ISRCTN89975936进行中（未招募）1 期
A phase Ib randomized, placebo-controlled study evaluating the safety, pharmacokinetics, pharmacodynamics, and efficacy of crovalimab for the management of acute uncomplicated vaso-occlusive episodes (VOE) in patients with sickle cell disease (SCD)
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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
- 性别
- All
入选标准
- •Current inclusion criteria as of 09/02/2023:
- •1. Age >=12 to =<55 years
- •2. Body weight >=40 kg
- •3. Confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSß0 (SCD genotype of sickle cell beta zero thalassemia)
- •4. Vaccination against Neisseria meningitidis
- •5. Vaccinations against H. influenzae type B and S. pneumoniae
- •6. Participants vaccinated against SARS-CoV-2 are eligible, as long as it has been 3 days or more after inoculation with the vaccine.
- •7. Diagnosis of an acute uncomplicated VOE, that requires admission to a hospital/acute medical facility and treatment with parenteral opioid analgesics
- •8. Adequate hepatic and renal function
- •9. Hemoglobin >=5 grams/deciliter (g/dL)
- •10. Platelet count >=100,000/microliter (µL)
- •11. Participants receiving sickle cell therapies must be on a stable dose for >=28 days
- •12. For female patients of childbearing potential, an agreement to remain abstinent or use contraception for 6 months after the dose of study treatment
- •Previous inclusion criteria:
- •1. Signed ICF or Assent Form (as determined by patient’s age and individual site and country standards)
- •2. Age >=12 to =<55 years
- •3. Body weight >=40 kg
- •4. Confirmed diagnosis of HbSS (SCD genotype of sickle cell anemia) or HbSß0 (SCD genotype of sickle cell beta zero thalassemia)
- •5. Vaccination against Neisseria meningitidis
- •6. Vaccinations against H. influenzae type B and S. pneumoniae
- •7. Diagnosis of an acute uncomplicated VOE, that requires admission to a hospital/acute medical facility and treatment with parenteral opioid analgesics
- •8. Adequate hepatic and renal function
- •9. Hemoglobin >=5 g/dL
- •10. Platelet count >=100,000/µL
- •11. Patients receiving sickle cell therapies must be on a stable dose for >=28 days
- •12. For female patients of childbearing potential, an agreement to remain abstinent or use contraception for 6 months after the dose of study treatment
排除标准
- •Current exclusion criteria as of 09/02/2023:
- •1. More than 10 VOEs within the last 12 months prior to presentation, that have required a medical facility visit
- •2. Pain related to the current VOE ongoing for >48 hours
- •3. Acute pain related to avascular necrosis, hepatic or splenic sequestration, or priapism
- •4. Pain atypical of an acute uncomplicated VOE
- •5. Evidence of or suspicion of ACS
- •6. Evidence or high suspicion of a severe systemic infection
- •7. Major surgery and/or hospitalization for any reason within 30 days
- •8. History of Neisseria meningitidis infection within 6 months prior
- •9. Known HIV infection with a documented CD4 count <200 cells/µL
- •10. Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol
- •11. Immunized with a live attenuated vaccine within 30 days
- •12. History of hematopoietic stem cell transplant
- •13. Known or suspected hereditary complement deficiency
- •14. Pregnant or breastfeeding, or intending to become pregnant during the study or within 322 days (approximately 10.5 months) after the study drug administration.
- •15. Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within the prior 28 days or within five half-lives of that investigational product, whichever was greater
- •Previous exclusion criteria:
- •1. More than 10 VOEs within the last 12 months prior to presentation, that have required a medical facility visit
- •2. Pain related to the current VOE ongoing for >48 hours
- •3. Acute pain related to avascular necrosis, hepatic or splenic sequestration, or priapism
- •4. Pain atypical of an acute uncomplicated VOE
- •5. Evidence of or suspicion of ACS
- •6. Evidence or high suspicion of a severe systemic infection
- •7. Major surgery and/or hospitalization for any reason within 30 days
- •8. History of Neisseria meningitidis infection within 6 months prior
- •9. Known HIV infection with a documented CD4 count <200 cells/µL
- •10. Transfusion or receipt of blood products within 3 months or current participation in a chronic transfusion protocol
- •11. Immunized with a live attenuated vaccine within 30 days
- •12. History of hematopoietic stem cell transplant
- •13. Known or suspected hereditary complement deficiency
- •14. Pregnant or breastfeeding, or intending to become pregnant during the study or within 6 months after the study drug administration
- •15. Participation in another interventional treatment study with an investigational agent or use of any experimental therapy within the prior 28 days or within five half-lives of that investigational product, whichever was greater
研究者
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