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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02433158
Other study ID # B5201003
Secondary ID
Status Terminated
Phase Phase 3
First received
Last updated
Start date December 16, 2015
Est. completion date November 15, 2019

Study information

Verified date February 2021
Source GlycoMimetics Incorporated
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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.


Recruitment information / eligibility

Status Terminated
Enrollment 154
Est. completion date November 15, 2019
Est. primary completion date November 15, 2019
Accepts healthy volunteers No
Gender All
Age group 6 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Rivipansel
Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.

Locations

Country Name City State
Canada Grey Nuns Community Hospital Edmonton Alberta
Canada Kaye Edmonton Clinic 3C 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 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
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 Johns Hopkins Department of Medicine Clinical Trials Unit Baltimore Maryland
United States Johns Hopkins Medicine Baltimore Maryland
United States The Johns Hopkins Hospital Department of Pharmacy Services 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 Boston Children's Hospital Boston Massachusetts
United States Brigham and Women's Hospital Boston Massachusetts
United States Center for Clinical Investigation, Brigham and 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 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 Lifespan Comprehensive Sickle Cell Center Charleston South Carolina
United States Medical University of South Carolina-Hospital 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 UC Health Ridgeway Hospital Cincinnati Ohio
United States University of Cincinnati - Hoxworth Building 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 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 Center East Columbus Ohio
United States The Ohio State University Wexner Medical Center Columbus Ohio
United States Children's Hospital of Michigan Detroit Michigan
United States Duke University Hospital, Investigational Drug Service Durham North Carolina
United States Duke University Medical Center Durham North Carolina
United States Golisano Childrens 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 Cook Children's Hematology and Oncology Center-Grapevine Grapevine Texas
United States East Carolina University Brody School of Medicine Greenville North Carolina
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 University of Texas Medical School Houston Texas
United States University of Mississippi Medical Center Jackson Mississippi
United States University of Mississippi Medical Center - Outpatient Clinical Research Unit Jackson Mississippi
United States Arkansas Children's Hospital Little Rock Arkansas
United States Arkansas Children's Hospital Research Pharmacy Little Rock Arkansas
United States Jackson Memorial Hospital Miami Florida
United States University of Miami Miami Florida
United States University of South Alabama Women's and Children'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 MS CHONY Pediatric Emergency Department New York New York
United States MS CHONY Pediatric Hematology/Oncology Unit New York New York
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-VCU Richmond Virginia
United States Virginia Commonwealth University - Investigational Drug Services Richmond Virginia
United States Virginia Commonwealth University- Clinical Research Services Unit Richmond Virginia
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 Primary Children's Hospital Laboratory Salt Lake City Utah
United States Memorial Family Medicine Center Savannah Georgia
United States Memorial Health University Medical Center Savannah Georgia
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 St. Mary's Medical Center West Palm Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
GlycoMimetics Incorporated

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study. 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. 18 months
Primary Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study. 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. 18 months
Primary Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study 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. 18 months
Primary Number (%) of subjects with serious adverse events (SAEs) over the study. 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. 18 months
Secondary Subject re hospitalization 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. 18 months
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