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Trial record 2 of 2 for:    b5201002

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02187003
Recruitment Status : Completed
First Posted : July 10, 2014
Last Update Posted : June 22, 2020
Sponsor:
Information provided by (Responsible Party):
GlycoMimetics Incorporated

Tracking Information
First Submitted Date  ICMJE June 12, 2014
First Posted Date  ICMJE July 10, 2014
Last Update Posted Date June 22, 2020
Actual Study Start Date  ICMJE June 17, 2015
Actual Primary Completion Date May 3, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
Time to readiness-for-discharge. [ Time Frame: Assessments will be every 4 hours (from 6am to 10pm, daily) for the duration of hospitalization, an expected average of 5 days ]
Time to readiness-for-discharge, defined as the difference between the readiness-for-discharge date and time and the start date and time of the first infusion of study drug.
Original Primary Outcome Measures  ICMJE
 (submitted: July 7, 2014)
Time to readiness-for-discharge. [ Time Frame: Assessments will be every 4 hours for the duration of hospitalization, an expected average of 5 days ]
Time to readiness-for-discharge, defined as the difference between the readiness-for-discharge date and time and the start date and time of the first infusion of study drug.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 7, 2014)
  • Time to discharge. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    Time to discharge, is the difference between the time and date of hospital discharge order and the time and date of start of the first infusion of study drug.
  • Cumulative IV opioid consumption from the time of the loading dose of study drug to discharge. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    Cumulative IV opioid consumption from the time of the loading dose of study drug to discharge.
  • Time to discontinuation of IV opioids. [ Time Frame: Participants will be followed for the duration of hospital stay, an expected average of 5 days ]
    Time to discontinuation of IV opioids.
  • Cumulative IV opioid consumption within the first 24 hours post-loading dose of study drug. [ Time Frame: Day 1 ]
    Cumulative IV opioid consumption within the first 24 hours post-loading dose of study drug.
  • Percent of subjects re-hospitalized for VOC within 3 days of discharge. [ Time Frame: Within 3 days of discharge ]
    Percent of subjects re-hospitalized for VOC within 3 days of discharge.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Center Pfizer
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