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Trial record 2 of 4 for:    Rivipansel | Sickle Cell Disease

Safety Of Rivipansel (GMI-1070) In The Treatment Of One or More Vaso-occlusive Crises 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: NCT02433158
Recruitment Status : Terminated (The B5201003 OLE study was terminated based on the failure of the 'parent" B5201002 study to meet its efficacy endpoints. Termination was not due to safety.)
First Posted : May 4, 2015
Last Update Posted : June 18, 2020
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

Brief 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).

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Sickle Cell Disease Sickle Cell Disorders Pain Crisis Vaso-occlusive Crisis Drug: Rivipansel Phase 3

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 154 participants
Allocation: Non-Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: AN OPEN-LABEL EXTENSION STUDY TO EVALUATE THE SAFETY OF RIVIPANSEL (GMI-1070) IN THE TREATMENT OF ONE OR MORE VASO-OCCLUSIVE CRISES IN HOSPITALIZED SUBJECTS WITH SICKLE CELL DISEASE
Actual Study Start Date : December 16, 2015
Actual Primary Completion Date : November 15, 2019
Actual Study Completion Date : November 15, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Cohort 1
includes one adult stratum (>18 years old) and one pediatric stratum (12-17 years old)
Drug: Rivipansel
Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses. Subjects aged 12 and over who weigh >40 kg, will receive a loading dose of 1680 mg followed by a maintenance dose of 840 mg. Subjects 6 to 11 years of age or subject who weighs 40 kg, will receive a loading dose of 40 mg/kg (maximum of 1680 mg) followed by a maintenance dose of 20 mg/kg (maximum of 840 mg).
Other Name: GMI-1070

Experimental: Cohort 2
includes one pediatric stratum (6-11 years old).
Drug: Rivipansel
Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses. Subjects aged 12 and over who weigh >40 kg, will receive a loading dose of 1680 mg followed by a maintenance dose of 840 mg. Subjects 6 to 11 years of age or subject who weighs 40 kg, will receive a loading dose of 40 mg/kg (maximum of 1680 mg) followed by a maintenance dose of 20 mg/kg (maximum of 840 mg).
Other Name: GMI-1070




Primary Outcome Measures :
  1. Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study. [ Time Frame: 18 months ]
    Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study, number of TEAEs over the study and rate of TEAEs per subject per Vaso-Occlusive Crisis (VOC) will be summarized overall, by system organ class and by preferred term.

  2. Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study. [ Time Frame: 18 months ]
    Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study, number of events of adjudicated ACS and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.

  3. Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study [ Time Frame: 18 months ]
    Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study, number of events of adjudicated severe and/or generalized cutaneous manifestations and the rates of these events per subject per Vaso-Occlusive Crisis (VOC) will be summarized.

  4. Number (%) of subjects with serious adverse events (SAEs) over the study. [ Time Frame: 18 months ]
    Number (%) of subjects with serious adverse events (SAEs) over the study, number of SAEs over the study and rate of SAEs per subject per VOC will be summarized overall, by system organ class and by preferred term.


Secondary Outcome Measures :
  1. Subject re hospitalization [ Time Frame: 18 months ]
    Number (%) of subjects re hospitalized for VOC within 7, 14, and 30 days of most recent discharge will be provided overall. Number of re hospitalizations for VOC within 7, 14, and 30 days of most recent discharge and the rate of re hospitalization for VOC within 7, 14, and 30 days of most recent discharge per subject per VOC will be provided as well.



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

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 must agree 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 of the first dose of IV opioids for this hospitalization.

Exclusion Criteria: Non compliance with study procedures in the double blind study (B5201002). Occurrence of any severe and/or generalized cutaneous manifestation or any other adverse event during participation in Study B5201002 that was related to study drug and which would therefore make it inappropriate for the subject to receive rivipansel in the current study. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug 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 subjects of childbearing potential who are unwilling or unable to use a highly effective method of contraception. Active use of illicit drugs and/or alcohol dependence.


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): NCT02433158


Locations
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United States, Alabama
University of South Alabama Women's and Children'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
UC Davis Medical Center Main Hospital
Sacramento, California, United States, 95817
University of California Davis Medical Center
Sacramento, California, United States, 95817
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 Childrens Hospital of Southwest Florida
Fort Myers, Florida, United States, 33908
Jackson Memorial Hospital
Miami, Florida, United States, 33136
University of Miami
Miami, Florida, United States, 33136
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
Memorial Family Medicine Center
Savannah, Georgia, United States, 31404
Memorial Health University Medical Center
Savannah, Georgia, United States, 31404
United States, Illinois
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, 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 Department of Medicine Clinical Trials Unit
Baltimore, Maryland, United States, 21205
The Johns Hopkins University School of Medicine
Baltimore, Maryland, United States, 21205
The Johns Hopkins Hospital Department of Pharmacy Services
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 Women's Hospital
Boston, Massachusetts, United States, 02115
Center for Clinical Investigation, Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Investigational Drug Services
Boston, Massachusetts, United States, 02115
United States, Michigan
Children's Hospital of Michigan
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
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
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
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
United States, North Carolina
Duke University Hospital, Investigational Drug Service
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
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 - Hoxworth Building
Cincinnati, Ohio, United States, 45219
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
UC Health Ridgeway Hospital
Cincinnati, Ohio, United States, 45229
The Ohio State University Investigational Drug Services
Columbus, Ohio, United States, 43203
The Ohio State University Wexner Center East
Columbus, Ohio, United States, 43203
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
United States, Pennsylvania
UPMC Presbyterian
Pittsburgh, Pennsylvania, United States, 15213
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 Lifespan Comprehensive Sickle Cell Center
Charleston, South Carolina, United States, 29425
Medical University of South Carolina-Hospital
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
University of Texas Medical School
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Hospital Laboratory
Salt Lake City, Utah, United States, 84113
Primary Children's Hospital
Salt Lake City, Utah, United States, 84113
United States, Virginia
Main Hospital-VCU
Richmond, Virginia, United States, 23298
Virginia Commonwealth University - Investigational Drug Services
Richmond, Virginia, United States, 23298
Virginia Commonwealth University- Clinical Research Services Unit
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 3C
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, Ontario
Children's Hospital of Eastern Ontario
Ottawa, Ontario, Canada, K1H 8L1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Canada, Quebec
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, Canada, H3T 1C5
The Montreal Children's Hospital / McGill University Health Centre
Montreal, Quebec, Canada, H4A3J1
Sponsors and Collaborators
GlycoMimetics Incorporated
Investigators
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Study Director: Pfizer CT.gov Call Center Pfizer
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Responsible Party: GlycoMimetics Incorporated
ClinicalTrials.gov Identifier: NCT02433158    
Other Study ID Numbers: B5201003
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: June 18, 2020
Last Verified: June 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by GlycoMimetics Incorporated:
Rivipansel
GMI-1070
Selectin Inhibitor
SCD
VOC
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn