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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02187003
Recruitment Status : Recruiting
First Posted : July 10, 2014
Last Update Posted : July 13, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 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 8, 2015
Estimated Primary Completion Date : November 6, 2018
Estimated Study Completion Date : November 6, 2018

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.


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


Contacts
Contact: Pfizer CT.gov Call Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

  Hide Study Locations
Locations
United States, Alabama
University of South Alabama Children's and Women's Hospital Active, not recruiting
Mobile, Alabama, United States, 36604
United States, Arkansas
Arkansas Children's Hospital Research Pharmacy Recruiting
Little Rock, Arkansas, United States, 72202
Arkansas Children's Hospital Recruiting
Little Rock, Arkansas, United States, 72202
United States, California
UCSF Benioff Children's Hospital Oakland Recruiting
Oakland, California, United States, 94609
UC Davis Medical Center Main Hospital Recruiting
Sacramento, California, United States, 95817
UC Davis Medical Center Recruiting
Sacramento, California, United States, 95817
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
United States, Colorado
University of Colorado CTRC Recruiting
Aurora, Colorado, United States, 80045
University of Colorado Hospital Recruiting
Aurora, Colorado, United States, 80045
United States, District of Columbia
Medstar Health Research Institute Recruiting
Washington, District of Columbia, United States, 20010
Howard University Hospital Recruiting
Washington, District of Columbia, United States, 20060
United States, Florida
Golisano Children's Hospital of Southwest Florida Recruiting
Fort Myers, Florida, United States, 33908
UF Health Davis Cancer Pavillion and Shands Med Plaza Recruiting
Gainesville, Florida, United States, 32608
UF Health Shands Cancer Hospital Recruiting
Gainesville, Florida, United States, 32608
UF Health Shands Hospital Recruiting
Gainesville, Florida, United States, 32610
Jackson Memorial Hospital Recruiting
Miami, Florida, United States, 33136
University Of Miami Recruiting
Miami, Florida, United States, 33136
Investigational Drug Service Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
Tampa General Hospital Center of Research Excellence Recruiting
Tampa, Florida, United States, 33606
Tampa General Hospital Recruiting
Tampa, Florida, United States, 33606
University of South Florida Recruiting
Tampa, Florida, United States, 33606
St. Joseph's Children's Hospital Recruiting
Tampa, Florida, United States, 33607
Children's Hematology and Oncology Associates Recruiting
West Palm Beach, Florida, United States, 33407
St. Mary's Medical Center Recruiting
West Palm Beach, Florida, United States, 33407
United States, Georgia
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center Recruiting
Atlanta, Georgia, United States, 30303
Grady Health System Recruiting
Atlanta, Georgia, United States, 30303
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center Recruiting
Atlanta, Georgia, United States, 30322
Emory Children's Center Recruiting
Atlanta, Georgia, United States, 30322
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center Recruiting
Atlanta, Georgia, United States, 30342
Children's Healthcare of Atlanta: Recruiting
Atlanta, Georgia, United States, 30342
Augusta University Clinical Research Pharmacy Recruiting
Augusta, Georgia, United States, 30912
Augusta University Medical Center Recruiting
Augusta, Georgia, United States, 30912
Augusta University Recruiting
Augusta, Georgia, United States, 30912
Department of Pediatric-Hematology-Oncology@ The Dwaine & Cynthia Willett Recruiting
Savannah, Georgia, United States, 31404
Memorial Family Medicine Center Recruiting
Savannah, Georgia, United States, 31404
Memorial Health University Medical Center Recruiting
Savannah, Georgia, United States, 31404
United States, Illinois
The University of Chicago/Comer Children's Hospital Recruiting
Chicago, Illinois, United States, 60637
University of Chicago, Investigational Drug Service Pharmacy Recruiting
Chicago, Illinois, United States, 60637
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit Recruiting
Louisville, Kentucky, United States, 40202
Norton Children´s Hospital Recruiting
Louisville, Kentucky, United States, 40202
University of Louisville Health Sciences Center Recruiting
Louisville, Kentucky, United States, 40202
University of Louisville Physicians Pediatric Hematology Oncology Recruiting
Louisville, Kentucky, United States, 40202
