A Phase II Study Evaluating Fostamatinib for Hospitalized Adults with COVID-19.
A Phase II Study Evaluating Fostamatinib for Hospitalized Adults with COVID-19.
批准号:
10934198
负责人:
RICHARD CHILDS
金额:
$42.09万
依托单位国家:
美国
项目类别:
财政年份:
--
资助国家:
美国
项目状态:
未结题
起止时间:
至
关键词:
AdultAllogenicAnemiaAuthorization documentationCOVID-19CategoriesClinical TrialsConsentDecision MakingDiseaseEligibility DeterminationEnrollmentExclusion CriteriaHomologous TransplantationHospitalizationHumanImmuneImpaired cognitionIndividualInstitutionInstitutional Review BoardsIntubationLegalMediatingMentally Disabled PersonsPatientsPersonal SatisfactionProcessProtocols documentationRegulationResearch PersonnelResearch SubjectsSafetySedation procedureTestingThrombocytopeniaTransplantationUncertaintyVulnerable Populationsarmauthorityclinical efficacyclinically relevantcytopeniahuman subjectimprovedinclusion criteriamemberphase 2 studypost-transplant
中文摘要
点击翻译按钮获取中文摘要
英文摘要
The primary objective of this study is to evaluate the safety and early clinical efficacy of fostamatinib following allogeneic BM transplantation in patients with post transplant immune mediated cytopenias. This trial is the extension arm of the primary trial, with enrollment reserved for those responding to fostamatinib treatment on the primary trial.
Secondary objectives will be to assess clinically relevant endpoints of safety.
Subject Inclusion and Exclusion Criteria will be reviewed as appropriate by a member of the study team. If there is any uncertainty, the PI should make the decision on whether a potential subject is eligible for study enrollment.
Certain human subjects are categorized as vulnerable populations and require special treatment with respect to safeguards of their well-being. For this clinical trial, examples include cognitively impaired or mentally disabled persons and intubated individuals who are sedated. When it is determined that a potential research subject is cognitively impaired, federal and institutional regulations permit researchers to obtain consent from a legally authorized representative (LAR). The study team will obtain consent from these vulnerable subjects using an IRB-approved protocol- specific process for consent using a LAR.
期刊论文(5)
专著(0)
科研奖励(0)
会议论文
DOI:
10.3390/genes11121501
发表时间:
2020-12-13
期刊:
Genes
影响因子:
3.5
作者:
[Smith RH, Chen YC, Seifuddin F, Hupalo D, Alba C, Reger R, Tian X, Araki D, Dalgard CL, Childs RW, Pirooznia M, Larochelle A]
通讯作者:
Larochelle A
Correction: Ocular surface indicators and biomarkers in chronic ocular graft-versus-host disease: a prospective cohort study.
纠正:慢性眼移植物抗宿主病的眼表面指标和生物标志物:一项前瞻性队列研究。
DOI:
10.1038/s41409-021-01315-9
发表时间:
2021
期刊:
Bone marrow transplantation
影响因子:
4.8
作者:
[Pietraszkiewicz,AlexandraA, Payne,Debbie, Abraham,Maria, Garced,Angel, Devarasetty,KrishnaC, Wall,Megan, Menezes,SupriyaM, Ugarte,Sveti, Pirsl,Filip, Goklemez,Sencer, Ferris,FrederickL, Barrett,John, Battiwalla,Minoo, Childs,RichardW, P]
通讯作者:
P
Allogeneic Immunotherapy for cancer and nonmalignant hematological disorders
-
批准号:8344766
-
项目类别:
-
资助金额:$269.38万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic and Autologous Immunotherapy for cancer and nonmalignant hematological disorders
-
批准号:10017619
-
项目类别:
-
资助金额:$377.58万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
A Phase II Study Evaluating Fostamatinib for Hospitalized Adults with COVID-19.
-
批准号:10253913
-
项目类别:
-
资助金额:$75.96万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic and Autologous Immunotherapy for cancer and nonmalignant hematological disorders
-
批准号:9362214
-
项目类别:
-
资助金额:$271.99万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic Immunotherapy for cancer and nonmalignant hematological disorders
-
批准号:8746562
-
项目类别:
-
资助金额:$261.04万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Cyclosporine Inhalation Solution (CIS) treatment of Bronchiolitis Obliterans
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批准号:8344885
-
项目类别:
-
资助金额:$47.54万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic Immunotherapy
-
批准号:7157875
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项目类别:
-
资助金额:$0.0万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic and Autologous Immunotherapy for cancer and nonmalignant hematological disorders
-
批准号:8939772
-
项目类别:
-
资助金额:$276.74万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic Immunotherapy for cancer and nonmalignant hematological disorders
-
批准号:7969034
-
项目类别:
-
资助金额:$296.18万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic Immunotherapy for cancer and nonmalignant hem
-
批准号:7321313
-
项目类别:
-
资助金额:$0.0万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic Immunotherapy for cancer and nonmalignant hematological disorders
-
批准号:8557917
-
项目类别:
-
资助金额:$260.95万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic Immunotherapy for cancer and nonmalignant hematological disorders
-
批准号:7734975
-
项目类别:
-
资助金额:$307.53万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic Immunotherapy for cancer and nonmalignant hematological disorders
-
批准号:8149488
-
项目类别:
-
资助金额:$291.51万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic and Autologous Immunotherapy for cancer and nonmalignant hematological disorders
-
批准号:10492970
-
项目类别:
-
资助金额:$157.1万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
A Phase II Study Evaluating Fostamatinib for Hospitalized Adults with COVID-19.
-
批准号:10492972
-
项目类别:
-
资助金额:$39.27万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Cyclosporine Inhalation Solution (CIS) treatment of Bronchiolitis Obliterans
-
批准号:8558030
-
项目类别:
-
资助金额:$46.05万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic Immunotherapy
-
批准号:6966961
-
项目类别:
-
资助金额:$0.0万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic Immunotherapy
-
批准号:6818008
-
项目类别:
-
资助金额:$0.0万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
A Phase II Study Evaluating Fostamatinib for Hospitalized Adults with COVID-19.
-
批准号:10706187
-
项目类别:
-
资助金额:$82.92万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
Allogeneic and Autologous Immunotherapy for cancer and nonmalignant hematological disorders
-
批准号:10706163
-
项目类别:
-
资助金额:$326.42万
-
财政年份:--
-
负责人:RICHARD CHILDS
-
依托单位:
海外基金