Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease

NCT02187003

Last updated date
Study Location
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Anemia, Sickle Cell
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
6 + years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- 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
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- 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

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Anemia, Sickle CellEfficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
NCT02187003
  1. Iowa City, Iowa
  2. Ann Arbor, Michigan
  3. Houston, Texas
  4. Mobile, Alabama
  5. Little Rock, Arkansas
  6. Little Rock, Arkansas
  7. Oakland, California
  8. Sacramento, California
  9. Sacramento, California
  10. Sacramento, California
  11. Aurora, Colorado
  12. Aurora, Colorado
  13. Washington, District of Columbia
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  16. Fort Myers, Florida
  17. Gainesville, Florida
  18. Gainesville, Florida
  19. Gainesville, Florida
  20. Miami, Florida
  21. Miami, Florida
  22. Tampa, Florida
  23. Tampa, Florida
  24. Tampa, Florida
  25. Tampa, Florida
  26. Tampa, Florida
  27. West Palm Beach, Florida
  28. West Palm Beach, Florida
  29. Atlanta, Georgia
  30. Atlanta, Georgia
  31. Atlanta, Georgia
  32. Atlanta, Georgia
  33. Atlanta, Georgia
  34. Atlanta, Georgia
  35. Augusta, Georgia
  36. Augusta, Georgia
  37. Augusta, Georgia
  38. Savannah, Georgia
  39. Savannah, Georgia
  40. Savannah, Georgia
  41. Chicago, Illinois
  42. Chicago, Illinois
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  45. Louisville, Kentucky
  46. Louisville, Kentucky
  47. Louisville, Kentucky
  48. Louisville, Kentucky
  49. Baton Rouge, Louisiana
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  69. Jackson, Mississippi
  70. Kansas City, Missouri
  71. Saint Louis, Missouri
  72. Saint Louis, Missouri
  73. Saint Louis, Missouri
  74. Saint Louis, Missouri
  75. Saint Louis, Missouri
  76. New Brunswick, New Jersey
  77. New Brunswick, New Jersey
  78. New Brunswick, New Jersey
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  80. Brooklyn, New York
  81. Brooklyn, New York
  82. Brooklyn, New York
  83. Brooklyn, New York
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  86. New York, New York
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  88. Staten Island, New York
  89. Durham, North Carolina
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  109. Pittsburgh, Pennsylvania
  110. Pittsburgh, Pennsylvania
  111. Pittsburgh, Pennsylvania
  112. Providence, Rhode Island
  113. Providence, Rhode Island
  114. Providence, Rhode Island
  115. Providence, Rhode Island
  116. Charleston, South Carolina
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  150. Montreal, Quebec
  151. Montreal, Quebec
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Anemia, Sickle Cell
Intervention  ICMJE
  • 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
  • Other: Placebo
    Placebo (phosphate buffered saline) will be infused intravenously every 12 hours up to 15 doses maximum.
    Other Name: phosphate buffered saline
Study Arms  ICMJE
  • Experimental: Rivipansel Treatment Arm
    Intervention: Drug: Rivipansel
  • Placebo Comparator: Placebo Treatment Arm
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 10, 2019)
345
Original Estimated Enrollment  ICMJE
 (submitted: July 7, 2014)
350
Actual Study Completion Date  ICMJE June 25, 2019
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 6 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02187003
Other Study ID Numbers  ICMJE B5201002
RESET ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD:No
Responsible Party GlycoMimetics Incorporated
Study Sponsor  ICMJE GlycoMimetics Incorporated
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account GlycoMimetics Incorporated
Verification Date June 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP