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Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease

Primary Purpose

Anemia, Sickle Cell

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Rivipansel
Placebo
Sponsored by
GlycoMimetics Incorporated
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia, Sickle Cell focused on measuring Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, pain crisis, vaso-occlusive crisis, rivipansel, GMI-1070, selectin inhibitor, SCD, VOC

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • At least 6 years of age.
  • Documented diagnosis of sickle cell disease.
  • Diagnosis of vaso-occlusive crisis necessitating admission to the hospital with treatment including IV opioids.
  • Able to receive the first dose of study drug within 24 hours from the administration of IV opioids.

Exclusion Criteria:

  • Serious systemic infection
  • Acute Chest Syndrome
  • Serious concomitant medical problems (for example, stroke)
  • SCD pain atypical of VOC
  • Severe renal or hepatic impairment
  • Chronic pain rather than a presentation of acute VOC

Sites / Locations

  • University of South Alabama Children's and Women's Hospital
  • Arkansas Children's Hospital Research Pharmacy
  • Arkansas Children's Hospital
  • UCSF Benioff Children's Hospital Oakland
  • UC Davis Medical Center Main Hospital
  • UC Davis Medical Center
  • University of California Davis Medical Center
  • University of Colorado CTRC
  • University of Colorado Hospital
  • Howard University Center for Sickle Cell Disease
  • Medstar Health Research Institute
  • Howard University Hospital
  • Golisano Children's Hospital of Southwest Florida
  • UF Health Davis Cancer Pavillion and Shands Med Plaza
  • UF Health Shands Cancer Hospital
  • UF Health Shands Hospital
  • Jackson Memorial Hospital
  • University Of Miami
  • Investigational Drug Service Tampa General Hospital
  • Tampa General Hospital Center of Research Excellence
  • Tampa General Hospital
  • University of South Florida
  • St. Joseph's Children's Hospital
  • Children's Hematology and Oncology Associates
  • St. Mary's Medical Center
  • Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center
  • Grady Health System
  • Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center
  • Emory Children's Center
  • Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center
  • Children's Healthcare of Atlanta: Scottish Rite Campus
  • Augusta University Clinical Research Pharmacy
  • Augusta University Medical Center
  • Augusta University
  • Memorial Family Medicine Ctr. @Memorial Health Univ Med Ct
  • Memorial Health University Medical Center
  • University of Illinois at Chicago Clinical Research Center
  • University of Illinois Hospital and Health Sciences System
  • The University of Chicago/Comer Children's Hospital
  • University of Chicago, Investigational Drug Service Pharmacy
  • University of Iowa Hospitals and Clinics
  • Kosair Charities Pediatric Clinical Research Unit
  • Norton Children´s Hospital
  • The Novak Center for Children's Health
  • University of Louisville Health Sciences Center
  • University of Louisville Physicians Pediatric Hematology Oncology
  • Our Lady of the Lake Regional Medical Center
  • St. Jude Affiliate Clinic
  • Our Lady of the Lake Physician Group-Medical Oncology
  • University of Maryland Medical System Investigational Pharmacy
  • University of Maryland Medical System
  • Johns Hopkins Medicine
  • The Johns Hopkins University School of Medicine
  • The Johns Hopkins Hospital
  • Johns Hopkins Medicine
  • Boston Children's Hospital
  • Brigham and Womens Hospital
  • Center for Clinical Investigation, Brigham & Women's Hospital
  • Investigational Drug Services
  • Boston Medical Center E7E
  • Boston Medical Center
  • Boston University Medical Center
  • Children's Hospital of Michigan
  • Detroit Medical Center Pharmacy
  • Wayne State University / Detroit Receiving Hospital
  • University of Mississippi Medical Center-Outpatient Clinical Research Unit
  • University Of Mississippi Medical Center
  • Children's Mercy Hospital
  • Center for Outpatient Health
  • Barnes-Jewish Hospital Department of Pharmacy
  • Barnes-Jewish Hospital
  • Center for Advanced Medicine
  • Washington University School of Medicine
  • Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital
  • Rutgers-Robert Wood Johnson Medical School
  • Rutgers Cancer Institute Of New Jersey
  • Jacobi Medical Center
  • Kings County Hospital Center - Pharmacy Department
  • Kings County Hospital Center
  • State University of New York (SUNY) - Downstate Medical Center
  • SUNY Downstate Medical Center University Hospital of Brooklyn
  • Icahn School of Medicine at Mount Sinai
  • Columbia University Medical Center Research Pharmacy
  • MS CHONY Pediatric Emergency Department
  • MS CHONY Pediatric Hematology/Oncology Unit
  • Staten Island University Hospital
  • Duke University Hospital
  • Duke University Medical Center
  • East Carolina University Brody School of Medicine
  • Leo W. Jenkins Cancer Center
  • Vidant Medical Center
  • University of Cincinnati Medical Center/ Investigational Pharmacy
  • University of Cincinnati Medical Center/Research Office
  • University of Cincinnati Medical Center
  • University of Cincinnati Physicians Company LLC
  • University of Cincinnati- Hoxworth Building
  • UC Health Ridgeway Hospital
  • The Ohio State University Wexner Medical Center East
  • Nationwide Childrens Hospital
  • The Ohio State University Investigational Drug Services
  • The Ohio State University James Comprehensive Cancer Hospital & Solove Research Institute
  • The Ohio State University Wexner Medical Center
  • Five Rivers Medical Surgical Health Center
  • Miami Valley Hospital
  • Einstein Medical Center Philadelphia
  • UPMC Presbyterian
  • Children's Hospital of Pittsburgh of UPMC
  • UPMC Hillman Cancer Center
  • Hasbro Children's Hospital
  • Rhode Island Hospital-Pharmacy Service
  • Rhode Island Hospital
  • The Miriam Hospital
  • Medical University of South Carolina - Hospital
  • Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center
  • Medical University of South Carolina
  • MUSC Investigational Drug Services
  • Cook Children's Hematology and Oncology Center
  • Cook Children's Medical Center
  • Cook Children's Hematology and Oncology Center-Grapevine
  • Texas Children's Hospital - Clinical Research Center
  • Texas Children´s Hospital
  • University of Texas Medical School
  • Primary Children's Hospital
  • Main Hospital - Virginia Commonwealth University
  • Virginia Commonwealth University-Investigational Drug Services
  • Virginia Commonwealth University
  • Royal Alexandra Hospital
  • Miseracordia Community Hospital
  • Kaye Edmonton Clinic 3 C
  • University of Alberta Hospital, Pharmacy Services
  • Stollery Children's Hospital
  • University of Alberta Hospital
  • Research transition Facility
  • Grey Nuns Community Hospital
  • St. Paul's Hospital
  • St. Paul's Hospital
  • Children's Hospital Of Eastern Ontario
  • University Health Network, Toronto General Hospital
  • The Hospital for Sick Children
  • Centre Hospitalier Universitaire Sainte-Justine
  • McGill University Health Centre, Royal Victoria Hospital
  • The Montreal Children's Hospital/ McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Rivipansel Treatment Arm

Placebo Treatment Arm

Arm Description

Outcomes

Primary Outcome Measures

Time to readiness-for-discharge.
Time to readiness-for-discharge, defined as the difference between the readiness-for-discharge date and time and the start date and time of the first infusion of study drug.

Secondary Outcome Measures

Time to discharge.
Time to discharge, is the difference between the time and date of hospital discharge order and the time and date of start of the first infusion of study drug.
Cumulative IV opioid consumption from the time of the loading dose of study drug to discharge.
Cumulative IV opioid consumption from the time of the loading dose of study drug to discharge.
Time to discontinuation of IV opioids.
Time to discontinuation of IV opioids.
Cumulative IV opioid consumption within the first 24 hours post-loading dose of study drug.
Cumulative IV opioid consumption within the first 24 hours post-loading dose of study drug.
Percent of subjects re-hospitalized for VOC within 3 days of discharge.
Percent of subjects re-hospitalized for VOC within 3 days of discharge.

Full Information

First Posted
June 12, 2014
Last Updated
June 16, 2020
Sponsor
GlycoMimetics Incorporated
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1. Study Identification

Unique Protocol Identification Number
NCT02187003
Brief Title
Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
Official Title
A Phase 3, Multicenter ,Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Completed
Study Start Date
June 17, 2015 (Actual)
Primary Completion Date
May 3, 2019 (Actual)
Study Completion Date
June 25, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlycoMimetics Incorporated

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a clinical study evaluating the efficacy and safety of rivipansel (GMI-1070) in treating subjects with sickle cell disease (SCD) who are 6 years of age or older experiencing a pain crisis necessitating hospitalization.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Sickle Cell
Keywords
Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, pain crisis, vaso-occlusive crisis, rivipansel, GMI-1070, selectin inhibitor, SCD, VOC

