Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-02-23 @ 9:21 PM
Study NCT ID:
NCT00866606
Status:
COMPLETED
Last Update Posted:
2011-04-05
First Post:
2009-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D002836', 'term': 'Hemophilia B'}], 'ancestors': [{'id': 'D025861', 'term': 'Blood Coagulation Disorders, Inherited'}, {'id': 'D001778', 'term': 'Blood Coagulation Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D020147', 'term': 'Coagulation Protein Disorders'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D040181', 'term': 'Genetic Diseases, X-Linked'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005164', 'term': 'Factor IX'}], 'ancestors': [{'id': 'D004792', 'term': 'Enzyme Precursors'}, {'id': 'D045762', 'term': 'Enzymes and Coenzymes'}, {'id': 'D001779', 'term': 'Blood Coagulation Factors'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011498', 'term': 'Protein Precursors'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'ClinicalTrials.gov_Inquiries@pfizer.com', 'phone': '1-800-718-1021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc.'}, 'certainAgreement': {'otherDetails': '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.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From screening until 30 days after the last visit (Month 6/Final/Early Termination visit', 'description': 'The same event may appear as both an AE and a SAE. However, what is presented are distinct events. An event may be categorized as serious in one participant and as non-serious in another participant, or one participant may have experienced both a serious and non-serious event during the study.', 'eventGroups': [{'id': 'EG000', 'title': 'BeneFactor IX (BeneFIX)', 'description': "Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital).", 'otherNumAtRisk': 35, 'otherNumAffected': 19, 'seriousNumAtRisk': 35, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Anemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Abdominal pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fatigue', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Inflammation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Edema peripheral', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Fall', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Joint Sprain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Injury, poisoning and procedural complications', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Alanine aminotransferase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hematocrit abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hemoglobin abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Red blood cell count abnormal', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Investigations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Synovitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Musculoskeletal and connective tissue disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'seriousEvents': [{'term': 'Hemorrhage intracranial', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}, {'term': 'Hemophilia B with anti factor IX', 'stats': [{'groupId': 'EG000', 'numAtRisk': 35, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Congenital, familial and genetic disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFactor IX (BeneFIX)', 'description': "Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital)."}], 'classes': [{'categories': [{'measurements': [{'value': '1.70', 'spread': '0.72', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '8 hours post infusion', 'description': 'Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.'}, {'type': 'PRIMARY', 'title': 'Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFactor IX (BeneFIX)', 'description': "Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital)."}], 'classes': [{'categories': [{'measurements': [{'value': '1.58', 'spread': '0.71', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': '24 hours post infusion', 'description': 'Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.', 'unitOfMeasure': 'Units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.'}, {'type': 'PRIMARY', 'title': 'Percentage of Participants With FIX Inhibitor Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFactor IX (BeneFIX)', 'description': "Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital)."}], 'classes': [{'title': 'Total (n=35)', 'categories': [{'measurements': [{'value': '2.86', 'groupId': 'OG000'}]}]}, {'title': 'MTP (n=24)', 'categories': [{'measurements': [{'value': '4.17', 'groupId': 'OG000'}]}]}, {'title': 'PTP (n=11)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 months', 'description': 'Incidence of FIX inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory with Nijmegen assay result \\>=0.6 Bethesda Unit (BU). Incidence was stratified by participant exposure history - Minimally Treated Patients (MTPs): those who had received at least one prior FIX infusion, and \\<= 100 documented Exposure Days (EDs); while Previously Treated Patients (PTPs): those who had received \\>100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': "Safety Set (SS) population included all enrolled participants who had taken at least 1 dose of drug.The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each visit respectively."