Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
This study has been completed.
Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00866606
First received: March 19, 2009
Last updated: April 1, 2011
Last verified: April 2011
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Tracking Information | |||||
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First Received Date ICMJE | March 19, 2009 | ||||
Last Updated Date | April 1, 2011 | ||||
Start Date ICMJE | February 2009 | ||||
Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
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Original Primary Outcome Measures ICMJE |
The subject's response to treatment of bleeding episodes with BeneFIX will be evaluated by the Investigator using a 4-point rating scale. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||
Change History | Complete list of historical versions of study NCT00866606 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE |
the number of infusions required to resolve bleeding episodes; the incidence of less than expected therapeutic effect (LETE) [ Time Frame: 6 months ] [ Designated as safety issue: Yes ] | ||||
Current Other Outcome Measures ICMJE | |||||
Original Other Outcome Measures ICMJE | |||||
Descriptive Information | |||||
Brief Title ICMJE | Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects | ||||
Official Title ICMJE | An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B | ||||
Brief Summary | This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects. |
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Detailed Description | |||||
Study Type ICMJE | Interventional | ||||
Study Phase | Phase 3 | ||||
Study Design ICMJE | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
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Condition ICMJE | Hemophilia B | ||||
Intervention ICMJE | Biological: Benefix
BeneFIX for on-demand treatment of bleeding episodes were according to investigator prescription. FIX recovery was assessed by determining the FIX activity (FIX:C) levels in individual subjects. BeneFIX dosage for recovery assessments: single 75 IU/kg (±5 IU/kg) IV bolus infusion. |
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Study Arm (s) | Experimental: Benefix
Subjects received on-demand treatments with BeneFIX over a 6-month (calendar day) period.
Intervention: Biological: Benefix |
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Publications * | |||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Completed | ||||
Enrollment ICMJE | 35 | ||||
Completion Date | December 2009 | ||||
Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | 6 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Location Countries ICMJE | China | ||||
Administrative Information | |||||
NCT Number ICMJE | NCT00866606 | ||||
Other Study ID Numbers ICMJE | 3090A1-3305, B1821004 | ||||
Has Data Monitoring Committee | No | ||||
Responsible Party | Director, Clinical Trial Disclosure Group, Pfizer, Inc | ||||
Study Sponsor ICMJE | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
Collaborators ICMJE | |||||
Investigators ICMJE |
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Information Provided By | Wyeth is now a wholly owned subsidiary of Pfizer | ||||
Verification Date | April 2011 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |