{"id":"https://openalex.org/W3109957129","doi":"https://doi.org/10.24110/0031-403x-2020-99-6-190-198","title":"RESULTS OF AN OPEN, PROSPECTIVE, MULTICENTER, NONCOMPARATIVE STUDY OF THE PHARMACOKINETICS, EFFICACY AND SAFETY OF NONACOG ALFA IN PATIENTS AGED 6\u201312 YEARS WITH SEVERE AND MODERATE HEMOPHILIA B","display_name":"RESULTS OF AN OPEN, PROSPECTIVE, MULTICENTER, NONCOMPARATIVE STUDY OF THE PHARMACOKINETICS, EFFICACY AND SAFETY OF NONACOG ALFA IN PATIENTS AGED 6\u201312 YEARS WITH SEVERE AND MODERATE HEMOPHILIA B","publication_year":2020,"publication_date":"2020-11-27","ids":{"openalex":"https://openalex.org/W3109957129","doi":"https://doi.org/10.24110/0031-403x-2020-99-6-190-198","mag":"3109957129"},"language":"en","primary_location":{"id":"doi:10.24110/0031-403x-2020-99-6-190-198","doi":"https://doi.org/10.24110/0031-403x-2020-99-6-190-198","is_oa":true,"landing_page_url":"https://doi.org/10.24110/0031-403x-2020-99-6-190-198","pdf_url":null,"source":{"id":"https://openalex.org/S4210181920","display_name":"PEDIATRIA Journal named after G N SPERANSKY","issn_l":"0031-403X","issn":["0031-403X","1990-2182"],"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":["poland-20","russia-white-list-1"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pediatria. Journal named after G.N. Speransky","raw_type":"journal-article"},"volume":null,"type":"article","is_traditional":true,"indexed_in":["crossref"],"open_access":{"is_oa":true,"oa_status":"hybrid","oa_url":"https://doi.org/10.24110/0031-403x-2020-99-6-190-198","any_repository_has_fulltext":false},"authorships":[{"author_position":"first","author":{"id":"https://openalex.org/A5056998708","display_name":"T. A. Andreeva","orcid":"https://orcid.org/0000-0002-5649-325X","observed_orcids":["https://orcid.org/0000-0002-5649-325X"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"T.A. Andreeva","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0002-5649-325X","affiliations":[]},{"author_position":"middle","author":{"id":null,"display_name":"V.V. Lebedev","orcid":"https://orcid.org/0000-0001-6934-2349","observed_orcids":["https://orcid.org/0000-0001-6934-2349"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"V.V. Lebedev","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0001-6934-2349","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5082739960","display_name":"Vladim\u00edr Vdovin","orcid":"https://orcid.org/0000-0001-6616-4604","observed_orcids":["https://orcid.org/0000-0001-6616-4604","https://orcid.org/0000-0002-5723-0574"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"V.V. Vdovin","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0001-6616-4604","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5047257964","display_name":"Margarita Arkadevna Timofeeva","orcid":"https://orcid.org/0000-0003-4046-5593","observed_orcids":["https://orcid.org/0000-0003-4046-5593"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"M.A. Timofeeva","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0003-4046-5593","affiliations":[]},{"author_position":"middle","author":{"id":null,"display_name":"I.L. Davydkin","orcid":"https://orcid.org/0000-0003-0645-7645","observed_orcids":["https://orcid.org/0000-0003-0645-7645"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"I.L. Davydkin","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0003-0645-7645","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5004678604","display_name":"\u0418. \u0410. \u041b\u0430\u0432\u0440\u0438\u0447\u0435\u043d\u043a\u043e","orcid":"https://orcid.org/0000-0002-1483-7704","observed_orcids":["https://orcid.org/0000-0002-1483-7704"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"I.A. Lavrichenko","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0002-1483-7704","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5074134604","display_name":"O.A. Krasheninnikova","orcid":"https://orcid.org/0000-0002-7431-9546","observed_orcids":["https://orcid.org/0000-0002-7431-9546"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"O.A. Krasheninnikova","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0002-7431-9546","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5061995131","display_name":"T.V. Asekretova","orcid":"https://orcid.org/0000-0002-1246-5898","observed_orcids":["https://orcid.org/0000-0002-1246-5898"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"T.V. Asekretova","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0002-1246-5898","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5086858573","display_name":"Pavel Svirin","orcid":"https://orcid.org/0000-0002-8461-6077","observed_orcids":["https://orcid.org/0000-0002-8461-6077"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"P.V. Svirin","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0002-8461-6077","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5030602291","display_name":"V.Yu. Petrov","orcid":"https://orcid.org/0000-0002-4583-1137","observed_orcids":["https://orcid.org/0000-0002-4583-1137"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"V.Yu. Petrov","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0002-4583-1137","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5011537298","display_name":"\u0418. \u0412. \u041a\u0443\u0440\u0442\u043e\u0432","orcid":"https://orcid.org/0000-0003-0420-5735","observed_orcids":["https://orcid.org/0000-0003-0420-5735"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"I.V. Kurtov","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0003-0420-5735","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5084227320","display_name":"E.E. Shiller","orcid":"https://orcid.org/0000-0003-0434-6474","observed_orcids":["https://orcid.org/0000-0003-0434-6474"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"E.E. Shiller","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0003-0434-6474","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5046307144","display_name":"\u0418.\u0421. \u0422\u0430\u0440\u0430\u0441\u043e\u0432\u0430","orcid":"https://orcid.org/0000-0003-0402-4774","observed_orcids":["https://orcid.org/0000-0003-0402-4774"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"I.S. Tarasova","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0003-0402-4774","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5001572944","display_name":"Dmitry Anatolievich Kudlay","orcid":"https://orcid.org/0000-0003-1878-4467","observed_orcids":["https://orcid.org/0000-0003-1878-4467"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"D.A. Kudlay","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0003-1878-4467","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5036222383","display_name":"Elena V. Gapchenko","orcid":"https://orcid.org/0000-0002-6817-5531","observed_orcids":["https://orcid.org/0000-0002-6817-5531"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"E.V. Gapchenko","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0002-6817-5531","affiliations":[]},{"author_position":"middle","author":{"id":"https://openalex.org/A5035417997","display_name":"\u041e. \u0410. Markova","orcid":"https://orcid.org/0000-0002-1179-3881","observed_orcids":["https://orcid.org/0000-0002-1179-3881"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"O.A. Markova","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0002-1179-3881","affiliations":[]},{"author_position":"last","author":{"id":"https://openalex.org/A5069705379","display_name":"A.Yu. Borozinets","orcid":"https://orcid.org/0000-0002-4863-8471","observed_orcids":["https://orcid.org/0000-0002-4863-8471"]},"institutions":[],"countries":[],"is_corresponding":false,"raw_author_name":"A.Yu. Borozinets","raw_affiliation_strings":[],"raw_orcid":"https://orcid.org/0000-0002-4863-8471","affiliations":[]}],"institutions":[],"countries_distinct_count":0,"institutions_distinct_count":0,"corresponding_author_ids":[],"corresponding_institution_ids":[],"apc_list":null,"apc_paid":null,"fwci":0.0,"has_fulltext":false,"cited_by_count":0,"citation_normalized_percentile":{"value":0.0,"is_in_top_1_percent":false,"is_in_top_10_percent":false},"cited_by_percentile_year":null,"biblio":{"volume":"99","issue":"6","first_page":"190","last_page":"198"},"is_retracted":false,"is_paratext":false,"is_xpac":false,"primary_topic":{"id":"https://openalex.org/T11280","display_name":"Hemophilia Treatment and Research","score":1.0,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},"topics":[{"id":"https://openalex.org/T11280","display_name":"Hemophilia Treatment and Research","score":1.0,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T10746","display_name":"Platelet Disorders and Treatments","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}},{"id":"https://openalex.org/T11917","display_name":"Coagulation, Bradykinin, Polyphosphates, and Angioedema","score":0.0,"subfield":{"id":"https://openalex.org/subfields/2720","display_name":"Hematology"},"field":{"id":"https://openalex.org/fields/27","display_name":"Medicine"},"domain":{"id":"https://openalex.org/domains/4","display_name":"Health Sciences"}}],"keywords":[{"id":"https://openalex.org/keywords/recombinant-factor-ix","display_name":"recombinant factor IX","score":0.9789999723434448},{"id":"https://openalex.org/keywords/hemophilia-b","display_name":"hemophilia B","score":0.9919999837875366},{"id":"https://openalex.org/keywords/pediatric-patients","display_name":"pediatric patients","score":0.7770000100135803},{"id":"https://openalex.org/keywords/pharmacokinetics","display_name":"pharmacokinetics","score":0.921999990940094},{"id":"https://openalex.org/keywords/prophylaxis","display_name":"prophylaxis","score":0.9089999794960022},{"id":"https://openalex.org/keywords/bleeding-events","display_name":"bleeding events","score":0.6539999842643738},{"id":"https://openalex.org/keywords/factor-ix-activity","display_name":"factor IX activity","score":0.6510000228881836},{"id":"https://openalex.org/keywords/drug-safety","display_name":"drug safety","score":0.527999997138977},{"id":"https://openalex.org/keywords/biological-half-life","display_name":"biological half-life","score":0.546999990940094},{"id":"https://openalex.org/keywords/auc","display_name":"AUC","score":0.4959999918937683},{"id":"https://openalex.org/keywords/spontaneous-hemorrhage","display_name":"spontaneous hemorrhage","score":0.6940000057220459},{"id":"https://openalex.org/keywords/post-traumatic-bleeding","display_name":"post-traumatic bleeding","score":0.8600000143051147},{"id":"https://openalex.org/keywords/treatment-efficacy","display_name":"treatment efficacy","score":0.32899999618530273},{"id":"https://openalex.org/keywords/adverse-events","display_name":"adverse events","score":0.4659999907016754}],"concepts":[{"id":"https://openalex.org/C71924100","wikidata":"https://www.wikidata.org/wiki/Q11190","display_name":"Medicine","level":0,"score":0.9372200965881348},{"id":"https://openalex.org/C112705442","wikidata":"https://www.wikidata.org/wiki/Q323936","display_name":"Pharmacokinetics","level":2,"score":0.7593410015106201},{"id":"https://openalex.org/C2781221834","wikidata":"https://www.wikidata.org/wiki/Q425360","display_name":"Factor IX","level":2,"score":0.5075989961624146},{"id":"https://openalex.org/C188816634","wikidata":"https://www.wikidata.org/wiki/Q2113324","display_name":"Prospective cohort study","level":2,"score":0.49240338802337646},{"id":"https://openalex.org/C2992435398","wikidata":"https://www.wikidata.org/wiki/Q6934595","display_name":"Multicenter