Trial record 1 of 1 for:
NCT00364182
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 |
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Recruitment Status :
Completed
First Posted : August 15, 2006
Results First Posted : August 23, 2011
Last Update Posted : October 4, 2011
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Sponsor:
Pfizer
Information provided by (Responsible Party):
Pfizer
- Study Details
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| 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 |
Participant Flow
| 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 |
|---|---|---|---|
 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 |
Baseline Characteristics
| 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 | |
|---|---|---|---|---|---|
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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 | |
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Baseline Analysis Population Description |
[Not Specified]
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Age Continuous
Mean (Standard Deviation) Unit of measure: Years |
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| 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) | ||
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Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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| Number Analyzed | 3 participants | 22 participants | 25 participants | 50 participants | |
| Female |
0 0.0%
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0 0.0%
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0 0.0%
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0 0.0%
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| Male |
3 100.0%
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22 100.0%
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25 100.0%
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50 100.0%
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Outcome Measures
Adverse Events
Limitations and Caveats
Although the protocol-defined endpoint was days lost from work or school after hemarthrosis, data was collected and reported in hours.
More Information
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 |
| EMail: | ClinicalTrials.gov_Inquiries@pfizer.com |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Pfizer |
| ClinicalTrials.gov Identifier: | NCT00364182 |
| 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 |