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
345 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Rivipansel Treatment Arm
Arm Type
Experimental
Arm Title
Placebo Treatment Arm
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Rivipansel
Other Intervention Name(s)
GMI-1070
Intervention Description
Rivipansel (GMI-1070) will be infused intravenously every 12 hours up to 15 doses maximum. Subjects aged 12 and over who weigh more than 40 kilograms will receive a dose of 1680 mg of rivipansel, followed by a dose of 840 mg of rivipansel every 12 hours. All subjects aged 6 to 11 years and any subject who weighs 40 kilograms or less, will receive weight-based dosing (mg/kg) of 40 mg/kg of rivipansel (maximum of 1680 mg) followed by a dose of 20 mg/kg of rivipansel (maximum of 840 mg) every 12 hours.
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
phosphate buffered saline
Intervention Description
Placebo (phosphate buffered saline) will be infused intravenously every 12 hours up to 15 doses maximum.
Primary Outcome Measure Information:
Title
Time to readiness-for-discharge.
Description
Time to readiness-for-discharge, defined as the difference between the readiness-for-discharge date and time and the start date and time of the first infusion of study drug.
Time Frame
Assessments will be every 4 hours (from 6am to 10pm, daily) for the duration of hospitalization, an expected average of 5 days
Secondary Outcome Measure Information:
Title
Time to discharge.
Description
Time to discharge, is the difference between the time and date of hospital discharge order and the time and date of start of the first infusion of study drug.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Cumulative IV opioid consumption from the time of the loading dose of study drug to discharge.
Description
Cumulative IV opioid consumption from the time of the loading dose of study drug to discharge.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Time to discontinuation of IV opioids.
Description
Time to discontinuation of IV opioids.
Time Frame
Participants will be followed for the duration of hospital stay, an expected average of 5 days
Title
Cumulative IV opioid consumption within the first 24 hours post-loading dose of study drug.
Description
Cumulative IV opioid consumption within the first 24 hours post-loading dose of study drug.
Time Frame
Day 1
Title
Percent of subjects re-hospitalized for VOC within 3 days of discharge.
Description
Percent of subjects re-hospitalized for VOC within 3 days of discharge.
Time Frame
Within 3 days of discharge

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: At least 6 years of age. Documented diagnosis of sickle cell disease. Diagnosis of vaso-occlusive crisis necessitating admission to the hospital with treatment including IV opioids. Able to receive the first dose of study drug within 24 hours from the administration of IV opioids. Exclusion Criteria: Serious systemic infection Acute Chest Syndrome Serious concomitant medical problems (for example, stroke) SCD pain atypical of VOC Severe renal or hepatic impairment Chronic pain rather than a presentation of acute VOC
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
University of South Alabama Children's and Women's Hospital
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36604
Country
United States
Facility Name
Arkansas Children's Hospital Research Pharmacy
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
Arkansas Children's Hospital
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72202
Country
United States
Facility Name
UCSF Benioff Children's Hospital Oakland
City
Oakland
State/Province
California
ZIP/Postal Code
94609
Country
United States
Facility Name
UC Davis Medical Center Main Hospital
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
UC Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of Colorado CTRC
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
University of Colorado Hospital
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Howard University Center for Sickle Cell Disease
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20001
Country
United States
Facility Name
Medstar Health Research Institute
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Facility Name
Howard University Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20060
Country
United States
Facility Name
Golisano Children's Hospital of Southwest Florida
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33908
Country
United States
Facility Name
UF Health Davis Cancer Pavillion and Shands Med Plaza
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
UF Health Shands Cancer Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32608
Country
United States
Facility Name
UF Health Shands Hospital
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Jackson Memorial Hospital
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
University Of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Investigational Drug Service Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Tampa General Hospital Center of Research Excellence
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
St. Joseph's Children's Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Children's Hematology and Oncology Associates
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
St. Mary's Medical Center
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
Facility Name
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Grady Health System
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30303
Country
United States
Facility Name
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Emory Children's Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Children's Healthcare of Atlanta: Scottish Rite Campus
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Augusta University Clinical Research Pharmacy
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Augusta University Medical Center
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Augusta University
City
Augusta
State/Province
Georgia
ZIP/Postal Code
30912
Country
United States
Facility Name
Memorial Family Medicine Ctr. @Memorial Health Univ Med Ct
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
Memorial Health University Medical Center
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31404
Country
United States
Facility Name
University of Illinois at Chicago Clinical Research Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Illinois Hospital and Health Sciences System
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
The University of Chicago/Comer Children's Hospital
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Chicago, Investigational Drug Service Pharmacy
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kosair Charities Pediatric Clinical Research Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Norton Children´s Hospital
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
The Novak Center for Children's Health
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Health Sciences Center
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville Physicians Pediatric Hematology Oncology
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Our Lady of the Lake Regional Medical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
St. Jude Affiliate Clinic
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Our Lady of the Lake Physician Group-Medical Oncology
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
University of Maryland Medical System Investigational Pharmacy
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
University of Maryland Medical System
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
The Johns Hopkins University School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
The Johns Hopkins Hospital
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287-6180
Country
United States
Facility Name
Johns Hopkins Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21287
Country
United States
Facility Name
Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Brigham and Womens Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Center for Clinical Investigation, Brigham & Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Investigational Drug Services
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Facility Name
Boston Medical Center E7E
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Boston Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Boston University Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Children's Hospital of Michigan
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Detroit Medical Center Pharmacy
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
Wayne State University / Detroit Receiving Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48201
Country
United States
Facility Name
University of Mississippi Medical Center-Outpatient Clinical Research Unit
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
University Of Mississippi Medical Center
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39216
Country
United States
Facility Name
Children's Mercy Hospital
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Facility Name
Center for Outpatient Health
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63108
Country
United States
Facility Name
Barnes-Jewish Hospital Department of Pharmacy
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Barnes-Jewish Hospital
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Center for Advanced Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Rutgers-Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08901
Country
United States
Facility Name
Rutgers Cancer Institute Of New Jersey
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903
Country
United States
Facility Name
Jacobi Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States
Facility Name
Kings County Hospital Center - Pharmacy Department
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Kings County Hospital Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
State University of New York (SUNY) - Downstate Medical Center
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
SUNY Downstate Medical Center University Hospital of Brooklyn
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11203
Country
United States
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University Medical Center Research Pharmacy
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
MS CHONY Pediatric Emergency Department
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
MS CHONY Pediatric Hematology/Oncology Unit
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Staten Island University Hospital
City
Staten Island
State/Province
New York
ZIP/Postal Code
10305
Country
United States
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
East Carolina University Brody School of Medicine
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Leo W. Jenkins Cancer Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
Vidant Medical Center
City
Greenville
State/Province
North Carolina
ZIP/Postal Code
27834
Country
United States
Facility Name
University of Cincinnati Medical Center/ Investigational Pharmacy
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati Medical Center/Research Office
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati Physicians Company LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
University of Cincinnati- Hoxworth Building
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
UC Health Ridgeway Hospital
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Facility Name
The Ohio State University Wexner Medical Center East
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Nationwide Childrens Hospital
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43205
Country
United States
Facility Name
The Ohio State University Investigational Drug Services
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University James Comprehensive Cancer Hospital & Solove Research Institute
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
The Ohio State University Wexner Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43210
Country
United States
Facility Name
Five Rivers Medical Surgical Health Center
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45402
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
Einstein Medical Center Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19141
Country
United States
Facility Name
UPMC Presbyterian
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Children's Hospital of Pittsburgh of UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224
Country
United States
Facility Name
UPMC Hillman Cancer Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15232
Country
United States
Facility Name
Hasbro Children's Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Rhode Island Hospital-Pharmacy Service
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Facility Name
The Miriam Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02906
Country
United States
Facility Name
Medical University of South Carolina - Hospital
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
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
MUSC Investigational Drug Services
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Cook Children's Hematology and Oncology Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Cook Children's Medical Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Cook Children's Hematology and Oncology Center-Grapevine
City
Grapevine
State/Province
Texas
ZIP/Postal Code
76051
Country
United States
Facility Name
Texas Children's Hospital - Clinical Research Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Texas Children´s Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas Medical School
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Primary Children's Hospital
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84113
Country
United States
Facility Name
Main Hospital - Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University-Investigational Drug Services
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Royal Alexandra Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5H 3V9
Country
Canada
Facility Name
Miseracordia Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T5R 4H5
Country
Canada
Facility Name
Kaye Edmonton Clinic 3 C
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
University of Alberta Hospital, Pharmacy Services
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Facility Name
Stollery Children's Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2B7
Country
Canada
Facility Name
Research transition Facility
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2V2
Country
Canada
Facility Name
Grey Nuns Community Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6L 5X8
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6E 1M7
Country
Canada
Facility Name
St. Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Children's Hospital Of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Facility Name
University Health Network, Toronto General Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G1X8
Country
Canada
Facility Name
Centre Hospitalier Universitaire Sainte-Justine
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3T 1C5
Country
Canada
Facility Name
McGill University Health Centre, Royal Victoria Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada
Facility Name
The Montreal Children's Hospital/ McGill University Health Centre
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35981565
Citation
Dampier CD, Telen MJ, Wun T, Brown RC, Desai P, El Rassi F, Fuh B, Kanter J, Pastore Y, Rothman J, Taylor JG, Readett D, Sivamurthy KM, Tammara B, Tseng LJ, Lozier JN, Thackray H, Magnani JL, Hassell KL; RESET Investigators. A randomized clinical trial of the efficacy and safety of rivipansel for sickle cell vaso-occlusive crisis. Blood. 2023 Jan 12;141(2):168-179. doi: 10.1182/blood.2022015797.
Results Reference
derived
PubMed Identifier
35120836
Citation
Rebelo AL, Chevalier MT, Russo L, Pandit A. Role and therapeutic implications of protein glycosylation in neuroinflammation. Trends Mol Med. 2022 Apr;28(4):270-289. doi: 10.1016/j.molmed.2022.01.004. Epub 2022 Feb 1.
Results Reference
derived

Learn more about this trial

Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease

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