Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 3 of 4 for:    Rivipansel | Sickle Cell Disease

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02187003
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

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.

Condition or disease Intervention/treatment Phase
Anemia, Sickle Cell Drug: Rivipansel Other: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 345 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : June 17, 2015
Actual Primary Completion Date : May 3, 2019
Actual Study Completion Date : June 25, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Rivipansel Treatment Arm Drug: Rivipansel
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.
Other Name: GMI-1070

Placebo Comparator: Placebo Treatment Arm Other: Placebo
Placebo (phosphate buffered saline) will be infused intravenously every 12 hours up to 15 doses maximum.
Other Name: phosphate buffered saline




Primary Outcome Measures :
  1. Time to readiness-for-discharge. [ Time Frame: Assessments will be every 4 hours (from 6am to 10pm, daily) for the duration of hospitalization, an expected average of 5 days ]
    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 :
  1. Time to discharge. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    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.

  2. 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 ]
    Cumulative IV opioid consumption from the time of the loading dose of study drug to discharge.

  3. Time to discontinuation of IV opioids. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    Time to discontinuation of IV opioids.

  4. Cumulative IV opioid consumption within the first 24 hours post-loading dose of study drug. [ Time Frame: Day 1 ]
    Cumulative IV opioid consumption within the first 24 hours post-loading dose of study drug.

  5. Percent of subjects re-hospitalized for VOC within 3 days of discharge. [ Time Frame: Within 3 days of discharge ]
    Percent of subjects re-hospitalized for VOC within 3 days of discharge.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   6 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02187003


