PULSE ARGININE BUTYRATE IN SICKLE CELL DISEASE
脉冲精氨酸丁酸盐治疗镰状细胞病
基本信息
- 批准号:7606231
- 负责人:
- 金额:$ 2.36万
- 依托单位:
- 依托单位国家:美国
- 项目类别:
- 财政年份:2007
- 资助国家:美国
- 起止时间:2007-01-03 至 2007-11-30
- 项目状态:已结题
- 来源:
- 关键词:Arginine ButyrateClinicalComputer Retrieval of Information on Scientific Projects DatabaseCross-Over StudiesEventFundingGrantInstitutionLabelPatientsPhasePhase III Clinical TrialsPhysiologic pulsePulse takingRateResearchResearch PersonnelResolutionResourcesSickle Cell AnemiaSourceSymptomsTestingUnited States Food and Drug AdministrationUnited States National Institutes of Healthbasedaytherapy design
项目摘要
This subproject is one of many research subprojects utilizing the
resources provided by a Center grant funded by NIH/NCRR. The subproject and
investigator (PI) may have received primary funding from another NIH source,
and thus could be represented in other CRISP entries. The institution listed is
for the Center, which is not necessarily the institution for the investigator.
This open-label Phase II cross-over study will test hypotheses that 1) Pulsed AB will induce higher levels of Hb F than HU alone, and 2) assessment of factors influencing erythropoietic rates may identify patient subsets who are more likely to respond to HU + AB. The study is open only to patients who have not had resolution of their symptoms with HU alone, and have a baseline Hb F of at least 2%. Patients will serve as their own controls. Clinical events and hematologic factors will be assessed in patients on HU alone for 6 months. AB therapy will then be added, (4 days, once/ month), and Hb F parameters and clinical events will be assessed on combined therapy. If additive effects are found with the two agents, the trial may provide a basis for selecting patients most likely to benefit from AB (in addition to HU therapy) and for design of Phase III trials. (This small trial will not serve as a pivotal trial for FDA approval of AB for treatment of sickle cell disease.)
这个子项目是众多研究子项目之一
项目成果
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