NL-OMON52775招募中3 期
The Effect of Voxelotor on Cerebral Perfusion and Oxygenation (ESR-C005) - COVERAGE
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Documented severe SCD genotype (HbSS, HbS-β) which must be based on
- •previous or confirmed by high performance liquid chromatography (HPLC) testing
- •during screening.
- •2. Age 18 and above
- •3. Hemoglobin (Hb) <=10.5 g/dL
- •4. For participants taking hydroxyurea (HU), the dose of HU (mg/kg) must be
- •stable for at
- •least 90 days prior to participation and with no anticipated need for dose
- •adjustments
- •5. Participants, who if female and of child bearing potential, are using
- •highly effective
- •methods of contraception from study start to 30 days after the last dose of
- •study drug, and who if male are willing to use barrier methods of
- •contraception, from study start to 30
- •days after the last dose of study drug.
- •6. Participant has provided documented informed consent or assent (the
- •informed consent
- •form [ICF] must be reviewed and signed by each participant; the participant*s
- •legal representative or legal guardian, and the participant*s assent must be
- •7. For extension phase: clinical benefit being apparent, clinical benefit is
- •defined as an increase in Hb of > 0.62 mmol/L (1 g/dL) and or clinical response
- •assessed by the investigator or reported by patient (e.g. increased endurance,
- •diminished fatigue, improved well-being).
排除标准
- •1. No informed consent has been given
- •2. Contra-indication for MRI or acetazolamide
- •3. Female who is breast feeding or pregnant.
- •4. Patients who are receiving regularly scheduled blood (RBC) transfusion
- •therapy (also
- •termed chronic, prophylactic, or preventive transfusion) or have received a RBC
- •transfusion for any reason within 90 days before participation.
- •5. Hospitalized for sickle cell crisis or other vaso-occlusive event within 14
- •days prior participation.
- •6. Hepatic dysfunction characterized by alanine aminotransferase (ALT) >4 ×
- •7. Participants with clinically significant bacterial, fungal, parasitic or
- •viral infection which
- •require therapy:
- •Participants with acute bacterial infection requiring antibiotic use should
- •screening/enrollment until the course of antibiotic therapy has been
- •Participants with known active hepatitis A, B, or C or who are known to be
- •human immunodeficiency virus (HIV) positive.
- •8. Severe renal dysfunction (estimated glomerular filtration rate <30mL/min).
- •9. History of malignancy within the past 2 years prior to participation
- •requiring chemotherapy and/or radiation (with the exception of local therapy
- •for non-melanoma
- •skin malignancy).
- •10. History of unstable or deteriorating cardiac or pulmonary disease within 6
- •months prior
- •to consent including but not limited to the following:
- •Unstable angina pectoris or myocardial infarction or elective coronary
- •intervention.
- •Congestive heart failure requiring hospitalization.
- •Uncontrolled clinically significant arrhythmias.
- •11. Any condition affecting drug absorption, such as major surgery involving
- •the stomach or
- •small intestine (prior cholecystectomy is acceptable).
- •12. Participated in another clinical trial of an investigational agent (or
- •medical device) within
- •30 days or 5 half-lives of date of informed consent, whichever is longer, or is
- •participating in another trial of an investigational agent (or medical device)
- •13. Medical, psychological, or behavioral conditions, which, in the opinion of
- •Investigator, may preclude safe participation, confound study interpretation,
- •with compliance, or preclude informed consent.
- •14. Receipt of erythropoietin or other hematopoietic growth factors within 28
- •days of signing
- •ICF or anticipated need for such agents during the study.
研究者
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