study","level":3,"score":0.4845978021621704},{"id":"https://openalex.org/C126322002","wikidata":"https://www.wikidata.org/wiki/Q11180","display_name":"Internal medicine","level":1,"score":0.40628743171691895},{"id":"https://openalex.org/C90924648","wikidata":"https://www.wikidata.org/wiki/Q120569","display_name":"Gastroenterology","level":1,"score":0.3429264426231384},{"id":"https://openalex.org/C187212893","wikidata":"https://www.wikidata.org/wiki/Q123028","display_name":"Pediatrics","level":1,"score":0.3308882713317871},{"id":"https://openalex.org/C168563851","wikidata":"https://www.wikidata.org/wiki/Q1436668","display_name":"Randomized controlled trial","level":2,"score":0.1396772563457489}],"mesh":[],"locations_count":1,"locations":[{"id":"doi:10.24110/0031-403x-2020-99-6-190-198","doi":"https://doi.org/10.24110/0031-403x-2020-99-6-190-198","is_oa":true,"landing_page_url":"https://doi.org/10.24110/0031-403x-2020-99-6-190-198","pdf_url":null,"source":{"id":"https://openalex.org/S4210181920","display_name":"PEDIATRIA Journal named after G N SPERANSKY","issn_l":"0031-403X","issn":["0031-403X","1990-2182"],"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":["poland-20","russia-white-list-1"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pediatria. Journal named after G.N. Speransky","raw_type":"journal-article"}],"best_oa_location":{"id":"doi:10.24110/0031-403x-2020-99-6-190-198","doi":"https://doi.org/10.24110/0031-403x-2020-99-6-190-198","is_oa":true,"landing_page_url":"https://doi.org/10.24110/0031-403x-2020-99-6-190-198","pdf_url":null,"source":{"id":"https://openalex.org/S4210181920","display_name":"PEDIATRIA Journal named after G N SPERANSKY","issn_l":"0031-403X","issn":["0031-403X","1990-2182"],"is_oa":false,"is_in_doaj":false,"is_core":false,"listed_in":["poland-20","russia-white-list-1"],"host_organization":null,"host_organization_name":null,"host_organization_lineage":[],"host_organization_lineage_names":[],"type":"journal"},"license":"cc-by","license_id":"https://openalex.org/licenses/cc-by","version":"publishedVersion","is_accepted":true,"is_published":true,"raw_source_name":"Pediatria. Journal named after G.N. Speransky","raw_type":"journal-article"},"sustainable_development_goals":[{"id":"https://metadata.un.org/sdg/3","display_name":"Good health and well-being","score":1.0}],"study_designs":[{"id":"https://openalex.org/study-designs/clinical-trial","display_name":"Clinical Trial"}],"awards":[],"funders":[],"has_content":{"pdf":false,"grobid_xml":false},"content_urls":null,"referenced_works_count":0,"referenced_works":[],"related_works":["https://openalex.org/W4207046488","https://openalex.org/W2563933912","https://openalex.org/W2593592513","https://openalex.org/W2296064331","https://openalex.org/W2557473898","https://openalex.org/W4296989657","https://openalex.org/W2241150060","https://openalex.org/W4310276161","https://openalex.org/W2953660755","https://openalex.org/W4223965792"],"abstract_inverted_index":{"Providing":[0],"hemophilia":[1,61,95,370,450],"patients":[2,49,83,270,280,372,440],"with":[3,57,89,160,179,204,271,373,446],"blood":[4],"coagulation":[5],"preparations":[6],"is":[7],"one":[8,347],"of":[9,13,55,64,79,94,106,109,123,125,136,142,153,163,170,244,256,258,285,308,334,349,353,356,364,369,377,427,437],"the":[10,14,21,126,134,171,192,198,248,276,286,323,332,335,362,365,367,384,420],"priority":[11],"tasks":[12],"national":[15],"health":[16],"care":[17],"system.":[18],"In":[19],"2011,":[20],"first":[22],"recombinant":[23],"factor":[24],"IX":[25],"was":[26,37,72,131,210,220,252,273,313,359,381],"created":[27],"in":[28,47,81,133,197,269,392,439],"Russia":[29],"(rFIX,":[30],"nonacog":[31,357],"alpha,":[32],"Innonafactor,":[33,288],"GENERIUM":[34],"JSC),