}, {'type': 'SECONDARY', 'title': 'Number of Infusions Required to Treat Each Bleed', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFactor IX (BeneFIX)', 'description': "Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital)."}], 'classes': [{'categories': [{'measurements': [{'value': '1.20', 'spread': '0.86', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline up to 6 months', 'description': 'The number of BeneFIX infusions required to treat each bleeding episode were analyzed. The average frequency of BeneFIX infusions per hemorrhage incidence to treat every hemorrhage was equal to the total number of injections throughout the study divided by total number of hemorrhagic events.', 'unitOfMeasure': 'Infusions', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.'}, {'type': 'SECONDARY', 'title': 'FIX Incremental Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFactor IX (BeneFIX)', 'description': "Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital)."}], 'classes': [{'title': 'Visit 2 (n=30)', 'categories': [{'measurements': [{'value': '0.760', 'spread': '0.222', 'groupId': 'OG000'}]}]}, {'title': 'Visit 4 (n=31)', 'categories': [{'measurements': [{'value': '0.727', 'spread': '0.275', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline (Visit 2) up to 6 months (Visit 4)', 'description': 'FIX recovery was assessed by evaluating FIX:C after initial exposure and following 6 months of repeated exposures to BeneFIX. A modified FIX recovery study was performed at Day 1 (Visit 2) and Month 6/Final/Early Termination visits (Visit 4) and when clinically indicated at the applicable on-demand visits. Blood samples for determination of FIX:C were collected immediately before BeneFIX infusion and at 30 minutes (±5 minutes) after the start of infusion. Post-infusion blood samples were collected via venipuncture in arm contralateral to arm used for infusion.', 'unitOfMeasure': 'IU/dL per IU/kg', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment. The 'n' is signifying those participants who received study drug and were evaluated for this measure at the timepoint for each visit respectively."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Less Than Expected Therapeutic Effect (LETE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFactor IX (BeneFIX)', 'description': "Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital)."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 months', 'description': 'The incidence of LETE for on-demand treatment was defined as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'FAS population included all participants who were treated and had at least 1 evaluable efficacy assessment after treatment.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Allergic-Type Allergic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFactor IX (BeneFIX)', 'description': "Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital)."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 months', 'description': 'Hypersensitivity to undesirable (damaging, discomfort-producing and sometimes fatal) reactions produced by the normal immune system. Hypersensitivity reactions require a pre-sensitized (immune) state of the host.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SS population included all enrolled participants who had taken at least 1 dose of drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Thrombosis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFactor IX (BeneFIX)', 'description': "Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital)."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 months', 'description': 'Thrombosis is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. When a blood vessel is injured, the body uses platelets and fibrin to form a blood clot to prevent blood loss.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SS population included all enrolled participants who had taken at least 1 dose of drug.'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Red Blood Cell (RBC) Agglutination', 'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFactor IX (BeneFIX)', 'description': "Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital)."}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 6 months', 'description': 'RBC Agglutination is the clumping of red blood cells in the presence of an antibody. The antibody or other molecule bonded multiple particles and joined them, creating a large complex.', 'unitOfMeasure': 'Percentage of Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'SS population included all enrolled participants who had taken at least 1 dose of drug.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BeneFactor IX (BeneFIX)', 'description': "Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital)."}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '35'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '31'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}]}, {'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Participants were enrolled in six centers in China.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '35', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'BeneFactor IX (BeneFIX)', 'description': "Participants received on-demand treatments with BeneFIX according to investigator's prescription over a 6-month (calendar day) period. A single 75 International Unit (IU)/kg (±5 IU/kg) intravenous (IV) bolus infusion of BeneFIX was given for recovery assessments. All BeneFIX administrations occurred in the clinic (hospital)."}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '25.7', 'spread': '13.6', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '35', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-04-01', 'studyFirstSubmitDate': '2009-03-19', 'resultsFirstSubmitDate': '2010-12-14', 'studyFirstSubmitQcDate': '2009-03-19', 'lastUpdatePostDateStruct': {'date': '2011-04-05', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2010-12-14', 'studyFirstPostDateStruct': {'date': '2009-03-20', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Investigator Hemostatic Efficacy Assessment of Participants After 8 Hours Post Infusion', 'timeFrame': '8 hours post infusion', 'description': 'Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.'}, {'measure': 'Investigator Hemostatic Efficacy Assessment of Participants After 24 Hours Post Infusion', 'timeFrame': '24 hours post infusion', 'description': 'Investigator Hemostatic Efficacy Assessment was based on response of bleeding episodes to BeneFIX treatment on 4-point rating scale: Excellent(1): definite pain relief or improvement in signs of bleeding starting within 8 hrs after infusion, with no additional infusion; Good(2): definite pain relief or improvement in signs of bleeding starting within 8 hrs or following infusion; Moderate(3): probable or slight improvement starting after 8 hours following infusion; No Response(4): no improvement at all between infusions or during 24 hour interval following an infusion, or condition worsens.'}, {'measure': 'Percentage of Participants With FIX Inhibitor Development', 'timeFrame': 'Baseline up to 6 months', 'description': 'Incidence of FIX inhibitor was defined as any result determined as positive at local laboratory, and confirmed at central laboratory with Nijmegen assay result \\>=0.6 Bethesda Unit (BU). Incidence was stratified by participant exposure history - Minimally Treated Patients (MTPs): those who had received at least one prior FIX infusion, and \\<= 100 documented Exposure Days (EDs); while Previously Treated Patients (PTPs): those who had received \\>100 documented prior EDs. When number of prior EDs for an individual was not known to be at least 100, participants were included in the MTP population.'}], 'secondaryOutcomes': [{'measure': 'Number of Infusions Required to Treat Each Bleed', 'timeFrame': 'Baseline up to 6 months', 'description': 'The number of BeneFIX infusions required to treat each bleeding episode were analyzed. The average frequency of BeneFIX infusions per hemorrhage incidence to treat every hemorrhage was equal to the total number of injections throughout the study divided by total number of hemorrhagic events.'}, {'measure': 'FIX Incremental Recovery', 'timeFrame': 'Baseline (Visit 2) up to 6 months (Visit 4)', 'description': 'FIX recovery was assessed by evaluating FIX:C after initial exposure and following 6 months of repeated exposures to BeneFIX. A modified FIX recovery study was performed at Day 1 (Visit 2) and Month 6/Final/Early Termination visits (Visit 4) and when clinically indicated at the applicable on-demand visits. Blood samples for determination of FIX:C were collected immediately before BeneFIX infusion and at 30 minutes (±5 minutes) after the start of infusion. Post-infusion blood samples were collected via venipuncture in arm contralateral to arm used for infusion.'}, {'measure': 'Percentage of Participants With Less Than Expected Therapeutic Effect (LETE)', 'timeFrame': 'Baseline up to 6 months', 'description': 'The incidence of LETE for on-demand treatment was defined as no response after each of 2 successive infusions within 24 hours for the same bleeding event in the absence of confounding factors.'}, {'measure': 'Percentage of Participants With Allergic-Type Allergic Reactions', 'timeFrame': 'Baseline up to 6 months', 'description': 'Hypersensitivity to undesirable (damaging, discomfort-producing and sometimes fatal) reactions produced by the normal immune system. Hypersensitivity reactions require a pre-sensitized (immune) state of the host.'