Locations
Hide Hide 142 study locations
Layout table for location information
United States, Alabama
University of South Alabama Children's and Women's Hospital
Mobile, Alabama, United States, 36604
United States, Arkansas
Arkansas Children's Hospital Research Pharmacy
Little Rock, Arkansas, United States, 72202
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, California
UCSF Benioff Children's Hospital Oakland
Oakland, California, United States, 94609
UC Davis Medical Center Main Hospital
Sacramento, California, United States, 95817
UC Davis Medical Center
Sacramento, California, United States, 95817
University of California Davis Medical Center
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado CTRC
Aurora, Colorado, United States, 80045
University of Colorado Hospital
Aurora, Colorado, United States, 80045
United States, District of Columbia
Howard University Center for Sickle Cell Disease
Washington, District of Columbia, United States, 20001
Medstar Health Research Institute
Washington, District of Columbia, United States, 20010
Howard University Hospital
Washington, District of Columbia, United States, 20060
United States, Florida
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
UF Health Davis Cancer Pavillion and Shands Med Plaza
Gainesville, Florida, United States, 32608
UF Health Shands Cancer Hospital
Gainesville, Florida, United States, 32608
UF Health Shands Hospital
Gainesville, Florida, United States, 32610
Jackson Memorial Hospital
Miami, Florida, United States, 33136
University Of Miami
Miami, Florida, United States, 33136
Investigational Drug Service Tampa General Hospital
Tampa, Florida, United States, 33606
Tampa General Hospital Center of Research Excellence
Tampa, Florida, United States, 33606
Tampa General Hospital
Tampa, Florida, United States, 33606
University of South Florida
Tampa, Florida, United States, 33606
St. Joseph's Children's Hospital
Tampa, Florida, United States, 33607
Children's Hematology and Oncology Associates
West Palm Beach, Florida, United States, 33407
St. Mary's Medical Center
West Palm Beach, Florida, United States, 33407
United States, Georgia
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center
Atlanta, Georgia, United States, 30303
Grady Health System
Atlanta, Georgia, United States, 30303
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center
Atlanta, Georgia, United States, 30322
Emory Children's Center
Atlanta, Georgia, United States, 30322
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center
Atlanta, Georgia, United States, 30342
Children's Healthcare of Atlanta: Scottish Rite Campus
Atlanta, Georgia, United States, 30342
Augusta University Clinical Research Pharmacy
Augusta, Georgia, United States, 30912
Augusta University Medical Center
Augusta, Georgia, United States, 30912
Augusta University
Augusta, Georgia, United States, 30912
Memorial Family Medicine Ctr. @Memorial Health Univ Med Ct
Savannah, Georgia, United States, 31404
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
United States, Illinois
University of Illinois at Chicago Clinical Research Center
Chicago, Illinois, United States, 60612
University of Illinois Hospital and Health Sciences System
Chicago, Illinois, United States, 60612
The University of Chicago/Comer Children's Hospital
Chicago, Illinois, United States, 60637
University of Chicago, Investigational Drug Service Pharmacy
Chicago, Illinois, United States, 60637
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit
Louisville, Kentucky, United States, 40202
Norton Children´s Hospital
Louisville, Kentucky, United States, 40202
The Novak Center for Children's Health
Louisville, Kentucky, United States, 40202
University of Louisville Health Sciences Center
Louisville, Kentucky, United States, 40202
University of Louisville Physicians Pediatric Hematology Oncology
Louisville, Kentucky, United States, 40202
United States, Louisiana
Our Lady of the Lake Regional Medical Center
Baton Rouge, Louisiana, United States, 70808
St. Jude Affiliate Clinic
Baton Rouge, Louisiana, United States, 70808
Our Lady of the Lake Physician Group-Medical Oncology
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
University of Maryland Medical System Investigational Pharmacy
Baltimore, Maryland, United States, 21201
University of Maryland Medical System
Baltimore, Maryland, United States, 21201
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21205
The Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
The Johns Hopkins Hospital
Baltimore, Maryland, United States, 21287-6180
Johns Hopkins Medicine
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
Brigham and Womens Hospital
Boston, Massachusetts, United States, 02115
Center for Clinical Investigation, Brigham & Women's Hospital
Boston, Massachusetts, United States, 02115
Investigational Drug Services
Boston, Massachusetts, United States, 02115
Boston Medical Center E7E
Boston, Massachusetts, United States, 02118
Boston Medical Center
Boston, Massachusetts, United States, 02118
Boston University Medical Center
Boston, Massachusetts, United States, 02118
United States, Michigan
Children's Hospital of Michigan
Detroit, Michigan, United States, 48201
Detroit Medical Center Pharmacy
Detroit, Michigan, United States, 48201
Wayne State University / Detroit Receiving Hospital
Detroit, Michigan, United States, 48201
United States, Mississippi
University of Mississippi Medical Center-Outpatient Clinical Research Unit
Jackson, Mississippi, United States, 39216
University Of Mississippi Medical Center
Jackson, Mississippi, United States, 39216
United States, Missouri
Children's Mercy Hospital
Kansas City, Missouri, United States, 64108
Center for Outpatient Health
Saint Louis, Missouri, United States, 63108
Barnes-Jewish Hospital Department of Pharmacy
Saint Louis, Missouri, United States, 63110
Barnes-Jewish Hospital
Saint Louis, Missouri, United States, 63110
Center for Advanced Medicine
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital
New Brunswick, New Jersey, United States, 08901
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States, 08901
Rutgers Cancer Institute Of New Jersey
