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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NCT02433158

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Study Location
University of Cincinnati - Hoxworth Building
Cincinnati, Ohio, 45219, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive Crisis
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

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

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.

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Sickle Cell Anemia, Sickle Cell Disease, Sickle Cell Disorders, Pain Crisis, Vaso-occlusive CrisisSafety Of Rivipansel (GMI-1070) In The Treatment Of One or More Vaso-occlusive Crises In Hospitalized Subjects With Sickle Cell Disease
NCT02433158
  1. Cincinnati, Ohio
  2. Mobile, Alabama
  3. Little Rock, Arkansas
  4. Little Rock, Arkansas
  5. Oakland, California
  6. Sacramento, California
  7. Sacramento, California
  8. Washington, District of Columbia
  9. Washington, District of Columbia
  10. Washington, District of Columbia
  11. Fort Myers, Florida
  12. Miami, Florida
  13. Miami, Florida
  14. Tampa, Florida
  15. Tampa, Florida
  16. Tampa, Florida
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  18. Tampa, Florida
  19. West Palm Beach, Florida
  20. Atlanta, Georgia
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  22. Atlanta, Georgia
  23. Atlanta, Georgia
  24. Atlanta, Georgia
  25. Atlanta, Georgia
  26. Savannah, Georgia
  27. Savannah, Georgia
  28. Savannah, Georgia
  29. Chicago, Illinois
  30. Chicago, Illinois
  31. Louisville, Kentucky
  32. Louisville, Kentucky
  33. Louisville, Kentucky
  34. Louisville, Kentucky
  35. Louisville, Kentucky
  36. Louisville, Kentucky
  37. Baltimore, Maryland
  38. Boston, Massachusetts
  39. Boston, Massachusetts
  40. Boston, Massachusetts
  41. Boston, Massachusetts
  42. Detroit, Michigan
  43. Jackson, Mississippi
  44. Jackson, Mississippi
  45. Saint Louis, Missouri
  46. Saint Louis, Missouri
  47. Saint Louis, Missouri
  48. Saint Louis, Missouri
  49. New Brunswick, New Jersey
  50. New Brunswick, New Jersey
  51. New Brunswick, New Jersey
  52. Bronx, New York
  53. Brooklyn, New York
  54. Brooklyn, New York
  55. Brooklyn, New York
  56. New York, New York
  57. New York, New York
  58. New York, New York
  59. Durham, North Carolina
  60. Durham, North Carolina
  61. Durham, North Carolina
  62. Greenville, North Carolina
  63. Greenville, North Carolina
  64. Greenville, North Carolina
  65. Greenville, North Carolina
  66. Cincinnati, Ohio
  67. Cincinnati, Ohio
  68. Cincinnati, Ohio
  69. Cincinnati, Ohio
  70. Cincinnati, Ohio
  71. Columbus, Ohio
  72. Columbus, Ohio
  73. Columbus, Ohio
  74. Columbus, Ohio
  75. Columbus, Ohio
  76. Philadelphia, Pennsylvania
  77. Philadelphia, Pennsylvania
  78. Philadelphia, Pennsylvania
  79. Pittsburgh, Pennsylvania
  80. Pittsburgh, Pennsylvania
  81. Pittsburgh, Pennsylvania
  82. Providence, Rhode Island
  83. Providence, Rhode Island
  84. Providence, Rhode Island
  85. Providence, Rhode Island
  86. Charleston, South Carolina
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  88. Charleston, South Carolina
  89. Charleston, South Carolina
  90. Dallas, Texas
  91. Fort Worth, Texas
  92. Fort Worth, Texas
  93. Grapevine, Texas
  94. Houston, Texas
  95. Houston, Texas
  96. Houston, Texas
  97. Houston, Texas
  98. Houston, Texas
  99. Salt Lake City, Utah
  100. Richmond, Virginia
  101. Richmond, Virginia
  102. Edmonton, Alberta
  103. Edmonton, Alberta
  104. Edmonton, Alberta
  105. Edmonton, Alberta
  106. Edmonton, Alberta
  107. Edmonton, Alberta
  108. Edmonton, Alberta
  109. Edmonton, Alberta
  110. Ottawa, Ontario
  111. Toronto, Ontario
  112. Toronto, Ontario
  113. Montreal, Quebec
  114. Montreal, Quebec
  115. Montreal, Quebec
ALL GENDERS
6 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Safety Of Rivipansel (GMI-1070) In The Treatment Of One or More Vaso-occlusive Crises In Hospitalized Subjects With Sickle Cell Disease
Official Title  ICMJE 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
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).
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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Non-Randomized
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Sickle Cell Anemia
  • Sickle Cell Disease
  • Sickle Cell Disorders
  • Pain Crisis
  • Vaso-occlusive Crisis
Intervention  ICMJE 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
Study Arms  ICMJE
  • Experimental: Cohort 1
    includes one adult stratum (>18 years old) and one pediatric stratum (12-17 years old)
    Intervention: Drug: Rivipansel
  • Experimental: Cohort 2
    includes one pediatric stratum (6-11 years old).
    Intervention: Drug: Rivipansel
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 Terminated
Actual Enrollment  ICMJE
 (submitted: February 18, 2020)		154
Original Estimated Enrollment  ICMJE
 (submitted: April 29, 2015)		250
Actual Study Completion Date  ICMJE November 15, 2019
Actual Primary Completion Date November 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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 NCT02433158
Other Study ID Numbers  ICMJE B5201003
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