited in France from May 2008 to January 2009.
Pre-assignment Details Before enrollment there was up to a 14 day screening period and the investigator reviewed the subject's medical history and medications to ensure that the subject was in good health and met all of the inclusion criteria and none of the exclusion criteria.
Arm/Group Title BeneFIX
Hide Arm/Group Description Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
Period Title: Overall Study
Started 1
Completed 1
Not Completed 0
Arm/Group Title BeneFIX
Hide Arm/Group Description Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
Overall Number of Baseline Participants 1
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1 participants
27.0  (0.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1 participants
Female
0
   0.0%
Male
1
 100.0%
1.Primary Outcome
Title Number of Participants Reporting Efficacy
Time Frame 4 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to Treat (ITT) population. Due to low number of subjects that completed, no descriptive statistics for the efficacy endpoints are provided.
Arm/Group Title BeneFIX
Hide Arm/Group Description:
Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
Overall Number of Participants Analyzed 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title BeneFIX
Hide Arm/Group Description Plasma-derived FIX recovery with a dose of 50 ± 5 IU/kg before the conversion, BeneFIX recovery with a dose of 50 ± 5 IU/kg after the conversion, treatment with BeneFIX during the next 3 months.
All-Cause Mortality
BeneFIX
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BeneFIX
Affected / at Risk (%)
Total   1/1 (100.00%) 
Infections and infestations   
Herpes simplex type-2 (HSV-2) meningitis *  1/1 (100.00%) 
*
Indicates events were collected by non-systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
BeneFIX
Affected / at Risk (%)
Total   1/1 (100.00%) 
Gastrointestinal disorders   
Diarrhea *  1/1 (100.00%) 
Musculoskeletal and connective tissue disorders   
Lower back pain *  1/1 (100.00%) 
Renal and urinary disorders   
Acute renal failure *  1/1 (100.00%) 
Respiratory, thoracic and mediastinal disorders   
Allergic rhinitis *  1/1 (100.00%) 
*
Indicates events were collected by non-systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The PIs agreed to allow the sponsor 60 days to review and require changes to presentations or publications but only to protect confidential information and intellectual property, and for the sponsor to file a patent application, as applicable. The PIs also agreed for data to be presented first as a joint, multi-center publication.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: U. S. Contact Center
Organization: Wyeth
EMail: clintrialresults@wyeth.com
Layout table for additonal information
Responsible Party: Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
ClinicalTrials.gov Identifier: NCT00749476     History of Changes
Other Study ID Numbers: 3090X1-4405
First Submitted: September 8, 2008
First Posted: September 9, 2008
Results First Submitted: January 29, 2010
Results First Posted: June 29, 2010
Last Update Posted: June 8, 2011