A Study of Prasugrel in Pediatric Participants With Sickle Cell Disease (SCD)

NCT01794000 | Terminated Phase 3 Results DMC

• 3 other identifiers: 13038H7T-MC-TADO2012-003837-41
• Study Type: interventional
• Target: 341
• Locations: 14 countries
• Sites: 50

Brief Summary

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.

Conditions

Sickle Cell Disease

Outcome Measures

Primary Outcomes (1)

• Number of Vaso-Occlusive Crisis (VOC) Events Per Participant Per Year (Rate of VOC)

  The VOC is a composite endpoint of painful crisis or acute chest syndrome. Events that occurred within 7 days from the prior event onset date were not counted as a new episode. Data collected through the primary completion date reported below.

  Randomization through 24 Months

Secondary Outcomes (12)

• Monthly Rate of Days With Pain

  Randomization through 9 Months

• Monthly Mean in Faces Pain Scale-Revised Score

  Randomization through 9 Months

• Number of Painful Crisis Events Per Participant Per Year (Rate of Painful Crisis)

  Randomization through 24 Months

• Number of Hospitalizations for VOC Per Participant Per Year (Rate of Hospitalizations)

  Randomization through 24 Months

• Number of Acute Chest Syndrome Per Participant Per Year (Rate of Acute Chest Syndrome)

  Randomization through 24 Months

Study Arms (2)

Prasugrel

EXPERIMENTAL

Participants will be titrated from initial daily dose of 0.08 milligram per kilogram (mg/kg) of orally administered prasugrel monotherapy at randomization to a dose that will achieve a P2Y12 reaction units (PRU) level of 231 to 136, 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 daily, not to exceed 10 mg daily.

Drug: Prasugrel

Placebo

PLACEBO COMPARATOR

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

Interventions

Prasugrel DRUG

Administered orally

Also known as: LY640315, Effient, Efient

Prasugrel

Placebo DRUG

Administered orally

Placebo

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Eli Lilly and Company: lead
• Daiichi Sankyo: collaborator

Study Sites (50)

Children's Hospital of Oakland

Oakland, California, 94609, United States

Location

Stanford Univ Medical Center

Palo Alto, California, 94304, United States

Location

Connecticut Children's Medical Center

Hartford, Connecticut, 06106, United States

Location

Howard University Hospital

Washington D.C., District of Columbia, 20060, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Memorial Health University Medical Center

Savannah, Georgia, 31404, United States

Location

Ann & Robert H Lurie Children's Hospital of Chicago

Chicago, Illinois, 60611, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Childrens Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Albert Einstein College of Medicine

The Bronx, New York, 10467, United States

Location

University of NC at Chapel Hill School of Medicine

Chapel Hill, North Carolina, 27599, United States

Location

Childrens Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

Rainbow Babies and Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19134, United States

Location

St Christophers Hospital For Children

Philadelphia, Pennsylvania, 19134, United States

Location

Childrens Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

St Jude Childrens Research Hospital

Memphis, Tennessee, 38105, United States

Location

Mary Bridge Children's Hospital and Health Center

Tacoma, Washington, 98405, United States

Location

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.

Brussels, 1200, Belgium

Location

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Montegnée, 4420, Belgium

Location

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Rio de Janeiro, 20211-030, Brazil

Location

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Montreal, Quebec, H3T 1C5, Canada

Location

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Al Fayyum, 63514, Egypt

Location

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Al Mansurah, 35516, Egypt

Location

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Alexandria, 21131, Egypt

Location

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Cairo, 11566, Egypt

Location

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Ismailia, Egypt

Location

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Zagazig, 44519, Egypt

Location

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Agogo, Ghana

Location

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Korle Bu, Ghana

Location

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Genova, 16128, Italy

Location

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Modena, 40124, Italy

Location

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Monza, 20900, Italy

Location

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Padua, 35138, Italy

Location

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Verona, 37126, Italy

Location

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Busia, 40100, Kenya

Location

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Kisumu, Kenya

Location

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Kombewa, Kenya

Location

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Nairobi, Kenya

Location

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Beirut, 5244, Lebanon

Location

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Muscat, 123, Oman

Location

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Jeddah, 21859, Saudi Arabia

Location

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Balcali Adana, 01330, Turkey (Türkiye)

Location

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Mersin, 33079, Turkey (Türkiye)

Location

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Abu Dhabi, United Arab Emirates

Location

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Tooting, London, SW17 0QT, United Kingdom

Location

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London, SE1 7EH, United Kingdom

Location

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Manchester, M13 9WL, United Kingdom

Location

Related Publications (1)

• Heeney MM, Hoppe CC, Abboud MR, Inusa B, Kanter J, Ogutu B, Brown PB, Heath LE, Jakubowski JA, Zhou C, Zamoryakhin D, Agbenyega T, Colombatti R, Hassab HM, Nduba VN, Oyieko JN, Robitaille N, Segbefia CI, Rees DC; DOVE Investigators. A Multinational Trial of Prasugrel for Sickle Cell Vaso-Occlusive Events. N Engl J Med. 2016 Feb 18;374(7):625-35. doi: 10.1056/NEJMoa1512021. Epub 2015 Dec 8.

  PMID: 26644172 DERIVED

Related Links

• A Multinational Trial of Prasugrel for Sickle Cell Vaso-Occlusive Events

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

Prasugrel Hydrochloride

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Piperazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

The study was stopped following Submission Database Lock, the topline information indicated that the primary and secondary efficacy endpoints were not met.

Results Point of Contact

• Title: Chief Medical Officer
• Organization: Eli Lilly and Company

800-545-5979

Study Officials

• 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

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 14, 2013
• First Posted: February 18, 2013
• Study Start: April 1, 2013
• Primary Completion: July 1, 2015
• Study Completion: December 1, 2015
• Last Updated: September 25, 2019
• Results First Posted: July 27, 2016

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
• Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

Locations

LE (1); IT (5); KE (4); BR (1); BE (2); EG (6); OM (1); TU (2); AE (1); SA (1); US (20); CA (1); GB (3); GH (2)