Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease

Last updated: February 8, 2021
Sponsor: GlycoMimetics Incorporated
Overall Status: Terminated

Phase

3

Condition

Sickle Cell Disease

Anemia

Bone Marrow Disorder

Treatment

N/A

Clinical Study ID

NCT02433158
B5201003
  • Ages > 6
  • All Genders

Study Summary

This is an open label extension study in subjects with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Completion of Study B5201002.
  • Documented diagnosis of SCD.
  • At least 6 years of age.
  • Male and female subjects of childbearing potential and at risk for pregnancy mustagree to use a highly effective method of contraception throughout the study.
  • Diagnosis of VOC necessitating IV opioids and admission to the hospital.
  • Able to receive the first dose of rivipansel within 24 hours from administration ofthe first dose of IV opioids for this hospitalization.

Exclusion

Exclusion Criteria:

  • Non-compliance with study procedures in the double blind study (B5201002).
  • Occurrence of any severe and/or generalized cutaneous manifestation or any otheradverse event during participation in Study B5201002 that was related to study drugand which would therefore make it inappropriate for the subject to receive rivipanselin the current study.
  • Other severe acute or chronic medical or psychiatric condition or laboratoryabnormality that may increase the risk associated with study participation or studydrug administration or may interfere with the interpretation of study results.
  • Clinically significant deterioration in renal function in Study B5201002.
  • Pregnant female subjects, breastfeeding female subjects and male and female subjectsof childbearing potential who are unwilling or unable to use a highly effective methodof contraception.
  • Active use of illicit drugs and/or alcohol dependence.

Study Design

Total Participants: 154
Study Start date:
December 16, 2015
Estimated Completion Date:
November 15, 2019

Study Description

This is an open label extension study in subjects who are 6 years of age or older with Sickle Cell Disease (SCD) who have completed the double blind Phase 3 study (B5201002). This study is designed to evaluate the safety and describe the efficacy of rivipansel as treatment for one or more vaso-occlusive crisis (VOC) events in hospitalized subjects with SCD.

Connect with a study center

  • Grey Nuns Community Hospital

    Edmonton, Alberta T6L 5X8
    Canada

    Site Not Available

  • Kaye Edmonton Clinic 3C

    Edmonton, Alberta T6G 1Z1
    Canada

    Site Not Available

  • Miseracordia Community Hospital

    Edmonton, Alberta T5R 4H5
    Canada

    Site Not Available

  • Research transition Facility

    Edmonton, Alberta T6G 2V2
    Canada

    Site Not Available

  • Royal Alexandra Hospital

    Edmonton, Alberta T5H 3V9
    Canada

    Site Not Available

  • Stollery Children's Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • University of Alberta Hospital

    Edmonton, Alberta T6G 2B7
    Canada

    Site Not Available

  • University of Alberta Hospital, Pharmacy Services

    Edmonton, Alberta T6G 1Z1
    Canada

    Site Not Available

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario K1H 8L1
    Canada

    Site Not Available

  • The Hospital for Sick Children

    Toronto, Ontario M5G 1X8
    Canada

    Site Not Available

  • Centre Hospitalier Universitaire Sainte-Justine

    Montreal, Quebec H3T 1C5
    Canada

    Site Not Available

  • The Montreal Children's Hospital / McGill University Health Centre

    Montreal, Quebec H4A3J1
    Canada

    Site Not Available

  • University of South Alabama Women's and Children's Hospital

    Mobile, Alabama 36604
    United States

    Site Not Available

  • Arkansas Children's Hospital

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • Arkansas Children's Hospital Research Pharmacy

    Little Rock, Arkansas 72202
    United States

    Site Not Available

  • UCSF Benioff Children's Hospital Oakland

    Oakland, California 94609
    United States

    Site Not Available

  • UC Davis Medical Center Main Hospital

    Sacramento, California 95817
    United States

    Site Not Available

  • University of California Davis Medical Center

    Sacramento, California 95817
    United States

    Site Not Available

  • Howard University Center for Sickle Cell disease

    Washington, District of Columbia 20001
    United States

    Site Not Available

  • Howard University Hospital

    Washington, District of Columbia 20060
    United States

    Site Not Available

  • MedStar Health Research Institute

    Washington, District of Columbia 20010
    United States

    Site Not Available

  • Howard University Hospital

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

    Site Not Available

  • Golisano Childrens Hospital of Southwest Florida

    Fort Myers, Florida 33908
    United States

    Site Not Available

  • Uf Health Shands Hospital

    Gainesville, Florida 32610
    United States

    Site Not Available

  • Jackson Memorial Hospital

    Miami, Florida 33136
    United States

    Site Not Available

  • University of Miami

    Miami, Florida 33136
    United States

    Site Not Available

  • St. Joseph's Children's Hospital

    Tampa, Florida 33607
    United States

    Site Not Available

  • St. Mary's Medical Center

    West Palm Beach, Florida 33407
    United States

    Site Not Available

  • Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center/

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center:

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Children's Healthcare of Atlanta: Scottish Rite Campus

    Atlanta, Georgia 30342
    United States

    Site Not Available

  • Emory Children's Center

    Atlanta, Georgia 30322
    United States

    Site Not Available

  • Grady Health System

    Atlanta, Georgia 30303
    United States

    Site Not Available

  • Memorial Family Medicine Center

    Savannah, Georgia 31404
    United States

    Site Not Available

  • Memorial Health University Medical Center

    Savannah, Georgia 31404
    United States

    Site Not Available

  • The University of Chicago/Comer Children's Hospital

    Chicago, Illinois 60637
    United States

    Site Not Available

  • University of Chicago, Investigational Drug Service Pharmacy

    Chicago, Illinois 60637
    United States

    Site Not Available

  • Kosair Charities Pediatric Research Unit

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • Johns Hopkins Department of Medicine Clinical Trials Unit

