EUCTR2013-002986-21-ES进行中（未招募）1 期
Evaluation of Purified Poloxamer 188 in Vaso-Occlusive Crisis of Sickle Cell Disease (EPIC): A Phase 3, Randomized, Double-Blind, Placebo-Controlled Multicenter Clinical Trial of MST-188 (purified poloxamer 188) Injection in Subjects with Sickle Cell Disease Experiencing Vaso-Occlusive Crisis - Evaluation of Purified Poloxamer 188 in Subjects in Crisis (EPIC)
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 388
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Written documentation of informed consent and assent as applicable. Note: Minors must provide assent to participate in this study at an age-appropriate level determined and approved by the Institutional Review Board (IRB)/Independent Ethics Committee (IEC) for the study center.
- •2. Subject is ?4 and ?65 years of age.
- •3. Subject has confirmed diagnosis of HbSS, HbSC, HbS?+thal, or HbS?0thal.
- •4. Subject is experiencing acute pain typical of VOC and requires treatment with parenteral opioid analgesia.
- •5. Subject has been in moderate to severe pain as a result of the current VOC for no more than 24 hours at the time of presentation to the study center and for at least 4 hours prior to randomization.
- •6. Subject is hospitalized or in the process of admission for VOC at time of randomization.
- •7. If the subject is taking hydroxyurea, the dose is expected to remain stable through discharge.
- •8. If sexually active, the subject agrees to use reliable contraception while participating in this study and for at least 30 days after discontinuation of blinded study drug infusion.
- •9. If the subject is female and of child-bearing potential, must have negative pregnancy test (urine or serum).
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 232
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 155
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Subject has suspected ACS, including either:
- •a) baseline chest X-ray indicating a new pulmonary infiltrate or
- •b) subject has acute respiratory symptoms consistent with ACS or with acute asthma attack.
- •2. Subject has platelet count <80,000/mm3.
- •3. Subject has a known or suspected bleeding disorder.
- •4. Subject has inadequate liver function defined as ALT >3X the institution?s upper limit of normal.
- •5. Subject has the following serum creatinine value:
- •? Age ?4-7 years: >0.8 mg/dL (>70.7 ?mol/L)
- •? Age ?8-13 years: >0.9 mg/dL (>79.6 ?mol/L)
- •? Age ?14 years: >1.0 mg/dL (>88.4 ?mol/L)
- •6. Subject is pregnant or nursing.
- •7. Subject has had an episode of painful crisis requiring hospitalization within the preceding 14 days.
- •8. Subject has been transfused within the past 14 days.
- •9. Subject is already hospitalized for any condition other than the current VOC.
- •10. Subject uses opioid analgesia on a daily basis for any reason.
- •11. Subject is currently receiving another investigational drug or has received any investigational drug within 30 days prior to randomization.
- •12. Subject presents with complications related to SCD, such as: aplastic crisis, priapism, sepsis, stroke, hepatic or splenic sequestration, or any complication expected to require surgical intervention.
- •13. Subject has experienced >5 hospitalizations for VOC in the prior 6 months.
- •14. Investigator believes subject is suffering from chronic pain (e.g., necrotic tissue resulting from repeated prior VOCs) and not acute pain associated with an ongoing VOC.
- •15. Subject is otherwise not an appropriate study candidate, in the Investigator's judgment.
- •16. Subject has been previously enrolled in the present trial or any prior MST-188 clinical trial.
研究者
相似试验
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Evaluation of Purified Poloxamer 188 in Subjects with Sickle Cell Disease Experiencing a Vaso-occlusive CrisisSickle Cell Disease with Vaso-Occlusive CrisisMedDRA version: 18.0Level: LLTClassification code 10040644Term: Sickle cell diseaseSystem Organ Class: 100000004850EUCTR2013-002986-21-BEMast Therapeutics, Inc.388
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