United States, Louisiana
Our Lady of the Lake Regional Medical Center (Inpatient and Pharmacy for IP shipment) Recruiting
Baton Rouge, Louisiana, United States, 70808
St. Jude Affiliate Clinic Recruiting
Baton Rouge, Louisiana, United States, 70808
Our Lady of the Lake Physician Group-Medical Oncology Recruiting
Baton Rouge, Louisiana, United States, 70809
United States, Maryland
University of Maryland Medical System Investigational Pharmacy Recruiting
Baltimore, Maryland, United States, 21201
University of Maryland Medical System Recruiting
Baltimore, Maryland, United States, 21201
Johns Hopkins Medicine Recruiting
Baltimore, Maryland, United States, 21205
The Johns Hopkins University School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
The Johns Hopkins Hospital Recruiting
Baltimore, Maryland, United States, 21287-6180
Johns Hopkins Medicine Recruiting
Baltimore, Maryland, United States, 21287
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Brigham and Womens Hospital Recruiting
Boston, Massachusetts, United States, 02115
Center for Clinical Investigation, Brigham & Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Investigational Drug Services Recruiting
Boston, Massachusetts, United States, 02115
Boston Medical Center E7E Recruiting
Boston, Massachusetts, United States, 02118
Boston Medical Center Recruiting
Boston, Massachusetts, United States, 02118
Boston University Medical Center Recruiting
Boston, Massachusetts, United States, 02118
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
United States, Mississippi
University of Mississippi Medical Center-Outpatient Clinical Research Unit Recruiting
Jackson, Mississippi, United States, 39216
University Of Mississippi Medical Center Recruiting
Jackson, Mississippi, United States, 39216
United States, Missouri
Children´s Mercy Hospital Recruiting
Kansas City, Missouri, United States, 64108
Center for Outpatient Health Recruiting
Saint Louis, Missouri, United States, 63108
Barnes-Jewish Hospital Department of Pharmacy Recruiting
Saint Louis, Missouri, United States, 63110
Barnes-Jewish Hospital Recruiting
Saint Louis, Missouri, United States, 63110
Center for Advanced Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
United States, New Jersey
Cooper University Hospital Recruiting
Camden, New Jersey, United States, 08103
Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital Recruiting
New Brunswick, New Jersey, United States, 08901
Rutgers-Robert Wood Johnson Medical School Recruiting
New Brunswick, New Jersey, United States, 08901
Rutgers Cancer Institute Of New Jersey Recruiting
New Brunswick, New Jersey, United States, 08903
United States, New York
Jacobi Medical Center Recruiting
Bronx, New York, United States, 10461
Downstate Medical Center State Univ of NY HLTH SCI CTR PHMCY Recruiting
Brooklyn, New York, United States, 11203
Kings County Hospital Center - Pharmacy Department Recruiting
Brooklyn, New York, United States, 11203
Kings County Hospital Center Recruiting
Brooklyn, New York, United States, 11203
State University of New York (SUNY) - Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
Icahn School of Medicine at Mount Sinai Recruiting
New York, New York, United States, 10029
Columbia University Medical Center Research Pharmacy Recruiting
New York, New York, United States, 10032
MS CHONY Pediatric Emergency Department Recruiting
New York, New York, United States, 10032
MS CHONY Pediatric Hematology/Oncology Unit Recruiting
New York, New York, United States, 10032
Staten Island University Hospital Not yet recruiting
Staten Island, New York, United States, 10305
United States, North Carolina
Investigational Drug Service, UNC Hospitals Recruiting
Chapel Hill, North Carolina, United States, 27514
UNC Hospitals/UNC Healthcare Recruiting
Chapel Hill, North Carolina, United States, 27514
Clinical and Translational Research Center (CTRC) Recruiting
Chapel Hill, North Carolina, United States, 27599
Duke University Hospital Recruiting
Durham, North Carolina, United States, 27710
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
East Carolina University Brody School of Medicine Recruiting
Greenville, North Carolina, United States, 27834
East Carolina University Recruiting
Greenville, North Carolina, United States, 27834
Leo W. Jenkins Cancer Center Recruiting
Greenville, North Carolina, United States, 27834
Vidant Medical Center Recruiting
Greenville, North Carolina, United States, 27834
United States, Ohio
The Ohio State University Wexner Medical Center East Recruiting
Columbus, Ohio, United States, 43203
Nationwide Childrens Hospital Recruiting
Columbus, Ohio, United States, 43205
The Ohio State University Investigational Drug Services Recruiting
