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Trial record 2 of 4 for:    Rivipansel | Sickle Cell Disease

Safety Of Rivipansel (GMI-1070) In The Treatment Of One or More Vaso-occlusive Crises In Hospitalized Subjects With Sickle Cell Disease

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ClinicalTrials.gov Identifier: NCT02433158
Recruitment Status : Recruiting
First Posted : May 4, 2015
Last Update Posted : May 9, 2018
Sponsor:
Information provided by (Responsible Party):
Pfizer

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).

Condition or disease Intervention/treatment Phase
Sickle Cell Anemia Sickle Cell Disease Sickle Cell Disorders Pain Crisis Vaso-occlusive Crisis Drug: Rivipansel Phase 3

Detailed 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: Non-Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 16, 2015
Estimated Primary Completion Date : October 9, 2018
Estimated Study Completion Date : July 15, 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Cohort 1
includes one adult stratum (>18 years old) and one pediatric stratum (12-17 years old)
Drug: Rivipansel
Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses. 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. Subjects 6 to 11 years of age or subject who weighs 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).
Other Name: GMI-1070
Experimental: Cohort 2
includes one pediatric stratum (6-11 years old).
Drug: Rivipansel
Rivipansel will be infused intravenously every 12 hours up to a maximum of 15 doses. 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. Subjects 6 to 11 years of age or subject who weighs 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).
Other Name: GMI-1070



Primary Outcome Measures :
  1. Number (%) of subjects with treatment emergent adverse events (TEAEs) over the study. [ Time Frame: 18 months ]
    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.

  2. Number (%) of subjects with adjudicated Acute Chest Syndrome (ACS) over the study. [ Time Frame: 18 months ]
    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.

  3. Number (%) of subjects with adjudicated severe and/or generalized cutaneous manifestations over the study [ Time Frame: 18 months ]
    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.

  4. Number (%) of subjects with serious adverse events (SAEs) over the study. [ Time Frame: 18 months ]
    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.


Secondary Outcome Measures :
  1. Subject re hospitalization [ Time Frame: 18 months ]
    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.



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Ages Eligible for Study:   6 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.


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): NCT02433158


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

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Locations
United States, Alabama
University of South Alabama Women's and Children's Hospital 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
University of California Davis Main Hospital Recruiting
Sacramento, California, United States, 95817
University of California Davis Medical Center Recruiting
Sacramento, California, United States, 95817
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
Uf Health Davis Cancer Pavilion 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
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: Scottish Rite Campus Recruiting
Atlanta, Georgia, United States, 30342
Department of Pediatric-Hematology-Oncology@ 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 Science Center Recruiting
Louisville, Kentucky, United States, 40202
University of Louisville Physicians Pediatric Hematology Oncology Recruiting
Louisville, Kentucky, United States, 40202
United States, Maryland
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 Department of Pharmacy Services 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 Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Center for Clinical Investigation, Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Investigational Drug Services Recruiting
Boston, Massachusetts, United States, 02115
United States, Michigan
Children's Hospital of Michigan Recruiting
Detroit, Michigan, United States, 48201
United States, Missouri
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 Recruiting
Brooklyn, New York, United States, 11203
State University of New York (SUNY) Downstate Medical Center Recruiting
Brooklyn, New York, United States, 11203
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
United States, North Carolina
Duke University Hospital, Investigational Drug Service Recruiting
Durham, North Carolina, United States, 27710
Duke University Hospital, lnvestigational Drug Service 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, Brody School of Medicine 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 Center East Recruiting
Columbus, Ohio, United States, 43203
Nationwide Children's 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 Recruiting
Dayton, Ohio, United States, 45402
Miami Valley Hospital Recruiting
Dayton, Ohio, United States, 45409
United States, Pennsylvania
The Children's Hospital of Philadelphia, Investigational Drug Service Recruiting
Philadelphia, Pennsylvania, United States, 19104
The Children's Hospital of Philadelphia Recruiting
Philadelphia, Pennsylvania, United States, 19104
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19134
St. Christopher's Hospital for Children Recruiting
Philadelphia, Pennsylvania, United States, 19140
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 Sickle Cell Clinic Recruiting
Charleston, South Carolina, United States, 29425
Medical University of South Carolina-Hospital 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
University of Texas Medical School Recruiting
Houston, Texas, United States, 77030
United States, Utah
Primary Children's Hospital Recruiting
Salt Lake City, Utah, United States, 84113
United States, Virginia
Virginia Commonwealth University - Investigational Drug Services Recruiting
Richmond, Virginia, United States, 23298
Virginia Commonwealth University- Clinical Research Services Unit Recruiting
Richmond, Virginia, United States, 23298
Canada, Alberta
University of Alberta Hospital, Pharmacy Services Recruiting
Edmonton, Alberta, Canada, T6G 1Z1
Stollery Children's Hospital Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Canada, Ontario
Children's Hospital of Eastern Ontario Recruiting
Ottawa, Ontario, Canada, K1H 8L1
The Hospital for Sick Children Recruiting
Toronto, Ontario, Canada, M5G 1X8
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: NCT02433158     History of Changes
Other Study ID Numbers: B5201003
First Posted: May 4, 2015    Key Record Dates
Last Update Posted: May 9, 2018
Last Verified: May 2018

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

Keywords provided by Pfizer:
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