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 July 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: July 18, 2014
Last verified: July 2014
  Purpose

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.


Condition Intervention Phase
Sickle Cell Disease
Drug: Prasugrel
Drug: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 3, Double-Blind, Randomized, Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients With Sickle Cell Disease.

Resource links provided by NLM:


Further study details as provided by Eli Lilly and Company:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 240
Study Start Date: April 2013
Estimated Study Completion Date: July 2016
Estimated Primary Completion Date: July 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Drug: Prasugrel
Administered orally
Other Names:
  • LY640315
  • Effient
  • Efient
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.
Drug: Placebo
Administered orally

  Eligibility

Ages Eligible for Study:   2 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01794000

Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559

  Show 63 Study Locations
Sponsors and Collaborators
Eli Lilly and Company
Daiichi Sankyo Inc.
Investigators
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
  More Information

No publications provided

Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01794000     History of Changes
Other Study ID Numbers: 13038, H7T-MC-TADO, 2012-003837-41
Study First Received: February 14, 2013
Last Updated: July 18, 2014
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Brazil: National Health Surveillance Agency
Canada: Health Canada
Egypt: Ministry of Health and Population
France: Agence Nationale de Sécurité du Médicament et des produits de santé
Ghana : Food and Drugs Board
Italy: Ethics Committee
Kenya: Pharmacy and Poisons Board
Lebanon: Ministry of Public Health
Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
Oman: Ministry of Health, Sultanate of Oman
Saudi Arabia: Ministry of Health
Turkey: Ministry of Health
United Arab Emirates: Drug Control Department - Medicines and Pharmacy Control - Ministry of Health
United Arab Emirates: General Authority for Health Services for Abu Dhabi
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Prasugrel
Purinergic P2Y Receptor Antagonists
Purinergic P2 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on July 20, 2014