":[35],"that":[36,261],"previously":[38],"studied":[39,127,172,336],"for":[40,146,294,310,316,430,434],"pharmacokinetic":[41],"(PK)":[42],"parameters,":[43],"efficacy":[44,76,424],"and":[45,50,59,77,91,112,203,212,236,296,404,413,425,433,448],"safety":[46,78,426],"adult":[48],"adolescents":[51],"over":[52,247],"12":[53,82,87,444],"years":[54,88,445],"age":[56],"severe":[58,90,447],"moderate":[60,92,449],"B.":[62,451],"Objective":[63],"this":[65],"open-label,":[66],"prospective,":[67],"multicenter,":[68],"noncomparative":[69],"clinical":[70],"study":[71,74,103,135,278,401,408],"to":[73,86,177,183,207,300,443],"PK,":[75],"Innonafactor":[80,267,309],"aged":[84,441],"6":[85,442],"forms":[93],"B":[96,371],"(FIX":[97],"activity":[98,175,376],"less":[99,119],"than":[100,120],"2%).":[101],"The":[102,189],"included":[104],"periods":[105],"screening,":[107],"studies":[108],"PK":[110,137],"parameters":[111,138],"treatment":[113,148,225,312,318,432,436],"within":[114,263],"26\u00b11":[115],"weeks,":[116],"but":[117],"not":[118,400,406,417],"50":[121],"days":[122],"administration":[124,169,268,333,355],"drug.":[128],"Nonacog":[129],"alfa":[130,358],"administered":[132,293],"at":[139,150],"a":[140,151,158,180],"dose":[141,152,307],"75":[143],"IU/kg,":[144,155,315],"once,":[145],"prophylactic":[147,311,431],"\u2013":[149,319],"45\u00b110":[154],"2":[156],"times":[157],"week":[159],"an":[161,351],"interval":[162],"72\u201396":[164],"h.":[165],"30":[166],"minutes":[167],"after":[168,187,266],"drug,":[173],"FIX":[174,375],"increased":[176],"73,93\u00b113,35%,":[178],"gradual":[181],"decrease":[182],"5,88\u00b11,97%":[184],"72":[185,264],"hours":[186,265],"administration.":[188],"area":[190],"under":[191],"\u00abconcentration":[193],"\u2012":[194],"time\u00bb":[195],"curve":[196],"section":[199],"0\u201372":[200],"h":[201],"(AUC0\u201372)":[202],"exponential":[205],"extrapolation":[206],"infinity":[208],"(AUC00\u2012\u221e)":[209],"1573,41\u00b1407,16%*h":[211],"1808,74":[213],"\u00b1":[214],"437,59%*h":[215],"respectively.":[216],"Biological":[217],"half-life":[218],"(T1/2)":[219],"28,11\u00b18,60":[221],"hours.":[222],"During":[223,275,383],"preventive":[224],"there":[226],"were":[227,234,240,292,390,399,416],"19":[228,324],"hemorrhagic":[229],"episodes,":[230,327],"14":[231,328,386],"(74%)":[232],"bleedings":[233,239,340],"post-traumatic":[235],"5":[237,338],"(26%)":[238],"spontaneous.":[241],"Mean":[242,254,305],"number":[243,255],"bleeding":[245,260,272,302,326,438],"episodes":[246,257,330],"entire":[249,277],"observation":[250],"period":[251],"1,9\u00b11,4.":[253],"spontaneous":[259],"occurred":[262],"2,5\u00b12,1.":[274],"period,":[279],"received":[281],"942,5":[282],"thousand":[283,290,298],"IU":[284,291,299],"drug":[287,402,409],"890,5":[289],"prophylaxis":[295],"52":[297],"stop":[301,346],"on":[303,342],"demand.":[304],"single":[306],"46,24\u00b15,86":[314],"on-demand":[317,435],"49\u00b113,1":[320],"IU/kg.":[321],"Of":[322],"registered":[325,391],"(73.7%)":[329],"required":[331],"drug;":[337],"(26,3%)":[339],"stopped":[341],"their":[343],"own.":[344],"To":[345],"episode":[348],"bleeding,":[350],"average":[352],"2,3\u00b12,3":[354],"required.":[360],"At":[361],"end":[363],"study,":[366,385],"proportion":[368],"residual":[374],"2%":[378],"or":[379],"more":[380],"92%.":[382],"adverse":[387],"events":[388],"(AEs)":[389],"7":[393],"(58,3%)":[394],"patients.":[395],"All":[396],"reported":[397],"AEs":[398],"related":[403],"did":[405],"require":[407],"withdrawal.":[410],"Thromboembolic":[411],"complications":[412],"immunogenic":[414],"reactions":[415],"registered.":[418],"Thus,":[419],"data":[421],"obtained":[422],"indicate":[423],"Innafactor":[428],"both":[429]},"counts_by_year":[],"updated_date":"2026-11-04T10:54:05.112534","created_date":"2020-12-07T00:00:00"}
