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Treatment of Vaso-occlusive Crisis

Treatment of Vaso-occlusive Crisis
The Study: 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
Status
This study is currently recruiting participants.

Formal Name
GMI-1070 in SCD: reduction in time to resolution of vaso-occlusive events and decreased opioid use
Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Purpose
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.

Eligibility
Ages Eligible for Study: 6 Years and older (Child, Adult, Senior)
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No

Criteria
1.Inclusion Criteria:
I.At least 6 years of age.
II.Documented diagnosis of sickle cell disease.
III.Diagnosis of vaso-occlusive crisis necessitating admission to the hospital with treatment including IV opioids.
IV.Able to receive the first dose of study drug within 24 hours from the administration of IV opioids.
2.Exclusion Criteria:
I.Serious systemic infection
II.Acute Chest Syndrome
III.Serious concomitant medical problems (for example, stroke)
IV.SCD pain atypical of VOC
V.Severe renal or hepatic impairment
VI.Chronic pain rather than a presentation of acute VOC

Locations

Ontario
1.Children's Hospital Of Eastern Ontario -------- Recruiting
Ottawa, Ontario, Canada, K1H 8L1
Coordinator: Isabelle Laforest
Email: ilaforest@cheo.on.ca
PH: (613) 737-7600 ext. 3558
2.The Hospital for Sick Children ------------- Recruiting
Toronto, Ontario, Canada, M5G1X8
3.Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Coordinator: Rebecca Leroux
Email: rbcd.clinicaltrials@uhn.ca

Sources
ClinicalTrials.gov A service of the U.S. National Institutes of Health
ClinicalTrials.gov Identifier: NCT02187003
This study is currently recruiting participants.
Verified September 30th, 2017
For more detailed information on this study and others and for the most recent updates, please go to clinicaltrials.gov. ClinicalTrials.gov is a registry and results database of publicly and privately supported clinical studies of human participants conducted around the world.