Trial record 1 of 1 for:    H7T-MC-TADO
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A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Eli Lilly and Company
Sponsor:
Collaborator:
Daiichi Sankyo Inc.
Information provided by (Responsible Party):
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT01794000
First received: February 14, 2013
Last updated: September 19, 2014
Last verified: September 2014

February 14, 2013
September 19, 2014
April 2013
July 2015   (final data collection date for primary outcome measure)
Number of Vaso-Occlusive Crisis (VOC) Events per Participant per Year (Rate of VOC) [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01794000 on ClinicalTrials.gov Archive Site
  • Monthly Rate of Days with Pain [ Time Frame: Randomization through 9 Months ] [ Designated as safety issue: No ]
  • Monthly Mean in Faces Pain Scale-Revised Score [ Time Frame: Randomization through 9 Months ] [ Designated as safety issue: No ]
  • Number of Painful Crisis Events per Participant per Year (Rate of Painful Crisis) [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: No ]
  • Number of Hospitalizations for VOC per Participant per Year (Rate of Hospitalizations) [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: No ]
  • Number of Acute Chest Syndrome per Participant per Year (Rate of Acute Chest Syndrome) [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: No ]
  • Number of Red Blood Cell (RBC) Transfusions due to SCD per Participant per Year (Rate of RBC Infusions) [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: No ]
  • Monthly Rate of Days of Analgesic Use [ Time Frame: Randomization through 9 Months ] [ Designated as safety issue: No ]
  • Quarterly Rate of School Absence due to Sickle Cell Pain [ Time Frame: Randomization through 9 Months ] [ Designated as safety issue: No ]
  • Percentage of Participants with Transient Ischemic Attack (TIA)/Ischemic Stroke [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: No ]
  • Number of Days Hospitalized for VOC [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: No ]
  • Time from Randomization to First and Second VOC [ Time Frame: Randomization to First and Second VOC (Estimated up to 24 Months) ] [ Designated as safety issue: No ]
  • Percentage of Participants with Hemorrhagic Events Requiring Medical Intervention [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: Yes ]
  • Monthly Rate of Days with Pain [ Time Frame: Randomization through 9 Months ] [ Designated as safety issue: No ]
  • Monthly Mean in Faces Pain Scale-Revised Score [ Time Frame: Randomization through 9 Months ] [ Designated as safety issue: No ]
  • Number of Hospitalizations for VOC per Participant per Year (Rate of Hospitalizations) [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: No ]
  • Number of Acute Chest Syndrome per Participant per Year (Rate of Acute Chest Syndrome) [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: No ]
  • Number of Red Blood Cell (RBC) Transfusions due to SCD per Participant per Year (Rate of RBC Infusions) [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: No ]
  • Monthly Rate of Days of Analgesic Use [ Time Frame: Randomization through 9 Months ] [ Designated as safety issue: No ]
  • Quarterly Rate of School Absence due to Sickle Cell Pain [ Time Frame: Randomization through 9 Months ] [ Designated as safety issue: No ]
  • Percentage of Participants with Transient Ischemic Attack (TIA)/Ischemic Stroke [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: No ]
  • Number of Days Hospitalized for VOC [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: No ]
  • Time from Randomization to First and Second VOC [ Time Frame: Randomization to First and Second VOC (Estimated up to 24 Months) ] [ Designated as safety issue: No ]
  • Percentage of Participants with Hemorrhagic Events Requiring Medical Intervention [ Time Frame: Randomization through 24 Months ] [ Designated as safety issue: Yes ]
Not Provided
Not Provided
 
A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)
A Phase 3, Double-Blind, Randomized, Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients With Sickle Cell Disease.

The main purpose of the study is to evaluate the efficacy and safety of the study drug known as prasugrel for the reduction of Vaso-Occlusive Crisis events in pediatric participants with sickle cell disease. The study will also investigate reduction in daily pain in children who have sickle cell disease.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Sickle Cell Disease
  • Drug: Prasugrel
    Administered orally
    Other Names:
    • LY640315
    • Effient
    • Efient
  • Drug: Placebo
    Administered orally
  • Experimental: Prasugrel
    Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 136 to 231, as measured by VerifyNow instrument. This corresponds to a range of platelet inhibition of approximately 30% to 60%. The maximum possible dose allowed is 0.12 mg/kg, not to exceed 10 mg.
    Intervention: Drug: Prasugrel
  • Placebo Comparator: Placebo
    Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
240
July 2016
July 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Have SCD [homozygous sickle cell (HbSS) or hemoglobin (HbS) Beta^0 thalassemia]
  • Are participants with SCD who have had ≥2 episodes of vaso-occlusive crisis (VOC) in the past year
  • Have a body weight ≥19 kilograms (kg) and are ≥2 and <18 years of age, inclusive at the time of screening
  • If participants are ≥2 and ≤16 years of age, must have had a transcranial Doppler within the last year

Exclusion Criteria:

  • History of: transient ischemic attack (TIA)/ ischemic or hemorrhagic stroke, severe head trauma, intracranial hemorrhage, intracranial neoplasm, arteriovenous malformation, or aneurysm
  • History of abnormal or conditional [velocity in middle or anterior cerebral, or internal carotid artery ≥170 centimeter per second (cm/sec)] transcranial Doppler within the last year
  • History of, or are undergoing treatment with, chronic red blood cell (RBC) transfusion therapy
  • Are at an increased risk for bleeding complications
  • Are receiving chronic treatment with nonsteroidal anti-inflammatory drug (NSAID)s and cannot be switched to another analgesic
Both
2 Years to 17 Years
No
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559
United States,   Belgium,   Brazil,   Canada,   Egypt,   Ghana,   Italy,   Kenya,   Lebanon,   Oman,   Saudi Arabia,   Turkey,   United Arab Emirates,   United Kingdom
 
NCT01794000
13038, H7T-MC-TADO, 2012-003837-41
Yes
Eli Lilly and Company
Eli Lilly and Company
Daiichi Sankyo Inc.
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon-Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) Eli Lilly and Company
Eli Lilly and Company
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP