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

a study on Anemia Sickle Cell Anemia

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 Cell Sickle Cell Anemia Sickle Cell Disease Sickle Cell Disorders pain crisis vaso-occlusive crisis rivipansel GMI-1070 selectin inhibitor SCD VOC

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
    Oakland California 94609 United States
  • UC Davis Medical Center Main Hospital accepting new patients
    Sacramento California 95817 United States
  • UC Davis Medical Center accepting new patients
    Sacramento California 95817 United States
  • University of California Davis Medical Center accepting new patients
    Sacramento California 95817 United 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
July 31, 2018