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • Johns Hopkins Medicine

    Baltimore, Maryland 21287
    United States

    Site Not Available

  • The Johns Hopkins Hospital Department of Pharmacy Services

    Baltimore, Maryland 21287-6180
    United States

    Site Not Available

  • The Johns Hopkins University School of Medicine

    Baltimore, Maryland 21205
    United States

    Site Not Available

  • University of Maryland Medical System

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • University of Maryland Medical System Investigational Pharmacy

    Baltimore, Maryland 21201
    United States

    Site Not Available

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Center for Clinical Investigation, Brigham and Women's Hospital

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Investigational Drug Services

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • Children's Hospital of Michigan

    Detroit, Michigan 48201
    United States

    Site Not Available

  • University of Mississippi Medical Center

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • University of Mississippi Medical Center - Outpatient Clinical Research Unit

    Jackson, Mississippi 39216
    United States

    Site Not Available

  • Barnes-Jewish Hospital

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Barnes-Jewish Hospital Department of Pharmacy

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Center for Advanced Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Center for Outpatient Health

    Saint Louis, Missouri 63108
    United States

    Site Not Available

  • Washington University School of Medicine

    Saint Louis, Missouri 63110
    United States

    Site Not Available

  • Barnes-Jewish Hospital

    St. Louis, Missouri 63110
    United States

    Site Not Available

  • eStudySite

    Las Vegas, Nevada 89109
    United States

    Site Not Available

  • Cooper University Hospital

    Camden, New Jersey 08103
    United States

    Site Not Available

  • Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey 08903
    United States

    Site Not Available

  • Rutgers-Robert Wood Johnson Medical School

    New Brunswick, New Jersey 08901
    United States

    Site Not Available

  • Jacobi Medical Center

    Bronx, New York 10461
    United States

    Site Not Available

  • Kings County Hospital Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • SUNY Downstate Medical Center University Hospital of Brooklyn

    Brooklyn, New York 11203
    United States

    Site Not Available

  • State University of New York (SUNY) Downstate Medical Center

    Brooklyn, New York 11203
    United States

    Site Not Available

  • Columbia University Medical Center Research Pharmacy

    New York, New York 10032
    United States

    Site Not Available

  • MS CHONY Pediatric Emergency Department

    New York, New York 10032
    United States

    Site Not Available

  • MS CHONY Pediatric Hematology/Oncology Unit

    New York, New York 10032
    United States

    Site Not Available

  • Jacobi Medical Center

    The Bronx, New York 10461
    United States

    Site Not Available

  • Duke University Hospital, Investigational Drug Service

    Durham, North Carolina 27710
    United States

    Site Not Available

  • Duke University Medical Center

    Durham, North Carolina 27710
    United States

    Site Not Available

  • East Carolina University Brody School of Medicine

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • East Carolina University, Brody School of Medicine

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Leo W. Jenkins Cancer Center

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Vidant Medical Center

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • University of Cincinnati - Hoxworth Building

    Cincinnai, Ohio 45219
    United States

    Site Not Available

  • UC Health Ridgeway Hospital

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • University of Cincinnati - Hoxworth Building

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati Medical Center

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati Medical Center / Investigational Pharmacy

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati Medical Center / Research Office

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • University of Cincinnati Physicians Company LLC

    Cincinnati, Ohio 45219
    United States

    Site Not Available

  • The Ohio State University Investigational Drug Services

    Columbus, Ohio 43203
    United States

    Site Not Available

  • The Ohio State University James Comprehensive Cancer Hospital & Solove Research Institute

    Columbus, Ohio 43210
    United States

    Site Not Available

  • The Ohio State University Wexner Center East

    Columbus, Ohio 43203
    United States

    Site Not Available

  • The Ohio State University Wexner Medical Center

    Columbus, Ohio 43210
    United States

    Site Not Available

  • Five Rivers Medical Surgical Health Center

    Dayton, Ohio 45402
    United States

    Site Not Available

  • Einstein Medical Center Philadelphia

    Philadelphia, Pennsylvania 19141
    United States

    Site Not Available

  • UPMC Hillman Cancer Center

    Pittsburgh, Pennsylvania 15232
    United States

    Site Not Available

  • UPMC Presbyterian

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Hasbro Children's Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Rhode Island Hospital

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • Rhode Island Hospital-Pharmacy Service

    Providence, Rhode Island 02903
    United States

    Site Not Available

  • The Miriam Hospital

    Providence, Rhode Island 02906
    United States

    Site Not Available

  • MUSC Investigational Drug Services

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Medical University of South Carolina-Hospital

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Children's Medical Center

    Dallas, Texas 75235
    United States

    Site Not Available

  • Cook Children's Hematology and Oncology Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Cook Children's Medical Center

    Fort Worth, Texas 76104
    United States

    Site Not Available

  • Cook Children's Hematology and Oncology Center-Grapevine

    Grapevine, Texas 76051
    United States

    Site Not Available

  • University of Texas Medical School

    Houston, Texas 77030
    United States

    Site Not Available

  • Primary Children's Hospital

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Primary Children's Hospital Laboratory

    Salt Lake City, Utah 84113
    United States

    Site Not Available

  • Main Hospital-VCU

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Virginia Commonwealth University - Investigational Drug Services

    Richmond, Virginia 23298
    United States

    Site Not Available

  • Virginia Commonwealth University- Clinical Research Services Unit

    Richmond, Virginia 23298
    United States

    Site Not Available

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