New Brunswick, New Jersey, United States, 08903
United States, New York
Jacobi Medical Center
Bronx, New York, United States, 10461
Kings County Hospital Center - Pharmacy Department
Brooklyn, New York, United States, 11203
Kings County Hospital Center
Brooklyn, New York, United States, 11203
State University of New York (SUNY) - Downstate Medical Center
Brooklyn, New York, United States, 11203
SUNY Downstate Medical Center University Hospital of Brooklyn
Brooklyn, New York, United States, 11203
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029
Columbia University Medical Center Research Pharmacy
New York, New York, United States, 10032
MS CHONY Pediatric Emergency Department
New York, New York, United States, 10032
MS CHONY Pediatric Hematology/Oncology Unit
New York, New York, United States, 10032
Staten Island University Hospital
Staten Island, New York, United States, 10305
United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27710
Duke University Medical Center
Durham, North Carolina, United States, 27710
East Carolina University Brody School of Medicine
Greenville, North Carolina, United States, 27834
Leo W. Jenkins Cancer Center
Greenville, North Carolina, United States, 27834
Vidant Medical Center
Greenville, North Carolina, United States, 27834
United States, Ohio
University of Cincinnati Medical Center/ Investigational Pharmacy
Cincinnati, Ohio, United States, 45219
University of Cincinnati Medical Center/Research Office
Cincinnati, Ohio, United States, 45219
University of Cincinnati Medical Center
Cincinnati, Ohio, United States, 45219
University of Cincinnati Physicians Company LLC
Cincinnati, Ohio, United States, 45219
University of Cincinnati- Hoxworth Building
Cincinnati, Ohio, United States, 45219
UC Health Ridgeway Hospital
Cincinnati, Ohio, United States, 45229
The Ohio State University Wexner Medical Center East
Columbus, Ohio, United States, 43203
Nationwide Childrens Hospital
Columbus, Ohio, United States, 43205
The Ohio State University Investigational Drug Services
Columbus, Ohio, United States, 43210
The Ohio State University James Comprehensive Cancer Hospital & Solove Research Institute
Columbus, Ohio, United States, 43210
The Ohio State University Wexner Medical Center
Columbus, Ohio, United States, 43210
Five Rivers Medical Surgical Health Center
Dayton, Ohio, United States, 45402
Miami Valley Hospital
Dayton, Ohio, United States, 45409
United States, Pennsylvania
Einstein Medical Center Philadelphia
Philadelphia, Pennsylvania, United States, 19141
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
Children's Hospital of Pittsburgh of UPMC
Pittsburgh, Pennsylvania, United States, 15224
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States, 15232
United States, Rhode Island
Hasbro Children's Hospital
Providence, Rhode Island, United States, 02903
Rhode Island Hospital-Pharmacy Service
Providence, Rhode Island, United States, 02903
Rhode Island Hospital
Providence, Rhode Island, United States, 02903
The Miriam Hospital
Providence, Rhode Island, United States, 02906
United States, South Carolina
Medical University of South Carolina - Hospital
Charleston, South Carolina, United States, 29425
Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center
Charleston, South Carolina, United States, 29425
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
MUSC Investigational Drug Services
Charleston, South Carolina, United States, 29425
United States, Texas
Cook Children's Hematology and Oncology Center
Fort Worth, Texas, United States, 76104
Cook Children's Medical Center
Fort Worth, Texas, United States, 76104
Cook Children's Hematology and Oncology Center-Grapevine
Grapevine, Texas, United States, 76051
Texas Children's Hospital - Clinical Research Center
Houston, Texas, United States, 77030
Texas Children´s Hospital
Houston, Texas, United States, 77030
University of Texas Medical School
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
United States, Virginia
Main Hospital - Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Virginia Commonwealth University-Investigational Drug Services
Richmond, Virginia, United States, 23298
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Canada, Alberta
Royal Alexandra Hospital
Edmonton, Alberta, Canada, T5H 3V9
Miseracordia Community Hospital
Edmonton, Alberta, Canada, T5R 4H5
Kaye Edmonton Clinic 3 C
Edmonton, Alberta, Canada, T6G 1Z1
University of Alberta Hospital, Pharmacy Services
Edmonton, Alberta, Canada, T6G 1Z1
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
University of Alberta Hospital
Edmonton, Alberta, Canada, T6G 2B7
Research transition Facility
Edmonton, Alberta, Canada, T6G 2V2
Grey Nuns Community Hospital
Edmonton, Alberta, Canada, T6L 5X8
Canada, British Columbia
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6E 1M7
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
Canada, Ontario
Children's Hospital Of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
University Health Network, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G1X8
Canada, Quebec
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
McGill University Health Centre, Royal Victoria Hospital
Montreal, Quebec, Canada, H4A 3J1
The Montreal Children's Hospital/ McGill University Health Centre
Montreal, Quebec, Canada, H4A 3J1
Sponsors and Collaborators
GlycoMimetics Incorporated
Investigators
Layout table for investigator information
Study Director: Pfizer CT.gov Call Center Pfizer
Layout table for additonal information
Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT02187003    
Other Study ID Numbers: B5201002
RESET ( Other Identifier: Alias Study Number )
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: June 22, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlycoMimetics Incorporated:
Sickle Cell Anemia
Sickle Cell Disease
Sickle Cell Disorders
pain crisis
vaso-occlusive crisis
rivipansel
GMI-1070
selectin inhibitor
SCD
VOC
Additional relevant MeSH terms:
Layout table for MeSH terms
Anemia, Sickle Cell
Anemia
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Hemoglobinopathies
Genetic Diseases, Inborn