Matches in SemOpenAlex for { <https://semopenalex.org/work/W4309164077> ?p ?o ?g. }
Showing items 1 to 98 of
98
with 100 items per page.
- W4309164077 endingPage "567" @default.
- W4309164077 startingPage "557" @default.
- W4309164077 abstract "To assess the efficacy, pharmacokinetics, and safety of a new, highly purified 10% IVIg (BT595, Yimmugo®) administered in children with PID.This was an open-label, prospective, uncontrolled, multicenter Phase III pivotal trial. Among the 67 subjects in the trial were 18 pediatric patients aged 2 to 17 years with diagnosis of PID included in this analysis. They received doses between 0.2 and 0.8 g/kg body weight for approximately 12 months at intervals of either 3 or 4 weeks. Dosage and dosing interval were based on each patient's pre-trial infusion schedule. The rates of acute serious bacterial infections (SBI), secondary efficacy, safety, and pharmacokinetic outcomes were evaluated.No SBI occurred in the pediatric population. Two hundred sixty infusions were administered to the 18 pediatric patients. The mean (SD) IgG trough level was 8.55 (1.67) g/L at baseline and 8.84 (2.17) g/L at the follow-up visit after the last BT595 infusion. At the single infusions respectively, the average mean IgG trough levels ranged between 8.52 and 10.58 g/L. More than 85% of all infusions administered were not associated with any infusional AE (start during or within 72 h post-infusion). None of the severe or serious AEs were related to the investigational medicinal product (IMP). No premedication was used. Thirteen children reached a maximum infusion rate between > 2.0 and 8 mL/kg/h; no AE with an onset during the infusion occurred at these infusion rates.BT595 is effective, convenient, well tolerated, and safe for the treatment of children with PID.EudraCT: 2015-003652-52; NCT02810444, registered June 23, 2016." @default.
- W4309164077 created "2022-11-24" @default.
- W4309164077 creator A5001365525 @default.
- W4309164077 creator A5002831959 @default.
- W4309164077 creator A5016586425 @default.
- W4309164077 creator A5033886272 @default.
- W4309164077 creator A5046380497 @default.
- W4309164077 creator A5046607428 @default.
- W4309164077 creator A5050816060 @default.
- W4309164077 creator A5051303107 @default.
- W4309164077 creator A5059929801 @default.
- W4309164077 creator A5064322508 @default.
- W4309164077 creator A5068501157 @default.
- W4309164077 creator A5069435169 @default.
- W4309164077 creator A5087817585 @default.
- W4309164077 date "2022-11-16" @default.
- W4309164077 modified "2023-09-26" @default.
- W4309164077 title "BT595, a 10% Human Normal Immunoglobulin, for Replacement Therapy of Primary Immunodeficiency Disease: Results of a Subcohort Analysis in Children" @default.
- W4309164077 cites W1487079135 @default.
- W4309164077 cites W2038413203 @default.
- W4309164077 cites W2050878694 @default.
- W4309164077 cites W2117733065 @default.
- W4309164077 cites W2155321107 @default.
- W4309164077 cites W2205267085 @default.
- W4309164077 cites W2415340552 @default.
- W4309164077 cites W2572233504 @default.
- W4309164077 cites W2886884946 @default.
- W4309164077 cites W2915485429 @default.
- W4309164077 cites W2928734528 @default.
- W4309164077 cites W2973382248 @default.
- W4309164077 cites W3000301584 @default.
- W4309164077 cites W3036554005 @default.
- W4309164077 cites W4292432133 @default.
- W4309164077 doi "https://doi.org/10.1007/s10875-022-01397-0" @default.
- W4309164077 hasPubMedId "https://pubmed.ncbi.nlm.nih.gov/36383294" @default.
- W4309164077 hasPublicationYear "2022" @default.
- W4309164077 type Work @default.
- W4309164077 citedByCount "1" @default.
- W4309164077 countsByYear W43091640772023 @default.
- W4309164077 crossrefType "journal-article" @default.
- W4309164077 hasAuthorship W4309164077A5001365525 @default.
- W4309164077 hasAuthorship W4309164077A5002831959 @default.
- W4309164077 hasAuthorship W4309164077A5016586425 @default.
- W4309164077 hasAuthorship W4309164077A5033886272 @default.
- W4309164077 hasAuthorship W4309164077A5046380497 @default.
- W4309164077 hasAuthorship W4309164077A5046607428 @default.
- W4309164077 hasAuthorship W4309164077A5050816060 @default.
- W4309164077 hasAuthorship W4309164077A5051303107 @default.
- W4309164077 hasAuthorship W4309164077A5059929801 @default.
- W4309164077 hasAuthorship W4309164077A5064322508 @default.
- W4309164077 hasAuthorship W4309164077A5068501157 @default.
- W4309164077 hasAuthorship W4309164077A5069435169 @default.
- W4309164077 hasAuthorship W4309164077A5087817585 @default.
- W4309164077 hasBestOaLocation W43091640771 @default.
- W4309164077 hasConcept C112705442 @default.
- W4309164077 hasConcept C126322002 @default.
- W4309164077 hasConcept C187212893 @default.
- W4309164077 hasConcept C197934379 @default.
- W4309164077 hasConcept C2777288759 @default.
- W4309164077 hasConcept C2779019163 @default.
- W4309164077 hasConcept C2779134260 @default.
- W4309164077 hasConcept C2908647359 @default.
- W4309164077 hasConcept C44249647 @default.
- W4309164077 hasConcept C71924100 @default.
- W4309164077 hasConcept C99454951 @default.
- W4309164077 hasConceptScore W4309164077C112705442 @default.
- W4309164077 hasConceptScore W4309164077C126322002 @default.
- W4309164077 hasConceptScore W4309164077C187212893 @default.
- W4309164077 hasConceptScore W4309164077C197934379 @default.
- W4309164077 hasConceptScore W4309164077C2777288759 @default.
- W4309164077 hasConceptScore W4309164077C2779019163 @default.
- W4309164077 hasConceptScore W4309164077C2779134260 @default.
- W4309164077 hasConceptScore W4309164077C2908647359 @default.
- W4309164077 hasConceptScore W4309164077C44249647 @default.
- W4309164077 hasConceptScore W4309164077C71924100 @default.
- W4309164077 hasConceptScore W4309164077C99454951 @default.
- W4309164077 hasIssue "3" @default.
- W4309164077 hasLocation W43091640771 @default.
- W4309164077 hasLocation W43091640772 @default.
- W4309164077 hasLocation W43091640773 @default.
- W4309164077 hasOpenAccess W4309164077 @default.
- W4309164077 hasPrimaryLocation W43091640771 @default.
- W4309164077 hasRelatedWork W1964391114 @default.
- W4309164077 hasRelatedWork W1990335353 @default.
- W4309164077 hasRelatedWork W2028521696 @default.
- W4309164077 hasRelatedWork W2051764329 @default.
- W4309164077 hasRelatedWork W2065005216 @default.
- W4309164077 hasRelatedWork W2089699421 @default.
- W4309164077 hasRelatedWork W2154372624 @default.
- W4309164077 hasRelatedWork W2377624422 @default.
- W4309164077 hasRelatedWork W2803203200 @default.
- W4309164077 hasRelatedWork W3151787567 @default.
- W4309164077 hasVolume "43" @default.
- W4309164077 isParatext "false" @default.
- W4309164077 isRetracted "false" @default.
- W4309164077 workType "article" @default.