Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2026-02-11 @ 7:52 PM
Study NCT ID:
NCT02213250
Status:
COMPLETED
Last Update Posted:
2016-07-25
First Post:
2014-08-07
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B
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': '(001)8007181021', 'title': 'Pfizer ClinicalTrials.gov Call Center', 'organization': 'Pfizer, Inc'}, 'certainAgreement': {'otherDetails': 'Restriction Description: 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 the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.', 'eventGroups': [{'id': 'EG000', 'title': 'BeneFIX 50 IU/kg', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.', 'otherNumAtRisk': 12, 'otherNumAffected': 0, 'seriousNumAtRisk': 12, 'seriousNumAffected': 0}], 'frequencyThreshold': '0.05'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Maximum Observed Plasma Concentration (Cmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg; >=6 and <12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}, {'id': 'OG001', 'title': 'BeneFIX 50 IU/kg; Age Group:>=12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.3880', 'spread': '26', 'groupId': 'OG000'}, {'value': '0.4226', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'unitOfMeasure': 'IU/milliliter (IU/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The pharmacokinetics (PK) parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg; >=6 and <12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}, {'id': 'OG001', 'title': 'BeneFIX 50 IU/kg; Age Group:>=12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.930', 'spread': '18', 'groupId': 'OG000'}, {'value': '9.707', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'unitOfMeasure': 'IU*hour/milliliter (IU*hr/mL)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.'}, {'type': 'PRIMARY', 'title': 'Area Under the Concentration Time Curve From Time 0 to Infinity (AUCinf)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg; Age Group>=6 and <12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}, {'id': 'OG001', 'title': 'BeneFIX 50 IU/kg; Age Group:>=12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '7.841', 'spread': '16', 'groupId': 'OG000'}, {'value': '11.66', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'unitOfMeasure': 'IU*hr/ml', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.'}, {'type': 'PRIMARY', 'title': 'Time to Reach Cmax (Tmax)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg; >=6 and <12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}, {'id': 'OG001', 'title': 'BeneFIX 50 IU/kg; Age Group:>=12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.500', 'groupId': 'OG000', 'lowerLimit': '0.250', 'upperLimit': '3.00'}, {'value': '0.375', 'groupId': 'OG001', 'lowerLimit': '0.250', 'upperLimit': '3.00'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'unitOfMeasure': 'hours', 'dispersionType': 'Full Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.'}, {'type': 'PRIMARY', 'title': 'Volume of Distribution at Steady State (Vss)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg; >=6 and <12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}, {'id': 'OG001', 'title': 'BeneFIX 50 IU/kg; Age Group:>=12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '227.9', 'spread': '20', 'groupId': 'OG000'}, {'value': '218.8', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.', 'unitOfMeasure': 'milliliter/kilogram (mL/kg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.'}, {'type': 'PRIMARY', 'title': 'Terminal Phase Rate Constant (Kel)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg; >=6 and <12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}, {'id': 'OG001', 'title': 'BeneFIX 50 IU/kg; Age Group:>=12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.02509', 'spread': '16', 'groupId': 'OG000'}, {'value': '0.01781', 'spread': '20', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'description': 'Linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.', 'unitOfMeasure': '1/hr', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.'}, {'type': 'PRIMARY', 'title': 'Mean Residence Time (MRT)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg; >=6 and <12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}, {'id': 'OG001', 'title': 'BeneFIX 50 IU/kg; Age Group:>=12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.78', 'spread': '14', 'groupId': 'OG000'}, {'value': '51.01', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'description': 'AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.', 'unitOfMeasure': 'hours', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.'}, {'type': 'PRIMARY', 'title': 'Plasma Decay Half-Life (t½)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg; >=6 and <12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}, {'id': 'OG001', 'title': 'BeneFIX 50 IU/kg; Age Group:>=12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.88', 'spread': '4.4903', 'groupId': 'OG000'}, {'value': '39.56', 'spread': '7.3832', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.', 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.'}, {'type': 'PRIMARY', 'title': 'Systemic Clearance (CL)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg; >=6 and <12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}, {'id': 'OG001', 'title': 'BeneFIX 50 IU/kg; Age Group:>=12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.378', 'spread': '16', 'groupId': 'OG000'}, {'value': '4.291', 'spread': '15', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body.', 'unitOfMeasure': 'mL/hr/kg', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.'}, {'type': 'PRIMARY', 'title': 'Incremental Recovery', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg; >=6 and <12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}, {'id': 'OG001', 'title': 'BeneFIX 50 IU/kg; Age Group:>=12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0.7759', 'spread': '26', 'groupId': 'OG000'}, {'value': '0.8199', 'spread': '17', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': 'Pre-dose, 0.25, 0.5 and 1 hour post-dose', 'description': 'Incremental recovery: Increase in circulating increase in FIX activity for every IU of BeneFIX administered per kg of body weight.', 'unitOfMeasure': '(IU/dL)/(IU/Kg)', 'dispersionType': 'Geometric Coefficient of Variation', 'reportingStatus': 'POSTED', 'populationDescription': 'The PK parameter analysis population was defined as all participants enrolled and treated who had at least 1 of the PK parameters of primary interest. All participants were included in the PK analysis population.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), and Withdrawals Due to Adverse Events (AE)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAE is defined as newly occurring or worsening after first dose.', 'unitOfMeasure': 'Particpants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set was defined as all participants who received at least 1 dose of BeneFIX.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Abnormal Clinical Laboratory Measurements (Without Regard to Baseline Abnormality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '12', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 96 hours post-dose (Day 5 or early termination)', 'description': 'Clinical laboratory analysis tests included hematology, serium chemistry, prothrombin time and urianalysis. Numbers of subjects with laboratory test abnormalities without regard to baseline abnormality were reported.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included All participants who received at least 1 dose of BeneFIX.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Vital Signs Post-Dose Data Met Criteria of Potential Clinical Concern (Without Regard to Baseline Abnormality)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline up to 96 hours post-dose (Day 5 or early termination)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included All participants who received at least 1 dose of BeneFIX.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Inhibitor Development', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included All participants who received at least 1 dose of BeneFIX.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Allergic Reactions', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included All participants who received at least 1 dose of BeneFIX.'}, {'type': 'SECONDARY', 'title': 'Number of Subjects With Thrombogenicity', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'BeneFIX 50 IU/kg', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis population included All participants who received at least 1 dose of BeneFIX.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'BeneFIX 50 IU/kg; Age Group: >=6 and <12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by intravenous (IV) infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}, {'id': 'FG001', 'title': 'BeneFIX 50 IU/kg; Age Group: >=12 Years', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '4'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Twelve (12) participants that were age 6 years or older (weight ≥20 kg) with moderate severe to severe hemophilia B (FIX activity ≤2%) were enrolled. Four (4) participants were at the younger age range of ≥6 and \\<12 years; remaining participants were 12 years or older.', 'preAssignmentDetails': 'Participants did not receive an infusion of any FIX products for at least 4 days and were required to be in a non-bleeding state before the administration of BeneFIX on Day 1.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '12', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'All Participants', 'description': 'Participants received a single dose of 50 IU/kg BeneFIX administered by IV infusion within 10 minutes at approximately 0800 hours (±2 hours) on Day 1.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '24.8', 'spread': '15.4', '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': '12', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}], 'populationDescription': 'All participants were included in the baseline population.'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-06-13', 'studyFirstSubmitDate': '2014-08-07', 'resultsFirstSubmitDate': '2016-05-04', 'studyFirstSubmitQcDate': '2014-08-07', 'lastUpdatePostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2016-06-13', 'studyFirstPostDateStruct': {'date': '2014-08-11', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-07-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Observed Plasma Concentration (Cmax)', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose'}, {'measure': 'Area Under the Concentration Time Curve From Time 0 to the Time of the Last Quantifiable Concentration (AUClast)', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose'}, {'measure': 'Area Under the Concentration Time Curve From Time 0 to Infinity (AUCinf)', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose'}, {'measure': 'Time to Reach Cmax (Tmax)', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose'}, {'measure': 'Volume of Distribution at Steady State (Vss)', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'description': 'Volume of distribution is defined as the theoretical volume in which the total amount of drug would need to be uniformly distributed to produce the desired blood concentration of a drug. Vss is the apparent volume of distribution at steady-state.'}, {'measure': 'Terminal Phase Rate Constant (Kel)', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'description': 'Linear regression of the log linear concentration time curve. Only those data points judged to describe the terminal log linear decline were used in the regression.'}, {'measure': 'Mean Residence Time (MRT)', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'description': 'AUMCinf/AUCinf, where AUMCinf is the area under the first moment curve from time 0 extrapolated to infinite time, calculated using the linear/log trapezoidal method.'}, {'measure': 'Plasma Decay Half-Life (t½)', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'description': 'Plasma decay half-life is the time measured for the plasma concentration to decrease by one half.'}, {'measure': 'Systemic Clearance (CL)', 'timeFrame': 'Pre-dose, 0.25, 0.5, 1, 3, 6, 9, 24, 50, 72 and 96 hours post-dose', 'description': 'CL is a quantitative measure of the rate at which a drug substance is removed from the body.'}, {'measure': 'Incremental Recovery', 'timeFrame': 'Pre-dose, 0.25, 0.5 and 1 hour post-dose', 'description': 'Incremental recovery: Increase in circulating increase in FIX activity for every IU of BeneFIX administered per kg of body weight.'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Treatment-Emergent Adverse Events (TEAE), Serious Adverse Events (SAE), and Withdrawals Due to Adverse Events (AE)', 'timeFrame': 'From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.', 'description': 'An AE was any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An SAE was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; lifethreatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. TEAE is defined as newly occurring or worsening after first dose.'}, {'measure': 'Number of Participants With Abnormal Clinical Laboratory Measurements (Without Regard to Baseline Abnormality)', 'timeFrame': 'Baseline up to 96 hours post-dose (Day 5 or early termination)', 'description': 'Clinical laboratory analysis tests included hematology, serium chemistry, prothrombin time and urianalysis. Numbers of subjects with laboratory test abnormalities without regard to baseline abnormality were reported.'}, {'measure': 'Number of Participants With Vital Signs Post-Dose Data Met Criteria of Potential Clinical Concern (Without Regard to Baseline Abnormality)', 'timeFrame': 'Baseline up to 96 hours post-dose (Day 5 or early termination)'}, {'measure': 'Number of Participants With Inhibitor Development', 'timeFrame': 'From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.'}, {'measure': 'Number of Participants With Allergic Reactions', 'timeFrame': 'From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.'}, {'measure': 'Number of Subjects With Thrombogenicity', 'timeFrame': 'From the subject provided informed consent through and including 28 calendar days after the last administration of the study drug.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Hemophilia B']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://trialinfoemail.pfizer.com/pages/landing.aspx?StudyID=B1821048&StudyName=An%20Open-Label%2C%20Single%20Dose%20Pharmacokinetic%20Study%20of%20Benefix%20%28Recombinant%20Factor%20IX%29%20in%20Male%20Chinese%20Subjects%20with%20Hemophilia%20B%20', 'label': 'To obtain contact information for a study center near you, click here.'}]}, 'descriptionModule': {'briefSummary': 'The sample size of 12 male Chinese subjects are based on the CFDA requirement for a China PK study and to support the registration in China.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male Chinese subjects 6 years or older (weight ≥20kg) with moderate to severe hemophilia B (Factor IX activity ≤2%).\n* Subjects should not have received an infusion of any Factor IX products for at least 4 days before the administration of BeneFIX on Day 1.\n* Subjects must be in a non-bleeding state before the administration of BeneFIX on Day 1.\n\nExclusion Criteria:\n\n* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing) disease or clinical findings at Screening.\n* Diagnosed with any other bleeding disorder in addition to hemophilia B.\n* Current FIX inhibitor or history of FIX inhibitor (defined as \\> Upper Limit of Normal (ULN) of the reporting lab).'}, 'identificationModule': {'nctId': 'NCT02213250', 'briefTitle': 'An Open-Label, Single Dose Pharmacokinetic Study of Benefix (Recombinant Factor IX) in Male Chinese Subjects With Hemophilia B', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pfizer'}, 'officialTitle': 'An Open-label, Single Dose Pharmacokinetic Study Of Benefix (Nonacog Alfa, Recombinant Factor Ix) In Male Chinese Subjects With Hemophilia B', 'orgStudyIdInfo': {'id': 'B1821048'}, 'secondaryIdInfos': [{'id': '2015-003027-61', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'BeneFIX', 'interventionNames': ['Drug: BENEFIX']}], 'interventions': [{'name': 'BENEFIX', 'type': 'DRUG', 'description': 'Single dose of 50 IU/kg of BeneFIX by intravenous infusion within 10 minutes.', 'armGroupLabels': ['BeneFIX']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100032', 'city': 'Beijing', 'country': 'China', 'facility': 'Peking Union Medical College Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100045', 'city': 'Beijing', 'country': 'China', 'facility': "Hematology Department,Beijing Children's Hospital, Capital Medical University", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Pfizer CT.gov Call Center', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Pfizer'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pfizer', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}