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

PHASE3CompletedINTERVENTIONAL
Enrollment

345

Participants

Timeline

Start Date

June 17, 2015

Primary Completion Date

May 3, 2019

Study Completion Date

June 27, 2019

Conditions
Anemia, Sickle Cell
Interventions
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

Placebo

Placebo (phosphate buffered saline) will be infused intravenously every 12 hours up to 15 doses maximum.

Trial Locations (142)

10029

Icahn School of Medicine at Mount Sinai, New York

10032

Columbia University Medical Center Research Pharmacy, New York

MS CHONY Pediatric Emergency Department, New York

MS CHONY Pediatric Hematology/Oncology Unit, New York

10305

Staten Island University Hospital, Staten Island

10461

Jacobi Medical Center, The Bronx

11203

Kings County Hospital Center - Pharmacy Department, Brooklyn

Kings County Hospital Center, Brooklyn

State University of New York (SUNY) - Downstate Medical Center, Brooklyn

SUNY Downstate Medical Center University Hospital of Brooklyn, Brooklyn

15213

UPMC Presbyterian, Pittsburgh

15224

Children's Hospital of Pittsburgh of UPMC, Pittsburgh

15232

UPMC Hillman Cancer Center, Pittsburgh

19141

Einstein Medical Center Philadelphia, Philadelphia

20001

Howard University Center for Sickle Cell Disease, Washington D.C.

20010

Medstar Health Research Institute, Washington D.C.

20060

Howard University Hospital, Washington D.C.

21201

University of Maryland Medical System Investigational Pharmacy, Baltimore

University of Maryland Medical System, Baltimore

21205

Johns Hopkins Medicine, Baltimore

The Johns Hopkins University School of Medicine, Baltimore

21287

Johns Hopkins Medicine, Baltimore

23298

Main Hospital - Virginia Commonwealth University, Richmond

Virginia Commonwealth University-Investigational Drug Services, Richmond

Virginia Commonwealth University, Richmond

27710

Duke University Hospital, Durham

Duke University Medical Center, Durham

27834

East Carolina University Brody School of Medicine, Greenville

Leo W. Jenkins Cancer Center, Greenville

Vidant Medical Center, Greenville

29425

Medical University of South Carolina - Hospital, Charleston

Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center, Charleston

Medical University of South Carolina, Charleston

MUSC Investigational Drug Services, Charleston

30303

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

Grady Health System, Atlanta

30322

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

Emory Children's Center, Atlanta

30342

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

Children's Healthcare of Atlanta: Scottish Rite Campus, Atlanta

30912

Augusta University Clinical Research Pharmacy, Augusta

Augusta University Medical Center, Augusta

Augusta University, Augusta

31404

Memorial Family Medicine Ctr. @Memorial Health Univ Med Ct, Savannah

Memorial Health University Medical Center, Savannah

32608

UF Health Davis Cancer Pavillion and Shands Med Plaza, Gainesville

UF Health Shands Cancer Hospital, Gainesville

32610

UF Health Shands Hospital, Gainesville

33136

Jackson Memorial Hospital, Miami

University Of Miami, Miami

33407

Children's Hematology and Oncology Associates, West Palm Beach

St. Mary's Medical Center, West Palm Beach

33606

Investigational Drug Service Tampa General Hospital, Tampa

Tampa General Hospital Center of Research Excellence, Tampa

Tampa General Hospital, Tampa

University of South Florida, Tampa

33607

St. Joseph's Children's Hospital, Tampa

33908

Golisano Children's Hospital of Southwest Florida, Fort Myers

36604

University of South Alabama Children's and Women's Hospital, Mobile

39216

University of Mississippi Medical Center-Outpatient Clinical Research Unit, Jackson

University Of Mississippi Medical Center, Jackson

40202

Kosair Charities Pediatric Clinical Research Unit, Louisville

Norton Children´s Hospital, Louisville

The Novak Center for Children's Health, Louisville

University of Louisville Health Sciences Center, Louisville

University of Louisville Physicians Pediatric Hematology Oncology, Louisville

43203

The Ohio State University Wexner Medical Center East, Columbus

43205

Nationwide Childrens Hospital, Columbus

43210

The Ohio State University Investigational Drug Services, Columbus

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

The Ohio State University Wexner Medical Center, Columbus

45219

University of Cincinnati Medical Center/ Investigational Pharmacy, Cincinnati

University of Cincinnati Medical Center/Research Office, Cincinnati

University of Cincinnati Medical Center, Cincinnati

University of Cincinnati Physicians Company LLC, Cincinnati

University of Cincinnati- Hoxworth Building, Cincinnati

45229

UC Health Ridgeway Hospital, Cincinnati

45402

Five Rivers Medical Surgical Health Center, Dayton

45409

Miami Valley Hospital, Dayton

48201

Children's Hospital of Michigan, Detroit

Detroit Medical Center Pharmacy, Detroit

Wayne State University / Detroit Receiving Hospital, Detroit

52242

University of Iowa Hospitals and Clinics, Iowa City

60612

University of Illinois at Chicago Clinical Research Center, Chicago

University of Illinois Hospital and Health Sciences System, Chicago

60637

The University of Chicago/Comer Children's Hospital, Chicago

University of Chicago, Investigational Drug Service Pharmacy, Chicago

63108

Center for Outpatient Health, St Louis

63110

Barnes-Jewish Hospital Department of Pharmacy, St Louis

Barnes-Jewish Hospital, St Louis

Center for Advanced Medicine, St Louis

Washington University School of Medicine, St Louis

64108

Children's Mercy Hospital, Kansas City

70808

Our Lady of the Lake Regional Medical Center, Baton Rouge

St. Jude Affiliate Clinic, Baton Rouge

70809

Our Lady of the Lake Physician Group-Medical Oncology, Baton Rouge

72202

Arkansas Children's Hospital Research Pharmacy, Little Rock

Arkansas Children's Hospital, Little Rock

76051

Cook Children's Hematology and Oncology Center-Grapevine, Grapevine

76104

Cook Children's Hematology and Oncology Center, Fort Worth

Cook Children's Medical Center, Fort Worth

77030

Texas Children's Hospital - Clinical Research Center, Houston

Texas Children´s Hospital, Houston

University of Texas Medical School, Houston

80045

University of Colorado CTRC, Aurora

University of Colorado Hospital, Aurora

84113

Primary Children's Hospital, Salt Lake City

94609

UCSF Benioff Children's Hospital Oakland, Oakland

95817

UC Davis Medical Center Main Hospital, Sacramento

UC Davis Medical Center, Sacramento

University of California Davis Medical Center, Sacramento

21287-6180

The Johns Hopkins Hospital, Baltimore

02115

Boston Children's Hospital, Boston

Brigham and Womens Hospital, Boston

Center for Clinical Investigation, Brigham & Women's Hospital, Boston

Investigational Drug Services, Boston

02118

Boston Medical Center E7E, Boston

Boston Medical Center, Boston

Boston University Medical Center, Boston

08901

Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital, New Brunswick

Rutgers-Robert Wood Johnson Medical School, New Brunswick

08903

Rutgers Cancer Institute Of New Jersey, New Brunswick

02903

Hasbro Children's Hospital, Providence

Rhode Island Hospital-Pharmacy Service, Providence

Rhode Island Hospital, Providence

02906

The Miriam Hospital, Providence

T5H 3V9

Royal Alexandra Hospital, Edmonton

T5R 4H5

Miseracordia Community Hospital, Edmonton

T6G 1Z1

Kaye Edmonton Clinic 3 C, Edmonton

University of Alberta Hospital, Pharmacy Services, Edmonton

T6G 2B7

Stollery Children's Hospital, Edmonton

University of Alberta Hospital, Edmonton

T6G 2V2

Research transition Facility, Edmonton

T6L 5X8

Grey Nuns Community Hospital, Edmonton

V6E 1M7

St. Paul's Hospital, Vancouver

V6Z 1Y6

St. Paul's Hospital, Vancouver

K1H 8L1

Children's Hospital Of Eastern Ontario, Ottawa

M5G 2C4

University Health Network, Toronto General Hospital, Toronto

M5G1X8

The Hospital for Sick Children, Toronto

H3T 1C5

Centre Hospitalier Universitaire Sainte-Justine, Montreal

H4A 3J1

McGill University Health Centre, Royal Victoria Hospital, Montreal

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

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

GlycoMimetics Incorporated

INDUSTRY

lead

Biossil Inc.

INDUSTRY