Summary

for people ages 6 years and up (full criteria)
at Oakland, California and other locations
study started
estimated completion

Description

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.

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 HOSPITALIZED SUBJECTS WITH SICKLE CELL DISEASE

Keywords

Anemia, Sickle CellSickle Cell AnemiaSickle Cell DiseaseSickle Cell Disorderspain crisisvaso-occlusive crisisrivipanselGMI-1070selectin inhibitorSCDVOC

Eligibility

You can join if…

Open to people ages 6 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • UCSF Benioff Children's Hospital Oakland accepting new patients
    OaklandCalifornia94609United States
  • UC Davis Medical Center Main Hospital accepting new patients
    SacramentoCalifornia95817United States
  • UC Davis Medical Center accepting new patients
    SacramentoCalifornia95817United States
  • University of California Davis Medical Center accepting new patients
    SacramentoCalifornia95817United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Pfizer
Links
To obtain contact information for a study center near you, click here.
ID
NCT02187003
Phase
Phase 3
Study Type
Interventional
Last Updated