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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

Sponsor
GlycoMimetics Incorporated (Industry)
Overall Status
Completed
CT.gov ID
NCT02187003
Collaborator
(none)
345
Enrollment
142
Locations
2
Arms
48.3
Actual Duration (Months)
2.4
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
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 :
Jun 17, 2015
Actual Primary Completion Date :
May 3, 2019
Actual Study Completion Date :
Jun 25, 2019

Arms and Interventions

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 Names:
  • 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 Names:
  • phosphate buffered saline

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Time to readiness-for-discharge. [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. [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. [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. [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. [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. [Within 3 days of discharge]

      Percent of subjects re-hospitalized for VOC within 3 days of discharge.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of South Alabama Children's and Women's Hospital Mobile Alabama United States 36604
    2 Arkansas Children's Hospital Research Pharmacy Little Rock Arkansas United States 72202
    3 Arkansas Children's Hospital Little Rock Arkansas United States 72202
    4 UCSF Benioff Children's Hospital Oakland Oakland California United States 94609
    5 UC Davis Medical Center Main Hospital Sacramento California United States 95817
    6 UC Davis Medical Center Sacramento California United States 95817
    7 University of California Davis Medical Center Sacramento California United States 95817
    8 University of Colorado CTRC Aurora Colorado United States 80045
    9 University of Colorado Hospital Aurora Colorado United States 80045
    10 Howard University Center for Sickle Cell Disease Washington District of Columbia United States 20001
    11 Medstar Health Research Institute Washington District of Columbia United States 20010
    12 Howard University Hospital Washington District of Columbia United States 20060
    13 Golisano Children's Hospital of Southwest Florida Fort Myers Florida United States 33908
    14 UF Health Davis Cancer Pavillion and Shands Med Plaza Gainesville Florida United States 32608
    15 UF Health Shands Cancer Hospital Gainesville Florida United States 32608
    16 UF Health Shands Hospital Gainesville Florida United States 32610
    17 Jackson Memorial Hospital Miami Florida United States 33136
    18 University Of Miami Miami Florida United States 33136
    19 Investigational Drug Service Tampa General Hospital Tampa Florida United States 33606
    20 Tampa General Hospital Center of Research Excellence Tampa Florida United States 33606
    21 Tampa General Hospital Tampa Florida United States 33606
    22 University of South Florida Tampa Florida United States 33606
    23 St. Joseph's Children's Hospital Tampa Florida United States 33607
    24 Children's Hematology and Oncology Associates West Palm Beach Florida United States 33407
    25 St. Mary's Medical Center West Palm Beach Florida United States 33407
    26 Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center Atlanta Georgia United States 30303
    27 Grady Health System Atlanta Georgia United States 30303
    28 Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center Atlanta Georgia United States 30322
    29 Emory Children's Center Atlanta Georgia United States 30322
    30 Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center Atlanta Georgia United States 30342
    31 Children's Healthcare of Atlanta: Scottish Rite Campus Atlanta Georgia United States 30342
    32 Augusta University Clinical Research Pharmacy Augusta Georgia United States 30912
    33 Augusta University Medical Center Augusta Georgia United States 30912
    34 Augusta University Augusta Georgia United States 30912
    35 Memorial Family Medicine Ctr. @Memorial Health Univ Med Ct Savannah Georgia United States 31404
    36 Memorial Health University Medical Center Savannah Georgia United States 31404
    37 University of Illinois at Chicago Clinical Research Center Chicago Illinois United States 60612
    38 University of Illinois Hospital and Health Sciences System Chicago Illinois United States 60612
    39 The University of Chicago/Comer Children's Hospital Chicago Illinois United States 60637
    40 University of Chicago, Investigational Drug Service Pharmacy Chicago Illinois United States 60637
    41 University of Iowa Hospitals and Clinics Iowa City Iowa United States 52242
    42 Kosair Charities Pediatric Clinical Research Unit Louisville Kentucky United States 40202
    43 Norton Children´s Hospital Louisville Kentucky United States 40202
    44 The Novak Center for Children's Health Louisville Kentucky United States 40202
    45 University of Louisville Health Sciences Center Louisville Kentucky United States 40202
    46 University of Louisville Physicians Pediatric Hematology Oncology Louisville Kentucky United States 40202
    47 Our Lady of the Lake Regional Medical Center Baton Rouge Louisiana United States 70808
    48 St. Jude Affiliate Clinic Baton Rouge Louisiana United States 70808
    49 Our Lady of the Lake Physician Group-Medical Oncology Baton Rouge Louisiana United States 70809
    50 University of Maryland Medical System Investigational Pharmacy Baltimore Maryland United States 21201
    51 University of Maryland Medical System Baltimore Maryland United States 21201
    52 Johns Hopkins Medicine Baltimore Maryland United States 21205
    53 The Johns Hopkins University School of Medicine Baltimore Maryland United States 21205
    54 The Johns Hopkins Hospital Baltimore Maryland United States 21287-6180
    55 Johns Hopkins Medicine Baltimore Maryland United States 21287
    56 Boston Children's Hospital Boston Massachusetts United States 02115
    57 Brigham and Womens Hospital Boston Massachusetts United States 02115
    58 Center for Clinical Investigation, Brigham & Women's Hospital Boston Massachusetts United States 02115
    59 Investigational Drug Services Boston Massachusetts United States 02115
    60 Boston Medical Center E7E Boston Massachusetts United States 02118
    61 Boston Medical Center Boston Massachusetts United States 02118
    62 Boston University Medical Center Boston Massachusetts United States 02118
    63 Children's Hospital of Michigan Detroit Michigan United States 48201
    64 Detroit Medical Center Pharmacy Detroit Michigan United States 48201
    65 Wayne State University / Detroit Receiving Hospital Detroit Michigan United States 48201
    66 University of Mississippi Medical Center-Outpatient Clinical Research Unit Jackson Mississippi United States 39216
    67 University Of Mississippi Medical Center Jackson Mississippi United States 39216
    68 Children's Mercy Hospital Kansas City Missouri United States 64108
    69 Center for Outpatient Health Saint Louis Missouri United States 63108
    70 Barnes-Jewish Hospital Department of Pharmacy Saint Louis Missouri United States 63110
    71 Barnes-Jewish Hospital Saint Louis Missouri United States 63110
    72 Center for Advanced Medicine Saint Louis Missouri United States 63110
    73 Washington University School of Medicine Saint Louis Missouri United States 63110
    74 Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital New Brunswick New Jersey United States 08901
    75 Rutgers-Robert Wood Johnson Medical School New Brunswick New Jersey United States 08901
    76 Rutgers Cancer Institute Of New Jersey New Brunswick New Jersey United States 08903
    77 Jacobi Medical Center Bronx New York United States 10461
    78 Kings County Hospital Center - Pharmacy Department Brooklyn New York United States 11203
    79 Kings County Hospital Center Brooklyn New York United States 11203
    80 State University of New York (SUNY) - Downstate Medical Center Brooklyn New York United States 11203
    81 SUNY Downstate Medical Center University Hospital of Brooklyn Brooklyn New York United States 11203
    82 Icahn School of Medicine at Mount Sinai New York New York United States 10029
    83 Columbia University Medical Center Research Pharmacy New York New York United States 10032
    84 MS CHONY Pediatric Emergency Department New York New York United States 10032
    85 MS CHONY Pediatric Hematology/Oncology Unit New York New York United States 10032
    86 Staten Island University Hospital Staten Island New York United States 10305
    87 Duke University Hospital Durham North Carolina United States 27710
    88 Duke University Medical Center Durham North Carolina United States 27710
    89 East Carolina University Brody School of Medicine Greenville North Carolina United States 27834
    90 Leo W. Jenkins Cancer Center Greenville North Carolina United States 27834
    91 Vidant Medical Center Greenville North Carolina United States 27834
    92 University of Cincinnati Medical Center/ Investigational Pharmacy Cincinnati Ohio United States 45219
    93 University of Cincinnati Medical Center/Research Office Cincinnati Ohio United States 45219
    94 University of Cincinnati Medical Center Cincinnati Ohio United States 45219
    95 University of Cincinnati Physicians Company LLC Cincinnati Ohio United States 45219
    96 University of Cincinnati- Hoxworth Building Cincinnati Ohio United States 45219
    97 UC Health Ridgeway Hospital Cincinnati Ohio United States 45229
    98 The Ohio State University Wexner Medical Center East Columbus Ohio United States 43203
    99 Nationwide Childrens Hospital Columbus Ohio United States 43205
    100 The Ohio State University Investigational Drug Services Columbus Ohio United States 43210
    101 The Ohio State University James Comprehensive Cancer Hospital & Solove Research Institute Columbus Ohio United States 43210
    102 The Ohio State University Wexner Medical Center Columbus Ohio United States 43210
    103 Five Rivers Medical Surgical Health Center Dayton Ohio United States 45402
    104 Miami Valley Hospital Dayton Ohio United States 45409
    105 Einstein Medical Center Philadelphia Philadelphia Pennsylvania United States 19141
    106 UPMC Presbyterian Pittsburgh Pennsylvania United States 15213
    107 Children's Hospital of Pittsburgh of UPMC Pittsburgh Pennsylvania United States 15224
    108 UPMC Hillman Cancer Center Pittsburgh Pennsylvania United States 15232
    109 Hasbro Children's Hospital Providence Rhode Island United States 02903
    110 Rhode Island Hospital-Pharmacy Service Providence Rhode Island United States 02903
    111 Rhode Island Hospital Providence Rhode Island United States 02903
    112 The Miriam Hospital Providence Rhode Island United States 02906
    113 Medical University of South Carolina - Hospital Charleston South Carolina United States 29425
    114 Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center Charleston South Carolina United States 29425
    115 Medical University of South Carolina Charleston South Carolina United States 29425
    116 MUSC Investigational Drug Services Charleston South Carolina United States 29425
    117 Cook Children's Hematology and Oncology Center Fort Worth Texas United States 76104
    118 Cook Children's Medical Center Fort Worth Texas United States 76104
    119 Cook Children's Hematology and Oncology Center-Grapevine Grapevine Texas United States 76051
    120 Texas Children's Hospital - Clinical Research Center Houston Texas United States 77030
    121 Texas Children´s Hospital Houston Texas United States 77030
    122 University of Texas Medical School Houston Texas United States 77030
    123 Primary Children's Hospital Salt Lake City Utah United States 84113
    124 Main Hospital - Virginia Commonwealth University Richmond Virginia United States 23298
    125 Virginia Commonwealth University-Investigational Drug Services Richmond Virginia United States 23298
    126 Virginia Commonwealth University Richmond Virginia United States 23298
    127 Royal Alexandra Hospital Edmonton Alberta Canada T5H 3V9
    128 Miseracordia Community Hospital Edmonton Alberta Canada T5R 4H5
    129 Kaye Edmonton Clinic 3 C Edmonton Alberta Canada T6G 1Z1
    130 University of Alberta Hospital, Pharmacy Services Edmonton Alberta Canada T6G 1Z1
    131 Stollery Children's Hospital Edmonton Alberta Canada T6G 2B7
    132 University of Alberta Hospital Edmonton Alberta Canada T6G 2B7
    133 Research transition Facility Edmonton Alberta Canada T6G 2V2
    134 Grey Nuns Community Hospital Edmonton Alberta Canada T6L 5X8
    135 St. Paul's Hospital Vancouver British Columbia Canada V6E 1M7
    136 St. Paul's Hospital Vancouver British Columbia Canada V6Z 1Y6
    137 Children's Hospital Of Eastern Ontario Ottawa Ontario Canada K1H 8L1
    138 University Health Network, Toronto General Hospital Toronto Ontario Canada M5G 2C4
    139 The Hospital for Sick Children Toronto Ontario Canada M5G1X8
    140 Centre Hospitalier Universitaire Sainte-Justine Montreal Quebec Canada H3T 1C5
    141 McGill University Health Centre, Royal Victoria Hospital Montreal Quebec Canada H4A 3J1
    142 The Montreal Children's Hospital/ McGill University Health Centre Montreal Quebec Canada H4A 3J1

    Sponsors and Collaborators

    • GlycoMimetics Incorporated

    Investigators

    • Study Director: Pfizer CT.gov Call Center, Pfizer

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    GlycoMimetics Incorporated
    ClinicalTrials.gov Identifier:
    NCT02187003
    Other Study ID Numbers:
    • B5201002
    • RESET
    First Posted:
    Jul 10, 2014
    Last Update Posted:
    Jun 22, 2020
    Last Verified:
    Jun 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    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:
    Anemia, Sickle Cell

    Study Results

    No Results Posted as of Jun 22, 2020