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

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NCT02187003

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Study Location
Miseracordia Community Hospital
Edmonton, Alberta, T5R 4H5, Canada
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Contact
1-800-718-1021
[email protected]
Related Links

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sickle Cell Anemia
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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Sickle Cell AnemiaEfficacy and Safety of Rivipansel (GMI-1070) in the Treatment of Vaso-Occlusive Crisis in Hospitalized Subjects With Sickle Cell Disease NCT02187003
  1. Edmonton, Alberta
  2. Augusta, Georgia
  3. Columbus, Ohio
  4. Pittsburgh, Pennsylvania
  5. Richmond, Virginia
  6. Cincinnati, Ohio
  7. Detroit, Michigan
  8. Detroit, Michigan
  9. Charleston, South Carolina
  10. Saint Louis, Missouri
  11. Chicago, Illinois
  12. Sacramento, California
  13. Ann Arbor, Michigan
  14. Baltimore, Maryland
  15. Savannah, Georgia
  16. Providence, Rhode Island
  17. Tampa, Florida
  18. Providence, Rhode Island
  19. Bronx, New York
  20. Charleston, South Carolina
  21. Washington, District of Columbia
  22. Houston, Texas
  23. Jackson, Mississippi
  24. Cincinnati, Ohio
  25. Tampa, Florida
  26. Kansas City, Missouri
  27. Atlanta, Georgia
  28. Saint Louis, Missouri
  29. Atlanta, Georgia
  30. Baltimore, Maryland
  31. Sacramento, California
  32. Providence, Rhode Island
  33. Pittsburgh, Pennsylvania
  34. Gainesville, Florida
  35. Montreal, Quebec
  36. Louisville, Kentucky
  37. Durham, North Carolina
  38. New Brunswick, New Jersey
  39. New York, New York
  40. Cincinnati, Ohio
  41. Aurora, Colorado
  42. Baltimore, Maryland
  43. Edmonton, Alberta
  44. Little Rock, Arkansas
  45. Louisville, Kentucky
  46. Savannah, Georgia
  47. Saint Louis, Missouri
  48. Columbus, Ohio
  49. Montreal, Quebec
  50. Baltimore, Maryland
  51. Dallas, Texas
  52. Fort Worth, Texas
  53. Baltimore, Maryland
  54. Boston, Massachusetts
  55. Columbus, Ohio
  56. Cincinnati, Ohio
  57. Houston, Texas
  58. West Palm Beach, Florida
  59. Vancouver, British Columbia
  60. Brooklyn, New York
  61. Cincinnati, Ohio
  62. Atlanta, Georgia
  63. Chicago, Illinois
  64. Gainesville, Florida
  65. Edmonton, Alberta
  66. Providence, Rhode Island
  67. Philadelphia, Pennsylvania
  68. Houston, Texas
  69. Fort Myers, Florida
  70. Washington, District of Columbia
  71. Aurora, Colorado
  72. Montreal, Quebec
  73. Washington, District of Columbia
  74. Edmonton, Alberta
  75. Atlanta, Georgia
  76. Boston, Massachusetts
  77. Brooklyn, New York
  78. Toronto, Ontario
  79. Grapevine, Texas
  80. Houston, Texas
  81. Little Rock, Arkansas
  82. Columbus, Ohio
  83. West Palm Beach, Florida
  84. Durham, North Carolina
  85. Baton Rouge, Louisiana
  86. Atlanta, Georgia
  87. Saint Louis, Missouri
  88. Gainesville, Florida
  89. Atlanta, Georgia
  90. Toronto, Ontario
  91. Miami, Florida
  92. Jackson, Mississippi
  93. Augusta, Georgia
  94. Greenville, North Carolina
  95. New York, New York
  96. Boston, Massachusetts
  97. Ottawa, Ontario
  98. Augusta, Georgia
  99. Boston, Massachusetts
  100. Edmonton, Alberta
  101. Philadelphia, Pennsylvania
  102. Baltimore, Maryland
  103. Cincinnati, Ohio
  104. Mobile, Alabama
  105. Greenville, North Carolina
  106. Greenville, North Carolina
  107. Brooklyn, New York
  108. Charleston, South Carolina
  109. Tampa, Florida
  110. Savannah, Georgia
  111. Edmonton, Alberta
  112. Columbus, Ohio
  113. Baton Rouge, Louisiana
  114. San Antonio, Texas
  115. Boston, Massachusetts
  116. Boston, Massachusetts
  117. Fort Worth, Texas
  118. Philadelphia, Pennsylvania
  119. Houston, Texas
  120. Chicago, Illinois
  121. Greenville, North Carolina
  122. Houston, Texas
  123. Tampa, Florida
  124. Charleston, South Carolina
  125. Louisville, Kentucky
  126. Edmonton, Alberta
  127. Louisville, Kentucky
  128. Richmond, Virginia
  129. Pittsburgh, Pennsylvania
  130. Sacramento, California
  131. New York, New York
  132. Brooklyn, New York
  133. Oakland, California
  134. Boston, Massachusetts
  135. Staten Island, New York
  136. Iowa City, Iowa
  137. Richmond, Virginia
  138. Miami, Florida
  139. Vancouver, British Columbia
  140. Salt Lake City, Utah
  141. Saint Louis, Missouri
  142. Houston, Texas
  143. Tampa, Florida
  144. New Brunswick, New Jersey
  145. New York, New York
  146. Chicago, Illinois
  147. Houston, Texas
  148. Edmonton, Alberta
  149. Detroit, Michigan
  150. New Brunswick, New Jersey
  151. Baton Rouge, Louisiana
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:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
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 May 2020

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