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 2, 2014
Last verified: September 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

  Hide Study Locations
Locations
United States, California
Children's Hospital of Oakland Recruiting
Oakland, California, United States, 94609
Contact    510-428-3193      
Principal Investigator: Carolyn Hoppe         
Stanford Univ Medical Center Recruiting
Palo Alto, California, United States, 94304
Contact    650-723-5535      
Principal Investigator: Michael Jeng         
United States, Connecticut
Connecticut Children's Medical Center Recruiting
Hartford, Connecticut, United States, 06106
Contact    860-545-9630      
Principal Investigator: Donna Boruchov         
United States, District of Columbia
Howard University Hospital Recruiting
Washington, District of Columbia, United States, 20060
Contact    202-865-6498      
Principal Investigator: Sohail Rana         
United States, Florida
Nemours Children's Hospital Recruiting
Jacksonville, Florida, United States, 32207
Contact    904-697-3793      
Principal Investigator: Manisha Bansal         
Nemours Children's Hospital Recruiting
Pensacola, Florida, United States, 32504
Contact    850-505-4790      
Principal Investigator: Roger Berkow         
United States, Georgia
Emory University Recruiting
Atlanta, Georgia, United States, 30322
Contact    404-778-2561      
Principal Investigator: Carlton Dampier         
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
Contact    912-350-8568      
Principal Investigator: John Whittle         
United States, Illinois
Ann & Robert H Lurie Children's Hospital of Chicago Recruiting
Chicago, Illinois, United States, 60611
Contact    312-227-4834      
Principal Investigator: Alexis Thompson         
United States, Kentucky
University of Louisville Recruiting
Louisville, Kentucky, United States, 40202
Contact    502-629-5820      
Principal Investigator: Ashok Raj         
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact    617-355-2569      
Principal Investigator: Matthew Heeney         
United States, Michigan
Childrens Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
Contact    313-745-5515      
Principal Investigator: Sharada Sarnaik         
United States, Missouri
University of Missouri Health System Recruiting
Columbia, Missouri, United States, 65201
Contact    573-882-3961      
Principal Investigator: Thomas Loew         
Children's Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Contact    816-855-1760      
Principal Investigator: Gerald Woods         
Cardinal Glennon Children's Hospital Recruiting
St Louis, Missouri, United States, 63104
Contact    314-577-5638      
Principal Investigator: William Ferguson         
United States, New Jersey
Tomorrows Children's Institute Recruiting
Hackensack, New Jersey, United States, 07601
Contact    201-996-5437      
Principal Investigator: Frances Flug         
United States, New York
Albert Einstein College of Medicine Recruiting
Bronx, New York, United States, 10467
Contact    718-741-2342      
Principal Investigator: Deepa Manwani         
State University of New York Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Contact    718-270-4714      
Principal Investigator: Scott Miller         
United States, North Carolina
University of NC at Chapel Hill School of Medicine Recruiting
Chapel Hill, North Carolina, United States, 27599
Contact    919-966-1178      
Principal Investigator: Rupa Redding-Lallinger         
United States, Ohio
Childrens Hospital Medical Center Recruiting
Cincinnati, Ohio, United States, 45229
Contact    513-636-4266      
Principal Investigator: Charles Quinn         
Rainbow Babies and Children's Hospital Recruiting
Cleveland, Ohio, United States, 44106
Contact    216-844-3345      
Principal Investigator: Connie Piccone         
ProMedica Health System Recruiting
Toledo, Ohio, United States, 43606
Contact    419-291-9500      
Principal Investigator: Crawford Strunk         
United States, Pennsylvania
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact    267-426-9338      
Principal Investigator: Kim Smith-Whitley         
St Christophers Hospital For Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
Contact    215-427-6523      
Principal Investigator: Jennifer Eng         
Childrens Hospital of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15224
Contact    412-692-5961      
Principal Investigator: Debra Cohen         
United States, South Carolina
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
Contact    843-792-8912      
Principal Investigator: Julie Kanter-Washko         
United States, Tennessee
St Jude Childrens Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact    901-595-2813      
Principal Investigator: Jeremie Estepp         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact    804-828-9605      
Principal Investigator: India Sisler         
United States, Washington
Mary Bridge Children's Hospital and Health Center Recruiting
Tacoma, Washington, United States, 98405
Contact    253-403-3481      
Principal Investigator: Robert Irwin         
Belgium
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Brussel, Belgium, 1200
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Leuven, Belgium, 3000
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Montegnee, Belgium, 04420
Contact: Eli Lilly         
Brazil
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Not yet recruiting
Porto Alegre, Brazil, 90035-6335
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Not yet recruiting
Rio De Janeiro, Brazil, 20211-030
Contact: Eli Lilly         
Canada, Ontario
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Hamilton, Ontario, Canada, L8S 4L8
Contact: Eli Lilly         
Canada, Quebec
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Montreal, Quebec, Canada, H3T 1C5
Contact: Eli Lilly         
Egypt
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Alexandria, Egypt, 21131
Contact: Eli Lilly         
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Cairo, Egypt, 11566
Contact: Eli Lilly         
For additional information regarding investigative sites for this trial, contact 1-877-CTLILLY (1-877-285-4559, 1-317-615-4559) Mon - Fri from 9 AM to 5 PM Eastern Time (UTC/GMT - 5 hours, EST), or speak with your personal physician. Recruiting
Fayoum, Egypt, 63514
Contact: Eli Lilly         
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Ismailia, Egypt
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Mansoura, Egypt, 35516
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Zagazig, Egypt, 44519
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Ghana
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Agogo, Ghana
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Korle Bu, Ghana
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Italy
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Genova, Italy, 16128
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Modena, Italy, 40124
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Monza, Italy, 20900
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Padova, Italy, 35138
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Verona, Italy, 37126
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Kenya
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Busia, Kenya, 40100
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Kisumu, Kenya
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Kombewa, Kenya
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Nairobi, Kenya
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Lebanon
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Beirut, Lebanon, 5244
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Oman
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Muscat, Oman, 123
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Saudi Arabia
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Jeddah, Saudi Arabia, 21859
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Riyadh, Saudi Arabia, 11426
Contact: Eli Lilly         
Turkey
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Balcali Adana, Turkey, 01330
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Mersin, Turkey, 33079
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United Arab Emirates
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Abu Dhabi, United Arab Emirates
Contact: Eli Lilly         
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Dubai, United Arab Emirates
Contact: Eli Lilly         
United Kingdom
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Tooting, London, United Kingdom, SW17 0QT
Contact: Eli Lilly         
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London, United Kingdom, SE1 7EH
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London, United Kingdom, SE5 9RS
Contact: Eli Lilly         
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Manchester, United Kingdom, M13 9WL
Contact: Eli Lilly         
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: September 2, 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 September 16, 2014