PACTR201402000508243尚未招募未知
A Phase 3 double blind, randomized efficacy and safety comparison of prasugrel and placebo in pediatric patients with sickle cell disease.
适应症
试验速览
- 阶段
- 未知
- 状态
- 尚未招募
- 入组人数
- 220
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
- 2 Year(s) 至 18 Year(s)（—）
- 性别
- All
入选标准
- •(1) Are patients with SCD (laboratory determined HbSS or HbS beta zero
- •thalassemia) who have had ¿2 episodes of VOC in the past year
- •[2] Have a body weight ¿19 kg and are ¿2 and <18 years of age, inclusive at the
- •time of screening for the double-blind treatment period
- •[3] If patients are ¿2 and ¿16 years of age, must have had a transcranial Doppler
- •within the last year
- •[4] Use of hydroxyurea is permitted under this protocol if the patient has been on
- •a stable dose for the 60 days prior to randomization without signs of
- •hematologic toxicity within 60 days of screening (see Section 9.8).
- •[5] Have a legal representative that is in competent mental condition to provide
- •written informed consent on behalf of the study participant before entering the
- •study. The child may be required to give documented assent, if required by
- •local regulations.
- •[6] If sexually active, patients agree to use a reliable method of birth control
- •during the study until 1 month following the last dose of study drug. Females
- •of child-bearing potential must test negative for pregnancy at the time of
- •enrollment based on a serum pregnancy test.
排除标准
- •(7)Vaso-occlusive crisis (requiring medical intervention) within 15 days prior to
- •[8] Have a concomitant medical illness (for example, terminal malignancy) that in
- •the opinion of the investigator is associated with reduced survival.
- •[9] Hepatic dysfunction characterized by alanine aminotransferase (ALT) ¿3 x
- •upper limit of normal (ULN)
- •[10] Renal dysfunction requiring chronic dialysis or creatinine ¿1.2 mg/dL
- •[11] Contraindication for antiplatelet therapy
- •[12] History of intolerance or allergy to approved thienopyridines
- •[13] Patients with a hematocrit <18%[14] History of abnormal or conditional transcranial Doppler (velocity in middle or
- •anterior cerebral, or internal carotid artery ¿170 cm/sec) within the last year,
- •regardless of age
- •Bleeding Risk Criteria
- •[15] History of bleeding diathesis
- •[16] History of papillary necrosis
- •[17] Active internal bleeding
- •[18] History of spontaneous gastrointestinal bleeding
- •[19] Gross hematuria or >300 RBC/high-powered field (HPF) on urinalysis at the
- •time of screening
- •[20] History of vitreous hemorrhage or proliferative retinopathy
- •[21] Any of the following:
- •¿ History of TIA/ ischemic or hemorrhagic stroke
- •¿ Intracranial neoplasm, arteriovenous malformation, or aneurysm
- •¿ History of severe head trauma
- •¿ History of intracranial hemorrhage
- •[22] Have clinical findings, in the judgment of the investigator, associated with an
- •increased risk of bleeding
- •[23] Platelet count <100,000 per ¿L of blood
- •[24] Have had recent surgery (within 30 days prior to screening) or are scheduled
- •to undergo surgery within the next 60 days
- •[25] History of dysfunctional uterine bleeding
研究者
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