Anemia, Sickle Cell Clinical Trial
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
| Verified date | June 2020 |
| Source | GlycoMimetics Incorporated |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 345 |
| Est. completion date | June 25, 2019 |
| Est. primary completion date | May 3, 2019 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 6 Years and older |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Grey Nuns Community Hospital | Edmonton | Alberta |
| Canada | Kaye Edmonton Clinic 3 C | Edmonton | Alberta |
| Canada | Miseracordia Community Hospital | Edmonton | Alberta |
| Canada | Research transition Facility | Edmonton | Alberta |
| Canada | Royal Alexandra Hospital | Edmonton | Alberta |
| Canada | Stollery Children's Hospital | Edmonton | Alberta |
| Canada | University of Alberta Hospital | Edmonton | Alberta |
| Canada | University of Alberta Hospital, Pharmacy Services | Edmonton | Alberta |
| Canada | Centre Hospitalier Universitaire Sainte-Justine | Montreal | Quebec |
| Canada | McGill University Health Centre, Royal Victoria Hospital | Montreal | Quebec |
| Canada | The Montreal Children's Hospital/ McGill University Health Centre | Montreal | Quebec |
| Canada | Children's Hospital Of Eastern Ontario | Ottawa | Ontario |
| Canada | The Hospital for Sick Children | Toronto | Ontario |
| Canada | University Health Network, Toronto General Hospital | Toronto | Ontario |
| Canada | St. Paul's Hospital | Vancouver | British Columbia |
| Canada | St. Paul's Hospital | Vancouver | British Columbia |
| United States | Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center | Atlanta | Georgia |
| United States | Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center | Atlanta | Georgia |
| United States | Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center | Atlanta | Georgia |
| United States | Children's Healthcare of Atlanta: Scottish Rite Campus | Atlanta | Georgia |
| United States | Emory Children's Center | Atlanta | Georgia |
| United States | Grady Health System | Atlanta | Georgia |
| United States | Augusta University | Augusta | Georgia |
| United States | Augusta University Clinical Research Pharmacy | Augusta | Georgia |
| United States | Augusta University Medical Center | Augusta | Georgia |
| United States | University of Colorado CTRC | Aurora | Colorado |
| United States | University of Colorado Hospital | Aurora | Colorado |
| United States | Johns Hopkins Medicine | Baltimore | Maryland |
| United States | Johns Hopkins Medicine | Baltimore | Maryland |
| United States | The Johns Hopkins Hospital | Baltimore | Maryland |
| United States | The Johns Hopkins University School of Medicine | Baltimore | Maryland |
| United States | University of Maryland Medical System | Baltimore | Maryland |
| United States | University of Maryland Medical System Investigational Pharmacy | Baltimore | Maryland |
| United States | Our Lady of the Lake Physician Group-Medical Oncology | Baton Rouge | Louisiana |
| United States | Our Lady of the Lake Regional Medical Center | Baton Rouge | Louisiana |
| United States | St. Jude Affiliate Clinic | Baton Rouge | Louisiana |
| United States | Boston Children's Hospital | Boston | Massachusetts |
| United States | Boston Medical Center | Boston | Massachusetts |
| United States | Boston Medical Center E7E | Boston | Massachusetts |
| United States | Boston University Medical Center | Boston | Massachusetts |
| United States | Brigham and Womens Hospital | Boston | Massachusetts |
| United States | Center for Clinical Investigation, Brigham & Women's Hospital | Boston | Massachusetts |
| United States | Investigational Drug Services | Boston | Massachusetts |
| United States | Jacobi Medical Center | Bronx | New York |
| United States | Kings County Hospital Center | Brooklyn | New York |
| United States | Kings County Hospital Center - Pharmacy Department | Brooklyn | New York |
| United States | State University of New York (SUNY) - Downstate Medical Center | Brooklyn | New York |
| United States | SUNY Downstate Medical Center University Hospital of Brooklyn | Brooklyn | New York |
| United States | Medical University of South Carolina | Charleston | South Carolina |
| United States | Medical University of South Carolina - Hospital | Charleston | South Carolina |
| United States | Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center | Charleston | South Carolina |
| United States | MUSC Investigational Drug Services | Charleston | South Carolina |
| United States | The University of Chicago/Comer Children's Hospital | Chicago | Illinois |
| United States | University of Chicago, Investigational Drug Service Pharmacy | Chicago | Illinois |
| United States | University of Illinois at Chicago Clinical Research Center | Chicago | Illinois |
| United States | University of Illinois Hospital and Health Sciences System | Chicago | Illinois |
| United States | UC Health Ridgeway Hospital | Cincinnati | Ohio |
| United States | University of Cincinnati Medical Center | Cincinnati | Ohio |
| United States | University of Cincinnati Medical Center/ Investigational Pharmacy | Cincinnati | Ohio |
| United States | University of Cincinnati Medical Center/Research Office | Cincinnati | Ohio |
| United States | University of Cincinnati Physicians Company LLC | Cincinnati | Ohio |
| United States | University of Cincinnati- Hoxworth Building | Cincinnati | Ohio |
| United States | Nationwide Childrens Hospital | Columbus | Ohio |
| United States | The Ohio State University Investigational Drug Services | Columbus | Ohio |
| United States | The Ohio State University James Comprehensive Cancer Hospital & Solove Research Institute | Columbus | Ohio |
| United States | The Ohio State University Wexner Medical Center | Columbus | Ohio |
| United States | The Ohio State University Wexner Medical Center East | Columbus | Ohio |
| United States | Five Rivers Medical Surgical Health Center | Dayton | Ohio |
| United States | Miami Valley Hospital | Dayton | Ohio |
| United States | Children's Hospital of Michigan | Detroit | Michigan |
| United States | Detroit Medical Center Pharmacy | Detroit | Michigan |
| United States | Wayne State University / Detroit Receiving Hospital | Detroit | Michigan |
| United States | Duke University Hospital | Durham | North Carolina |
| United States | Duke University Medical Center | Durham | North Carolina |
| United States | Golisano Children's Hospital of Southwest Florida | Fort Myers | Florida |
| United States | Cook Children's Hematology and Oncology Center | Fort Worth | Texas |
| United States | Cook Children's Medical Center | Fort Worth | Texas |
| United States | UF Health Davis Cancer Pavillion and Shands Med Plaza | Gainesville | Florida |
| United States | UF Health Shands Cancer Hospital | Gainesville | Florida |
| United States | UF Health Shands Hospital | Gainesville | Florida |
| United States | Cook Children's Hematology and Oncology Center-Grapevine | Grapevine | Texas |
| United States | East Carolina University Brody School of Medicine | Greenville | North Carolina |
| United States | Leo W. Jenkins Cancer Center | Greenville | North Carolina |
| United States | Vidant Medical Center | Greenville | North Carolina |
| United States | Texas Children's Hospital - Clinical Research Center | Houston | Texas |
| United States | Texas Children´s Hospital | Houston | Texas |
| United States | University of Texas Medical School | Houston | Texas |
| United States | University of Iowa Hospitals and Clinics | Iowa City | Iowa |
| United States | University Of Mississippi Medical Center | Jackson | Mississippi |
| United States | University of Mississippi Medical Center-Outpatient Clinical Research Unit | Jackson | Mississippi |
| United States | Children's Mercy Hospital | Kansas City | Missouri |
| United States | Arkansas Children's Hospital | Little Rock | Arkansas |
| United States | Arkansas Children's Hospital Research Pharmacy | Little Rock | Arkansas |
| United States | Kosair Charities Pediatric Clinical Research Unit | Louisville | Kentucky |
| United States | Norton Children´s Hospital | Louisville | Kentucky |
| United States | The Novak Center for Children's Health | Louisville | Kentucky |
| United States | University of Louisville Health Sciences Center | Louisville | Kentucky |
| United States | University of Louisville Physicians Pediatric Hematology Oncology | Louisville | Kentucky |
| United States | Jackson Memorial Hospital | Miami | Florida |
| United States | University Of Miami | Miami | Florida |
| United States | University of South Alabama Children's and Women's Hospital | Mobile | Alabama |
| United States | Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital | New Brunswick | New Jersey |
| United States | Rutgers Cancer Institute Of New Jersey | New Brunswick | New Jersey |
| United States | Rutgers-Robert Wood Johnson Medical School | New Brunswick | New Jersey |
| United States | Columbia University Medical Center Research Pharmacy | New York | New York |
| United States | Icahn School of Medicine at Mount Sinai | New York | New York |
| United States | MS CHONY Pediatric Emergency Department | New York | New York |
| United States | MS CHONY Pediatric Hematology/Oncology Unit | New York | New York |
| United States | UCSF Benioff Children's Hospital Oakland | Oakland | California |
| United States | Einstein Medical Center Philadelphia | Philadelphia | Pennsylvania |
| United States | Children's Hospital of Pittsburgh of UPMC | Pittsburgh | Pennsylvania |
| United States | UPMC Hillman Cancer Center | Pittsburgh | Pennsylvania |
| United States | UPMC Presbyterian | Pittsburgh | Pennsylvania |
| United States | Hasbro Children's Hospital | Providence | Rhode Island |
| United States | Rhode Island Hospital | Providence | Rhode Island |
| United States | Rhode Island Hospital-Pharmacy Service | Providence | Rhode Island |
| United States | The Miriam Hospital | Providence | Rhode Island |
| United States | Main Hospital - Virginia Commonwealth University | Richmond | Virginia |
| United States | Virginia Commonwealth University | Richmond | Virginia |
| United States | Virginia Commonwealth University-Investigational Drug Services | Richmond | Virginia |
| United States | UC Davis Medical Center | Sacramento | California |
| United States | UC Davis Medical Center Main Hospital | Sacramento | California |
| United States | University of California Davis Medical Center | Sacramento | California |
| United States | Barnes-Jewish Hospital | Saint Louis | Missouri |
| United States | Barnes-Jewish Hospital Department of Pharmacy | Saint Louis | Missouri |
| United States | Center for Advanced Medicine | Saint Louis | Missouri |
| United States | Center for Outpatient Health | Saint Louis | Missouri |
| United States | Washington University School of Medicine | Saint Louis | Missouri |
| United States | Primary Children's Hospital | Salt Lake City | Utah |
| United States | Memorial Family Medicine Ctr. @Memorial Health Univ Med Ct | Savannah | Georgia |
| United States | Memorial Health University Medical Center | Savannah | Georgia |
| United States | Staten Island University Hospital | Staten Island | New York |
| United States | Investigational Drug Service Tampa General Hospital | Tampa | Florida |
| United States | St. Joseph's Children's Hospital | Tampa | Florida |
| United States | Tampa General Hospital | Tampa | Florida |
| United States | Tampa General Hospital Center of Research Excellence | Tampa | Florida |
| United States | University of South Florida | Tampa | Florida |
| United States | Howard University Center for Sickle Cell Disease | Washington | District of Columbia |
| United States | Howard University Hospital | Washington | District of Columbia |
| United States | Medstar Health Research Institute | Washington | District of Columbia |
| United States | Children's Hematology and Oncology Associates | West Palm Beach | Florida |
| United States | St. Mary's Medical Center | West Palm Beach | Florida |
| Lead Sponsor | Collaborator |
|---|---|
| GlycoMimetics Incorporated |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Time to readiness-for-discharge. | 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. | Assessments will be every 4 hours (from 6am to 10pm, daily) for the duration of hospitalization, an expected average of 5 days | |
| Secondary | Time to discharge. | 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. | Participants will be followed for the duration of hospital stay, an expected average of 5 days | |
| Secondary | Cumulative IV opioid consumption from the time of the loading dose of study drug to discharge. | 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 | |
| Secondary | Time to discontinuation of IV opioids. | Time to discontinuation of IV opioids. | Participants will be followed for the duration of hospital stay, an expected average of 5 days | |
| Secondary | Cumulative IV opioid consumption within the first 24 hours post-loading dose of study drug. | Cumulative IV opioid consumption within the first 24 hours post-loading dose of study drug. | Day 1 | |
| Secondary | Percent of subjects re-hospitalized for VOC within 3 days of discharge. | Percent of subjects re-hospitalized for VOC within 3 days of discharge. | Within 3 days of discharge |
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