Columbus, Ohio, United States, 43210
The Ohio State University James Comprehensive Cancer Hospital & Solove Research Institute Recruiting
Columbus, Ohio, United States, 43210
The Ohio State University Wexner Medical Center Recruiting
Columbus, Ohio, United States, 43210
Five Rivers Medical Surgical Health Center Terminated
Dayton, Ohio, United States, 45402
Miami Valley Hospital Terminated
Dayton, Ohio, United States, 45409
United States, Pennsylvania
Children's Hospital of Philadelphia, Investigational Drug Service Recruiting
Philadelphia, Pennsylvania, United States, 19104
Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
St. Christopher's Hospital for Children - Department of Pharmacy Recruiting
Philadelphia, Pennsylvania, United States, 19134
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19140
Einstein Medical Center Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19141
UPMC Presbyterian Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Children's Hospital of Pittsburgh of UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15224
UPMC Hillman Cancer Center Recruiting
Pittsburgh, Pennsylvania, United States, 15232
United States, South Carolina
Medical University of South Carolina - Hospital Recruiting
Charleston, South Carolina, United States, 29425
Medical University of South Carolina Lifespan Comprehensive Sickle Cell Clinic Recruiting
Charleston, South Carolina, United States, 29425
Medical University of South Carolina Recruiting
Charleston, South Carolina, United States, 29425
MUSC Investigational Drug Services Recruiting
Charleston, South Carolina, United States, 29425
United States, Texas
Children's Medical Center Recruiting
Dallas, Texas, United States, 75235
Cook Children's Hematology and Oncology Center Recruiting
Fort Worth, Texas, United States, 76104
Cook Children's Medical Center Recruiting
Fort Worth, Texas, United States, 76104
Cook Children's Hematology and Oncology Center-Grapevine Recruiting
Grapevine, Texas, United States, 76051
UT Physicians Comprehensive Sickle Cell Center Houston Recruiting
Houston, Texas, United States, 77004
Memorial Hermann - TMC Investigational Drugs, IDS Pharmacy Recruiting
Houston, Texas, United States, 77030
Memorial Hermann Hospital, Texas Medical Center - Clinical Research Unit (CRU) Recruiting
Houston, Texas, United States, 77030
Memorial Hermann/UT Cancer Center - Texas Medical Center Recruiting
Houston, Texas, United States, 77030
Texas Children´s Hospital - Clinical Care Center Recruiting
Houston, Texas, United States, 77030
Texas Children´s Hospital - Investigational Pharmacy Recruiting
Houston, Texas, United States, 77030
Texas Children´s Hospital - Main Hospital Recruiting
Houston, Texas, United States, 77030
University of Texas Medical School Recruiting
Houston, Texas, United States, 77030
The Childrens Hospital of San Antonio Recruiting
San Antonio, Texas, United States, 78207
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
United States, Virginia
Main Hospital - Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Virginia Commonwealth University-Investigational Drug Services Recruiting
Richmond, Virginia, United States, 23298
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Canada, Alberta
Royal Alexandra Hospital Recruiting
Edmonton, Alberta, Canada, T5H 3V9
Miseracordia Community Hospital Recruiting
Edmonton, Alberta, Canada, T5R 4H5
Kaye Edmonton Clinic 3 C Recruiting
Edmonton, Alberta, Canada, T6G 1Z1
University of Alberta Hospital, Pharmacy Services Recruiting
Edmonton, Alberta, Canada, T6G 1Z1
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
University of Alberta Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Research transition Facility Recruiting
Edmonton, Alberta, Canada, T6G 2V2
Grey Nuns Community Hospital Recruiting
Edmonton, Alberta, Canada, T6L 5X8
Canada, Ontario
Children's Hospital Of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
University Health Network, Toronto General Hospital Recruiting
Toronto, Ontario, Canada, M5G 2C4
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G1X8
Canada, Quebec
Centre Hospitalier Universitaire Sainte-Justine Recruiting
Montreal, Quebec, Canada, H3T 1C5
Sponsors and Collaborators
Pfizer
Investigators
Study Director: Pfizer CT.gov Call Center Pfizer

Additional Information:
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT02187003     History of Changes
Other Study ID Numbers: B5201002
First Posted: July 10, 2014    Key Record Dates
Last Update Posted: July 13, 2018
Last Verified: July 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Pfizer:
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
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn