TADO
- Conditions
- PaediatricsSickle Cell DiseaseCirculatory System
- Registration Number
- PACTR201402000508243
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 220
(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.
(7)Vaso-occlusive crisis (requiring medical intervention) within 15 days prior to
screening
[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
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To assess the efficacy of prasugrel compared to placebo in in pediatric patients with SCD
- Secondary Outcome Measures
Name Time Method ong-term safety safety of prasugrel in pediatric patients with SCD;Long term efficacy of prasugrel in pediatric patients with SCD