Study Stopped
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.
Safety of Rivipansel (GMI-1070) in the Treatment of One or More Vaso-Occlusive Crises in Hospitalized Subjects With Sickle Cell Disease
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
1 other identifier
interventional
154
2 countries
97
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Dec 2015
Typical duration for phase_3
97 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 29, 2015
CompletedFirst Posted
Study publicly available on registry
May 4, 2015
CompletedStudy Start
First participant enrolled
December 16, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 15, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 15, 2019
CompletedFebruary 10, 2021
February 1, 2021
3.9 years
April 29, 2015
February 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
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
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
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
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 Outcomes (1)
Subject re hospitalization
18 months
Study Arms (2)
Cohort 1
EXPERIMENTALIncludes one adult stratum (\>18 years old) and one pediatric stratum (12-17 years old). 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.
Cohort 2
EXPERIMENTALIncludes one pediatric stratum (6-11 years old). Subjects 6 to 11 years of age or subjects who weigh 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).
Interventions
Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (97)
University of South Alabama Women's and Children's Hospital
Mobile, Alabama, 36604, United States
Arkansas Children's Hospital Research Pharmacy
Little Rock, Arkansas, 72202, United States
Arkansas Children's Hospital
Little Rock, Arkansas, 72202, United States
UC Davis Medical Center Main Hospital
Sacramento, California, 95817, United States
University of California Davis Medical Center
Sacramento, California, 95817, United States
Howard University Center for Sickle Cell disease
Washington D.C., District of Columbia, 20001, United States
MedStar Health Research Institute
Washington D.C., District of Columbia, 20010, United States
Howard University Hospital
Washington D.C., District of Columbia, 20060, United States
Golisano Childrens Hospital of Southwest Florida
Fort Myers, Florida, 33908, United States
Jackson Memorial Hospital
Miami, Florida, 33136, United States
University of Miami
Miami, Florida, 33136, United States
St. Mary's Medical Center
West Palm Beach, Florida, 33407, United States
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center:
Atlanta, Georgia, 30303, United States
Grady Health System
Atlanta, Georgia, 30303, United States
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center:
Atlanta, Georgia, 30322, United States
Emory Children's Center
Atlanta, Georgia, 30322, United States
Children's Healthcare of Atlanta Aflac Cancer and Blood Disorders Center/
Atlanta, Georgia, 30342, United States
Children's Healthcare of Atlanta: Scottish Rite Campus
Atlanta, Georgia, 30342, United States
Memorial Family Medicine Center
Savannah, Georgia, 31404, United States
Memorial Health University Medical Center
Savannah, Georgia, 31404, United States
The University of Chicago/Comer Children's Hospital
Chicago, Illinois, 60637, United States
University of Chicago, Investigational Drug Service Pharmacy
Chicago, Illinois, 60637, United States
University of Maryland Medical System Investigational Pharmacy
Baltimore, Maryland, 21201, United States
University of Maryland Medical System
Baltimore, Maryland, 21201, United States
Johns Hopkins Department of Medicine Clinical Trials Unit
Baltimore, Maryland, 21205, United States
The Johns Hopkins University School of Medicine
Baltimore, Maryland, 21205, United States
The Johns Hopkins Hospital Department of Pharmacy Services
Baltimore, Maryland, 21287-6180, United States
Johns Hopkins Medicine
Baltimore, Maryland, 21287, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Center for Clinical Investigation, Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Investigational Drug Services
Boston, Massachusetts, 02115, United States
Children's Hospital of Michigan
Detroit, Michigan, 48201, United States
University of Mississippi Medical Center - Outpatient Clinical Research Unit
Jackson, Mississippi, 39216, United States
University of Mississippi Medical Center
Jackson, Mississippi, 39216, United States
Center for Outpatient Health
St Louis, Missouri, 63108, United States
Barnes-Jewish Hospital Department of Pharmacy
St Louis, Missouri, 63110, United States
Barnes-Jewish Hospital
St Louis, Missouri, 63110, United States
Center for Advanced Medicine
St Louis, Missouri, 63110, United States
Washington University School of Medicine
St Louis, Missouri, 63110, United States
Bristol Myers Squibb Children's Hospital at Robert Wood Johnson University Hospital
New Brunswick, New Jersey, 08901, United States
Rutgers-Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901, United States
Rutgers Cancer Institute of New Jersey
New Brunswick, New Jersey, 08903, United States
Kings County Hospital Center
Brooklyn, New York, 11203, United States
State University of New York (SUNY) Downstate Medical Center
Brooklyn, New York, 11203, United States
SUNY Downstate Medical Center University Hospital of Brooklyn
Brooklyn, New York, 11203, United States
Columbia University Medical Center Research Pharmacy
New York, New York, 10032, United States
MS CHONY Pediatric Emergency Department
New York, New York, 10032, United States
MS CHONY Pediatric Hematology/Oncology Unit
New York, New York, 10032, United States
Jacobi Medical Center
The Bronx, New York, 10461, United States
Duke University Hospital, Investigational Drug Service
Durham, North Carolina, 27710, United States
Duke University Medical Center
Durham, North Carolina, 27710, United States
East Carolina University Brody School of Medicine
Greenville, North Carolina, 27834, United States
East Carolina University, Brody School of Medicine
Greenville, North Carolina, 27834, United States
Leo W. Jenkins Cancer Center
Greenville, North Carolina, 27834, United States
Vidant Medical Center
Greenville, North Carolina, 27834, United States
University of Cincinnati - Hoxworth Building
Cincinnati, Ohio, 45219, United States
University of Cincinnati Medical Center / Investigational Pharmacy
Cincinnati, Ohio, 45219, United States
University of Cincinnati Medical Center / Research Office
Cincinnati, Ohio, 45219, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, 45219, United States
University of Cincinnati Physicians Company LLC
Cincinnati, Ohio, 45219, United States
UC Health Ridgeway Hospital
Cincinnati, Ohio, 45229, United States
The Ohio State University Investigational Drug Services
Columbus, Ohio, 43203, United States
The Ohio State University Wexner Center East
Columbus, Ohio, 43203, United States
The Ohio State University James Comprehensive Cancer Hospital & Solove Research Institute
Columbus, Ohio, 43210, United States
The Ohio State University Wexner Medical Center
Columbus, Ohio, 43210, United States
UPMC Presbyterian
Pittsburgh, Pennsylvania, 15213, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232, United States
Hasbro Children's Hospital
Providence, Rhode Island, 02903, United States
Rhode Island Hospital-Pharmacy Service
Providence, Rhode Island, 02903, United States
Rhode Island Hospital
Providence, Rhode Island, 02903, United States
The Miriam Hospital
Providence, Rhode Island, 02906, United States
Medical University of South Carolina Lifespan Comprehensive Sickle Cell Center
Charleston, South Carolina, 29425, United States
Medical University of South Carolina-Hospital
Charleston, South Carolina, 29425, United States
Medical University of South Carolina
Charleston, South Carolina, 29425, United States
MUSC Investigational Drug Services
Charleston, South Carolina, 29425, United States
Cook Children's Hematology and Oncology Center
Fort Worth, Texas, 76104, United States
Cook Children's Medical Center
Fort Worth, Texas, 76104, United States
Cook Children's Hematology and Oncology Center-Grapevine
Grapevine, Texas, 76051, United States
University of Texas Medical School
Houston, Texas, 77030, United States
Primary Children's Hospital Laboratory
Salt Lake City, Utah, 84113, United States
Primary Children's Hospital
Salt Lake City, Utah, 84113, United States
Main Hospital-VCU
Richmond, Virginia, 23298, United States
Virginia Commonwealth University - Investigational Drug Services
Richmond, Virginia, 23298, United States
Virginia Commonwealth University- Clinical Research Services Unit
Richmond, Virginia, 23298, United States
Royal Alexandra Hospital
Edmonton, Alberta, T5H 3V9, Canada
Miseracordia Community Hospital
Edmonton, Alberta, T5R 4H5, Canada
Kaye Edmonton Clinic 3C
Edmonton, Alberta, T6G 1Z1, Canada
University of Alberta Hospital, Pharmacy Services
Edmonton, Alberta, T6G 1Z1, Canada
Stollery Children's Hospital
Edmonton, Alberta, T6G 2B7, Canada
University of Alberta Hospital
Edmonton, Alberta, T6G 2B7, Canada
Research transition Facility
Edmonton, Alberta, T6G 2V2, Canada
Grey Nuns Community Hospital
Edmonton, Alberta, T6L 5X8, Canada
Children's Hospital of Eastern Ontario
Ottawa, Ontario, K1H 8L1, Canada
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8, Canada
Centre Hospitalier Universitaire Sainte-Justine
Montreal, Quebec, H3T 1C5, Canada
The Montreal Children's Hospital / McGill University Health Centre
Montreal, Quebec, H4A3J1, Canada
Related Publications (1)
Dampier CD, Telen MJ, Wun T, Brown RC, Desai P, El Rassi F, Fuh B, Kanter J, Pastore Y, Rothman J, Taylor JG, Readett D, Sivamurthy KM, Tammara B, Tseng LJ, Lozier JN, Thackray H, Magnani JL, Hassell KL; RESET Investigators. A randomized clinical trial of the efficacy and safety of rivipansel for sickle cell vaso-occlusive crisis. Blood. 2023 Jan 12;141(2):168-179. doi: 10.1182/blood.2022015797.
PMID: 35981565DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 29, 2015
First Posted
May 4, 2015
Study Start
December 16, 2015
Primary Completion
November 15, 2019
Study Completion
November 15, 2019
Last Updated
February 10, 2021
Record last verified: 2021-02
Data Sharing
- IPD Sharing
- Will not share