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

Primary Purpose

Sickle Cell Disease

Status

Terminated

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Prasugrel

Placebo

About this trial

This is an interventional treatment trial for Sickle Cell Disease

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Children's Hospital of Oakland
Stanford Univ Medical Center
Connecticut Children's Medical Center
Howard University Hospital
Emory University
Memorial Health University Medical Center
Ann & Robert H Lurie Children's Hospital of Chicago
Boston Children's Hospital
Childrens Hospital of Michigan
Children's Mercy Hospital
Albert Einstein College of Medicine
University of NC at Chapel Hill School of Medicine
Childrens Hospital Medical Center
Rainbow Babies and Children's Hospital
Children's Hospital of Philadelphia
St Christophers Hospital For Children
Childrens Hospital of Pittsburgh
Medical University of South Carolina
St Jude Childrens Research Hospital
Mary Bridge Children's Hospital and Health Center
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Prasugrel

Placebo

Arm Description

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.

Participants in this treatment group will receive daily orally administered placebo and will follow visit schedule identical to that in the active treatment group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Monthly Rate of Days With Pain

Monthly rate of days with pain was measured through participant diaries using a modified version of the Faces Pain Scale-Revised (FPS-R). Each day participants selected the face on the scale that reflected their worst pain related to sickle cell disease (SCD) on that day. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. Any day the participant selected a face other than face 0 was considered a day with pain. Monthly rate of days with pain was calculated for each participant by summing the number of days reported with any pain divided by the number of non-missing diary entries completed in the month. A month was defined as 4 weeks (28 days).The monthly rate was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are present below.

Monthly Mean in Faces Pain Scale-Revised Score

Each day participants selected the face on the FPS-R scale that reflected their worst pain related to sickle cell disease (SCD) on that day. Monthly mean in FPS-R score was calculated for each participant by summing the FPS-R score divided by the number of non-missing diary entries completed in the month. This pain scale contains six faces corresponding to the pain intensity of 0, 2, 4, 6, 8 or 10, in which 0 denotes no pain and 10 denotes the worst pain possible. A month was defined as 4 weeks (28 days). The monthly mean in FPS-R score was set to missing if there were more than 14 missing entries for the FPS-R in a specific month. Data collected through the primary completion date are presented below.

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

A painful crisis is defined as an onset of moderate to severe pain that lasts at least 2 hours for which there is no explanation other than vaso-occlusion and which requires therapy with oral or parenteral opioids, ketorolac, or other analgesics prescribed by a health care provider (HCP) in a medical setting such as a hospital, clinic, emergency room visit, or telephone management. The painful crisis that occurred within 7 days from the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below.

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

Hospitalization that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.

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

Acute chest syndrome was defined as an acute illness characterized by fever and/or respiratory symptoms, accompanied by a new pulmonary infiltrate on a chest X-ray. Acute chest syndrome that occurred within 7 days of the prior event onset date was not counted as a new episode. Data collected through the primary completion date are presented below.

Number of Red Blood Cell (RBC) Transfusions Due to Sickle Cell Disease (SCD) Per Participant Per Year (Rate of RBC Transfusions)

RBC transfusions that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.

Monthly Rate of Days of Analgesic Use

Monthly rate of days of analgesic use was measured through participant diaries and was calculated for each participant by summing the number of days they reported analgesic use divided by the number of diary entries completed in the month. A month was defined as 4 weeks (28 days). The monthly rate was set to missing if there were more than 14 missing entries for analgesic use in a specific month. Data collected through the primary completion date are presented below.

Quarterly Rate of School Absence Due to Sickle Cell Pain

Quarterly rate of school absence due to sickle cell pain was measured through participant diaries and was calculated for each participant by summing the number of days with school absence due to sickle cell pain divided by the number of school dates in the quarter. A quarter was defined as 12 weeks. The quarterly rate was set to missing if there were more than 6 weeks of missing diary entries during a specific quarter. Data collected through the primary completion date are presented below.

Time to First Transient Ischemic Attack (TIA)/Ischemic Stroke

Number of Days Hospitalized for VOC

The total length of hospitalization in days for VOC was calculated for each participant. Data collected through the primary completion date are presented below.

Time From Randomization to First and Second VOC

Data collected through the primary completion date are presented below.

Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention

Medical intervention was defined as any medical evaluation resulting in therapy or further investigation, as determined by a trained medical professional. Data collected from the first dose of study medication through 10 days after last dose of study medication during the double blind study period are presented below.

Full Information

NCT ID

NCT01794000

First Posted

February 14, 2013

Last Updated

September 10, 2019

Sponsor

Eli Lilly and Company

Collaborators

Daiichi Sankyo, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT01794000

Brief Title

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

Official Title

A Phase 3, Double-Blind, Randomized, Efficacy and Safety Comparison of Prasugrel and Placebo in Pediatric Patients With Sickle Cell Disease.

Study Type

Interventional

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Terminated

Why Stopped

The study is being terminated for lack of efficacy.

Study Start Date

April 2013 (undefined)

Primary Completion Date

July 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Eli Lilly and Company

Collaborators

Daiichi Sankyo, Inc.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

Detailed Description

The submission database was validated for data reported through the data cutoff date for the submission database lock (SDBL). The SDBL data cutoff was 17 July 2015 for all participants except for 2 in the youngest age group, for whom the SDBL data cutoff occurred on 08 August 2015. The data cutoff date for SDBL corresponds to the primary completion date for the study. The SDBL occurred on 31 August 2015. The study was stopped following SDBL and review of the topline information indicated that the primary and secondary efficacy endpoints were not met. Subsequently, the Sponsor requested that participants discontinue study drug immediately and that discontinuation visits for all active study participants be conducted as soon as feasible. After the data cutoff date for SDBL, the Sponsor continued to collect safety data through the final participants contact; some additional efficacy data were collected through the final visit. The last patient visit (LPV) occurred on 17 December 2015, which corresponds to the study completion date and led to the planned supplemental database lock (PSDBL) on 22 January 2016. This supplemental data base was originally designed to capture additional blinded and randomized information to enhance safety data for labeling should the study have been positive. The safety information contained in this record reflects the entire safety information and reflects the information from the supplemental data base lock in January of 2016. The efficacy information contained in this record reflects the information collected through primary completion date in the submission database. Primary analyses of the major efficacy objectives were repeated using the entire double-blind period data from the PSDBL and did not change the original conclusions and were consistent with the results from the original efficacy analyses included in the SDBL.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Sickle Cell Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

341 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Prasugrel

Arm Type

Experimental

Arm Description

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

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 Type

Drug

Intervention Name(s)

Prasugrel

Other Intervention Name(s)

LY640315, Effient, Efient

Intervention Description

Administered orally

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Administered orally

Primary Outcome Measure Information:

Title

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

Description

Time Frame

Randomization through 24 Months

Secondary Outcome Measure Information:

Title

Monthly Rate of Days With Pain

Description

Time Frame

Randomization through 9 Months

Title

Monthly Mean in Faces Pain Scale-Revised Score

Description

Time Frame

Randomization through 9 Months

Title

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

Description

Time Frame

Randomization through 24 Months

Title

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

Description

Hospitalization that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.

Time Frame

Randomization through 24 Months

Title

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

Description

Time Frame

Randomization through 24 Months

Title

Number of Red Blood Cell (RBC) Transfusions Due to Sickle Cell Disease (SCD) Per Participant Per Year (Rate of RBC Transfusions)

Description

RBC transfusions that occurred within 7 days of the prior event onset date were not counted as a new episode. Data collected through the primary completion date are presented below.

Time Frame

Randomization through 24 Months

Title

Monthly Rate of Days of Analgesic Use

Description

Time Frame

Randomization through 9 Months

Title

Quarterly Rate of School Absence Due to Sickle Cell Pain

Description

Time Frame

Randomization through 9 Months

Title

Time to First Transient Ischemic Attack (TIA)/Ischemic Stroke

Time Frame

Randomization through 24 Months

Title

Number of Days Hospitalized for VOC

Description

The total length of hospitalization in days for VOC was calculated for each participant. Data collected through the primary completion date are presented below.

Time Frame

Randomization through 24 Months

Title

Time From Randomization to First and Second VOC

Description

Data collected through the primary completion date are presented below.

Time Frame

Randomization to First VOC and Second VOC respectively (up to 24 Months)

Title

Percentage of Participants With Hemorrhagic Events Requiring Medical Intervention

Description

Time Frame

First Dose through 24 Months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

2 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

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)

Organizational Affiliation

Eli Lilly and Company

Official's Role

Study Director

Facility Information:

Facility Name

Children's Hospital of Oakland

City

Oakland

State/Province

California

ZIP/Postal Code

94609

Country

United States

Facility Name

Stanford Univ Medical Center

City

Palo Alto

State/Province

California

ZIP/Postal Code

94304

Country

United States

Facility Name

Connecticut Children's Medical Center

City

Hartford

State/Province

Connecticut

ZIP/Postal Code

06106

Country

United States

Facility Name

Howard University Hospital

City

Washington

State/Province

District of Columbia

ZIP/Postal Code

20060

Country

United States

Facility Name

Emory University

City

Atlanta

State/Province

Georgia

ZIP/Postal Code

30322

Country

United States

Facility Name

Memorial Health University Medical Center

City

Savannah

State/Province

Georgia

ZIP/Postal Code

31404

Country

United States

Facility Name

Ann & Robert H Lurie Children's Hospital of Chicago

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

Facility Name

Boston Children's Hospital

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02115

Country

United States

Facility Name

Childrens Hospital of Michigan

City

Detroit

State/Province

Michigan

ZIP/Postal Code

48201

Country

United States

Facility Name

Children's Mercy Hospital

City

Kansas City

State/Province

Missouri

ZIP/Postal Code

64108

Country

United States

Facility Name

Albert Einstein College of Medicine

City

Bronx

State/Province

New York

ZIP/Postal Code

10467

Country

United States

Facility Name

University of NC at Chapel Hill School of Medicine

City

Chapel Hill

State/Province

North Carolina

ZIP/Postal Code

27599

Country

United States

Facility Name

Childrens Hospital Medical Center

City

Cincinnati

State/Province

Ohio

ZIP/Postal Code

45229

Country

United States

Facility Name

Rainbow Babies and Children's Hospital

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44106

Country

United States

Facility Name

Children's Hospital of Philadelphia

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19134

Country

United States

Facility Name

St Christophers Hospital For Children

City

Philadelphia

State/Province

Pennsylvania

ZIP/Postal Code

19134

Country

United States

Facility Name

Childrens Hospital of Pittsburgh

City

Pittsburgh

State/Province

Pennsylvania

ZIP/Postal Code

15224

Country

United States

Facility Name

Medical University of South Carolina

City

Charleston

State/Province

South Carolina

ZIP/Postal Code

29425

Country

United States

Facility Name

St Jude Childrens Research Hospital

City

Memphis

State/Province

Tennessee

ZIP/Postal Code

38105

Country

United States

Facility Name

Mary Bridge Children's Hospital and Health Center

City

Tacoma

State/Province

Washington

ZIP/Postal Code

98405

Country

United States

Facility Name

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.

City

Brussel

ZIP/Postal Code

1200

Country

Belgium

Facility Name

City

Montegnee

ZIP/Postal Code

4420

Country

Belgium

Facility Name

City

Rio De Janeiro

ZIP/Postal Code

20211-030

Country

Brazil

Facility Name

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3T 1C5

Country

Canada

Facility Name

City

Alexandria

ZIP/Postal Code

21131

Country

Egypt

Facility Name

City

Cairo

ZIP/Postal Code

11566

Country

Egypt

Facility Name

City

Fayoum

ZIP/Postal Code

63514

Country

Egypt

Facility Name

City

Ismailia

Country

Egypt

Facility Name

City

Mansoura

ZIP/Postal Code

35516

Country

Egypt

Facility Name

City

Zagazig

ZIP/Postal Code

44519

Country

Egypt

Facility Name

City

Agogo

Country

Ghana

Facility Name

City

Korle Bu

Country

Ghana

Facility Name

City

Genova

ZIP/Postal Code

16128

Country

Italy

Facility Name

City

Modena

ZIP/Postal Code

40124

Country

Italy

Facility Name

City

Monza

ZIP/Postal Code

20900

Country

Italy

Facility Name

City

Padova

ZIP/Postal Code

35138

Country

Italy

Facility Name

City

Verona

ZIP/Postal Code

37126

Country

Italy

Facility Name

City

Busia

ZIP/Postal Code

40100

Country

Kenya

Facility Name

City

Kisumu

Country

Kenya

Facility Name

City

Kombewa

Country

Kenya

Facility Name

City

Nairobi

Country

Kenya

Facility Name

City

Beirut

ZIP/Postal Code

5244

Country

Lebanon

Facility Name

City

Muscat

ZIP/Postal Code

123

Country

Oman

Facility Name

City

Jeddah

ZIP/Postal Code

21859

Country

Saudi Arabia

Facility Name

City

Balcali Adana

ZIP/Postal Code

01330

Country

Turkey

Facility Name

City

Mersin

ZIP/Postal Code

33079

Country

Turkey

Facility Name

City

Abu Dhabi

Country

United Arab Emirates

Facility Name

City

Tooting

State/Province

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

City

Manchester

ZIP/Postal Code

M13 9WL

Country

United Kingdom

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing 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.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing URL

https://vivli.org/

Citations:

PubMed Identifier

26644172

Citation

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.

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

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