}, {'measure': 'Percentage of Participants With Thrombosis', 'timeFrame': 'Baseline up to 6 months', 'description': 'Thrombosis is the formation of a blood clot (thrombus) inside a blood vessel, obstructing the flow of blood through the circulatory system. When a blood vessel is injured, the body uses platelets and fibrin to form a blood clot to prevent blood loss.'}, {'measure': 'Percentage of Participants With Red Blood Cell (RBC) Agglutination', 'timeFrame': 'Baseline up to 6 months', 'description': 'RBC Agglutination is the clumping of red blood cells in the presence of an antibody. The antibody or other molecule bonded multiple particles and joined them, creating a large complex.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['On-demand treatment', 'Hemostatic efficacy', 'Factor IX activity', 'Factor IX recovery', 'Factor IX inhibitor', 'Chinese'], 'conditions': ['Hemophilia B']}, 'referencesModule': {'references': [{'pmid': '22776196', 'type': 'DERIVED', 'citation': "Yang R, Zhao Y, Wang X, Sun J, Jin J, Wu D, Charnigo R, O'Brien A, Zhong Z, Rendo P. Evaluation of the safety and efficacy of recombinant factor IX (nonacog alfa) in minimally treated and previously treated Chinese patients with haemophilia B. Haemophilia. 2012 Sep;18(5):e374-8. doi: 10.1111/j.1365-2516.2012.02907.x. Epub 2012 Jul 9. No abstract available."}], 'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=3090A1-3305&StudyName=Study%20Evaluating%20On-Demand%20Treatment%20With%20BeneFIX%20In%20Chinese%20Subjects', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of on-demand treatment with BeneFIX in Chinese hemophilia B subjects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects equal or more than 6 years of age with mild, moderate or severe hemophilia B (FIX activity: more than 5%, 1-5%, or less than 1%, respectively)\n* Subjects with previous exposure to FIX replacement therapy\n* If HIV positive, documented CD4 count more than 200/µL within 6 months of study entry\n\nExclusion Criteria:\n\n* Diagnosed with any bleeding disorder in addition to hemophilia B\n* Current FIX inhibitor or history of FIX inhibitor (defined as \\>ULN of the reporting laboratory)\n* Subject has no history of exposure to FIX products (previously untreated patient \\[PUP\\])\n* Subject is currently utilizing primary FIX prophylaxis\n* Subjects anticipating elective surgery that may be planned to occur in the 6 months following study entry\n* Treated with immunomodulatory therapy within 30 days prior to study entry or planned use for the duration of their study participation\n* Participated in another investigational drug or device study within 30 days prior to study entry or planned participation for the duration of their study participation\n* Subjects with a known hypersensitivity to hamster protein\n* Significant hepatic or renal impairment (ALT and AST \\>5 x ULN, bilirubin \\>2 mg/dL or serum creatinine \\>1.25 x ULN)\n* Prothrombin Time \\>1.5 x ULN\n* Platelet count \\<80,000/µL\n* Pregnant or breastfeeding women\n* Unwilling or unable to follow the terms of the protocol\n* Any condition which may compromise the subject's ability to comply with and/or perform study-related activities or that poses a clinical contraindication to study participation, in the opinion of the Investigator or Sponsor"}, 'identificationModule': {'nctId': 'NCT00866606', 'briefTitle': 'Study Evaluating On-Demand Treatment With BeneFIX In Chinese Subjects', 'organization': {'class': 'INDUSTRY', 'fullName': 'Wyeth is now a wholly owned subsidiary of Pfizer'}, 'officialTitle': 'An Evaluation Of The Safety And Efficacy Of On-Demand Treatment With BeneFIX (Nonacog Alfa, Recombinant Factor IX) In Chinese Subjects With Hemophilia B', 'orgStudyIdInfo': {'id': '3090A1-3305'}, 'secondaryIdInfos': [{'id': 'B1821004'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Benefix', 'description': 'Subjects received on-demand treatments with BeneFIX over a 6-month (calendar day) period.', 'interventionNames': ['Biological: Benefix']}], 'interventions': [{'name': 'Benefix', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['Benefix']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510515', 'city': 'Guangzhou', 'state': 'Guangzhou', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '215006', 'city': 'Suzhou', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 31.30408, 'lon': 120.59538}}, {'zip': '300020', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'zip': '310003', 'city': 'Hangzhou', 'state': 'Zhejiang', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}, {'zip': '100730', 'city': 'Beijing', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '200025', 'city': 'Shanghai', 'country': 'China', 'facility': 'Pfizer Investigational Site', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wyeth is now a wholly owned subsidiary of Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Director, Clinical Trial Disclosure Group', 'oldOrganization': 'Pfizer, Inc'}}}}