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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

Official Title: 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 Hos

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 Summary:
Sponsor: Pfizer

Current Primary Outcome: 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: 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.


Current Secondary Outcome:

  • 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: Same as current

Information By: Pfizer

Dates:
Date Received: June 12, 2014
Date Started: June 8, 2015
Date Completion: July 10, 2018
Last Updated: May 17, 2017
Last Verified: May 2017