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Study Comparing On-Demand Treatment With Two Prophylaxis Regimens Of BeneFIX In Patients With Severe Hemophilia B

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ClinicalTrials.gov Identifier: NCT00364182
Recruitment Status : Completed
First Posted : August 15, 2006
Results First Posted : August 23, 2011
Last Update Posted : October 4, 2011
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Crossover Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Hemophilia B
Intervention Drug: Recombinant Coagulation Factor IX (BeneFIX)
Enrollment 50
Recruitment Details  
Pre-assignment Details 3 participants who enrolled in the study were not randomized to either prophylaxis treatment regimen, but participated in the study during the first on demand treatment period
Arm/Group Title Pre-Randomization BeneFIX OD1, Then 100 IU/kg, Then OD2, Then 50 IU/kg BeneFIX OD1 Then 50 IU/kg, Then OD2, Then 100 IU/kg
Hide Arm/Group Description Participants were enrolled and received BeneFix (recombinant coagulation factor IX) as intravenous (IV) bolus infusion in the first on-demand (OD1) period but were never randomized. BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 100 international units per kilogram (IU/kg) once per week (QW) for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 50 IU/kg twice weekly (BW) for 16 weeks prophylactically. Dosage form: IV bolus infusion. BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 50 IU/kg BW for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 100 IU/kg QW for 16 weeks prophylactically. Dosage form: IV bolus infusion.
Period Title: First Intervention
Started 3 22 25
Completed 0 22 25
Not Completed 3 0 0
Reason Not Completed
Secondary prophylaxis             1             0             0
Withdrawal by Subject             2             0             0
Period Title: Second Intervention
Started 0 22 25
Randomized 0 22 25
Completed 0 20 23
Not Completed 0 2 2
Reason Not Completed
non-compliance             0             1             1
Protocol Violation             0             1             0
Adverse Event             0             0             1
Period Title: Third Intervention
Started 0 20 23
Completed 0 19 22
Not Completed 0 1 1
Reason Not Completed
non-compliance             0             1             0
Lost to Follow-up             0             0             1
Period Title: Fourth Intervention
Started 0 19 22
Completed 0 19 22
Not Completed 0 0 0
Arm/Group Title Pre-Randomization BeneFIX OD1, Then 100 IU/kg, Then OD2, Then 50 IU/kg BeneFIX OD1 Then 50 IU/kg, Then OD2, Then 100 IU/kg Total
Hide Arm/Group Description Participants were enrolled and received BeneFix (recombinant coagulation factor IX) as intravenous (IV) bolus infusion in the first on-demand (OD1) period but were never randomized. BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 100 international units per kilogram (IU/kg) once per week (QW) for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 50 IU/kg twice weekly (BW) for 16 weeks prophylactically. Dosage form: IV bolus infusion. BeneFIX (recombinant coagulation factor IX) on-demand for 16 weeks (OD1), followed by 50 IU/kg BW for 16 weeks prophylactically, followed by 8 weeks BeneFIX on-demand (OD2), followed by 100 IU/kg QW for 16 weeks prophylactically. Dosage form: IV bolus infusion. Total of all reporting groups
Overall Number of Baseline Participants 3 22 25 50
Hide Baseline Analysis Population Description
[Not Specified]
Age Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 3 participants 22 participants 25 participants 50 participants
19.3  (4.5) 31.7  (13.4) 25.1  (14.4) 27.7  (13.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 3 participants 22 participants 25 participants 50 participants
Female
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Male
3
 100.0%
22
 100.0%
25
 100.0%
50
 100.0%
1.Primary Outcome
Title Annualized Number of Bleeding Episodes
Hide Description Annualized bleed rate (ABR) or number of bleeds per year derived for each participant for each treatment regimen by using the following formula: ABR = number of bleeds / (days on treatment regimen / 365.25)
Time Frame Baseline up to Week 56
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat (ITT) population: all enrolled participants
Arm/Group Title BeneFIX OD1 BeneFIX 100 IU/kg BeneFIX 50 IU/kg
Hide Arm/Group Description:
BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
Overall Number of Participants Analyzed 50 44 44
Least Squares Mean (95% Confidence Interval)
Unit of Measure: episodes
35.1
(28.8 to 41.4)
4.6
(2.1 to 7.2)
2.6
(-0.1 to 5.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BeneFIX OD1, BeneFIX 100 IU/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -30.5
Confidence Interval (2-Sided) 95%
-36.5 to -24.5
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BeneFIX OD1, BeneFIX 50 IU/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -32.5
Confidence Interval (2-Sided) 95%
-38.5 to -26.6
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BeneFIX 100 IU/kg, BeneFIX 50 IU/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2167
Comments P-values based on a model including terms for treatment regimen, treatment sequence, and the interaction of these terms with repeated measures on participants.
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value 2.0
Confidence Interval (2-Sided) 95%
-1.2 to 5.2
Estimation Comments [Not Specified]
2.Secondary Outcome
Title Amount of Sleep Measured by Sleep Diary After Hemarthrosis
Hide Description For each bleeding event, a diary was filled out that night and the subsequent night. Questions included: How long do you think you slept last night? Reported as average duration of sleep during study.
Time Frame 24 and 48 hours post-bleed
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title BeneFIX OD1 BeneFIX 100 IU/kg BeneFIX 50 IU/kg BeneFIX OD2
Hide Arm/Group Description:
BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
Overall Number of Participants Analyzed 50 44 44 43
Mean (Standard Deviation)
Unit of Measure: hours
24 hours post-bleed 7.5  (2.0) 7.3  (1.8) 7.1  (1.6) 7.4  (1.9)
48 hours post-bleed 7.9  (1.7) 7.8  (1.6) 7.5  (1.4) 8.0  (1.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BeneFIX OD1
Comments Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.1 to 0.6
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BeneFIX 100 IU/kg
Comments Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.021
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
0.1 to 0.8
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BeneFIX 50 IU/kg
Comments Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.004
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.6
Confidence Interval (2-Sided) 95%
0.2 to 0.9
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BeneFIX OD2
Comments Mean difference in duration of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.093
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 0.4
Confidence Interval (2-Sided) 95%
-0.1 to 0.8
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Quality of Sleep Measured by Sleep Diary After Hemarthrosis
Hide Description For each bleeding event, a diary was filled out that night and the subsequent night. Questions included: How would you describe the quality of your sleep last night? 1=Very Good, 2=Good, 3=Fair, 4=Poor, 5=Very Poor. Reported as quality of sleep during study.
Time Frame 24 and 48 hours post-bleed
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title BeneFIX OD1 BeneFIX 100 IU/kg BeneFIX 50 IU/kg BeneFIX OD2
Hide Arm/Group Description:
BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
Overall Number of Participants Analyzed 50 44 44 43
Mean (Standard Deviation)
Unit of Measure: Units on a scale
24 hours post-bleed 2.4  (0.9) 2.5  (0.9) 2.3  (0.9) 2.4  (0.9)
48 hours post-bleed 2.1  (0.7) 2.1  (0.8) 2.1  (0.7) 2.1  (0.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BeneFIX OD1
Comments Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.000
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.4 to -0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BeneFIX 100 IU/kg
Comments Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0000
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.5 to -0.2
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BeneFIX 50 IU/kg
Comments Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.002
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.5 to -0.1
Estimation Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection BeneFIX OD2
Comments Mean difference in quality of sleep on the first night (24 hours post-bleed) and the second night (48 hours post-bleed).
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.031
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -0.3
Confidence Interval (2-Sided) 95%
-0.5 to -0.0
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Acute Pain After Hemarthrosis
Hide Description For each bleeding event, a diary was filled out that night and the subsequent night and included a Brief Pain Inventory (BPI): self-reported scale that measured severity of pain experienced over the past 24 hours. Questions included How much pain right now? 0 (no pain) to 10 (pain as severe as you can imagine).
Time Frame 24 and 48 hours post-bleed
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title BeneFIX OD1 BeneFIX 100 IU/kg BeneFIX 50 IU/kg BeneFIX OD2
Hide Arm/Group Description:
BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
Overall Number of Participants Analyzed 50 44 44 43
Mean (Standard Deviation)
Unit of Measure: units on a scale
24 hours post-bleed 2.8  (2.1) 2.8  (2.0) 3.1  (2.2) 3.0  (2.1)
48 hours post-bleed 2.3  (1.6) 1.8  (1.2) 2.7  (1.5) 4.1  (2.4)
5.Secondary Outcome
Title Health-Related Productivity Questionnaire (HRPQ) Score: Hours Lost From Work or School at 24 Hours Post-bleed
Hide Description HRPQ: self-reported scale that measured for each bleed event, hours lost from work, school and housework because of hemophilia and its treatments. Mean and standard deviations calculated from measured values.
Time Frame 24 hours post-bleed
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title BeneFIX OD1 BeneFIX 100 IU/kg BeneFIX 50 IU/kg BeneFIX OD2
Hide Arm/Group Description:
BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
Overall Number of Participants Analyzed 50 44 44 43
Mean (Standard Deviation)
Unit of Measure: hours
Work missed 0.4  (1.6) 1.2  (2.6) 0.6  (1.9) 0.6  (1.3)
Housework couldn't do 0.7  (2.4) 0.3  (0.8) 0.4  (0.7) 0.2  (0.5)
Classwork couldn't do 0.8  (1.7) 0.7  (2.2) 0.4  (1.1) 0.0  (0.0)
6.Secondary Outcome
Title HRPQ Score: Hours Lost From Work or School at 48 Hours Post-bleed
Hide Description HRPQ: self-reported scale that measured for each bleed event, hours lost from work, school and housework because of hemophilia and its treatments. Mean and standard deviations calculated from measured values.
Time Frame 48 hours post-bleed
Hide Outcome Measure Data
Hide Analysis Population Description
ITT
Arm/Group Title BeneFIX OD1 BeneFIX 100 IU/kg BeneFIX 50 IU/kg BeneFIX OD2
Hide Arm/Group Description:
BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
Overall Number of Participants Analyzed 50 44 44 43
Mean (Standard Deviation)
Unit of Measure: hours
Work missed 0.2  (1.0) 0.7  (2.1) 0.1  (0.4) 0.2  (0.5)
Housework couldn't do 0.5  (1.4) 0.3  (0.7) 0.0  (0.2) 0.0  (0.0)
Classwork couldn't do 0.4  (1.2) 0.7  (2.4) 0.0  (0.0) 1.7  (2.6)
7.Secondary Outcome
Title 36-Item Short-Form Health Survey (SF-36): Physical Functioning Domain
Hide Description SF-36: standardized survey evaluating 8 aspects of functional health and well being: physical and social functioning, physical and emotional role limitations, bodily pain, general health, vitality, and mental health. The physical functioning domain score was an average of the individual physical functioning question scores across all time points, which was scaled 0-100 (100=highest level of functioning).
Time Frame Weeks 16, 32, and 56
Hide Outcome Measure Data
Hide Analysis Population Description
ITT; N=number of participants with evaluable data.
Arm/Group Title BeneFIX OD1 BeneFIX 100 IU/kg BeneFIX 50 IU/kg
Hide Arm/Group Description:
BeneFIX on-demand IV bolus infusion for 16 weeks (first intervention)
BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks
BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks
Overall Number of Participants Analyzed 40 35 34
Mean (Standard Deviation)
Unit of Measure: units on a scale
64  (26) 66  (25) 63  (28)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection BeneFIX OD1, BeneFIX 100 IU/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.544
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -2.1
Confidence Interval (2-Sided) 95%
-9.2 to 4.9
Estimation Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection BeneFIX OD1, BeneFIX 50 IU/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.592
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value -1.6
Confidence Interval (2-Sided) 95%
-7.5 to 4.3
Estimation Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection BeneFIX 100 IU/kg, BeneFIX 50 IU/kg
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.131
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Net)
Estimated Value 3.6
Confidence Interval (2-Sided) 95%
-1.1 to 8.4
Estimation Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description The same event may appear as both an adverse event (AE) and a serious AE (SAE). However, what is presented are distinct events. An event may be categorized as serious in 1 participant and as nonserious in another participant, or 1 participant may have experienced both a serious and nonserious event during the study.
 
Arm/Group Title BeneFIX OD1 BeneFIX 100 IU/kg BeneFIX 50 IU/kg BeneFIX OD2
Hide Arm/Group Description BeneFIX in an on-demand IV bolus infusion for 16 weeks (first intervention) BeneFIX 100 IU/kg IV bolus infusion QW for 16 weeks BeneFIX 50 IU/kg IV bolus infusion BW for 16 weeks BeneFIX on-demand IV bolus infusion for 8 weeks (third intervention)
All-Cause Mortality
BeneFIX OD1 BeneFIX 100 IU/kg BeneFIX 50 IU/kg BeneFIX OD2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
BeneFIX OD1 BeneFIX 100 IU/kg BeneFIX 50 IU/kg BeneFIX OD2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/50 (2.00%)   2/44 (4.55%)   2/44 (4.55%)   0/43 (0.00%) 
Injury, poisoning and procedural complications         
Ulna fracture * 1  1/50 (2.00%)  0/44 (0.00%)  0/44 (0.00%)  0/43 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthropathy * 1  0/50 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/43 (0.00%) 
Back pain * 1  0/50 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/43 (0.00%) 
Renal and urinary disorders         
Calculus urinary * 1  0/50 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/43 (0.00%) 
Renal colic * 1  0/50 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/43 (0.00%) 
Testicular pain * 1  0/50 (0.00%)  0/44 (0.00%)  1/44 (2.27%)  0/43 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Pneumothorax * 1  0/50 (0.00%)  1/44 (2.27%)  0/44 (0.00%)  0/43 (0.00%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
BeneFIX OD1 BeneFIX 100 IU/kg BeneFIX 50 IU/kg BeneFIX OD2
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/50 (16.00%)   8/44 (18.18%)   4/44 (9.09%)   4/43 (9.30%) 
Musculoskeletal and connective tissue disorders         
Arthralgia * 1  5/50 (10.00%)  4/44 (9.09%)  2/44 (4.55%)  2/43 (4.65%) 
Nervous system disorders         
Headache * 1  3/50 (6.00%)  6/44 (13.64%)  2/44 (4.55%)  2/43 (4.65%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA 12.1
Although the protocol-defined endpoint was days lost from work or school after hemarthrosis, data was collected and reported in hours.
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.
Pfizer has the right to review disclosures, requesting a delay of less than 60 days. Investigator will postpone single center publications until after disclosure of pooled data (all sites), less than 12 months from study completion/termination at all participating sites. Investigator may not disclose previously undisclosed confidential information other than study results.
Results Point of Contact
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT00364182     History of Changes
Other Study ID Numbers: 3090A1-400
B1821002 ( Other Identifier: Pfizer )
First Submitted: August 14, 2006
First Posted: August 15, 2006
Results First Submitted: July 25, 2011
Results First Posted: August 23, 2011
Last Update Posted: October 4, 2011