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

Status: Recruiting
Phase: Phase 3
DFCI Protocol ID:

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.

Conducting Institutions:

Dana-Farber Cancer Institute, Children's Hospital Boston, Brigham and Women's Hospital

Overall PI:

Matthew Heeney, MD, Children's Hospital Boston

Site-responsible Investigators:

Contacts:

Dana-Farber Cancer Institute: Childrens Hospital Pediatric Clinical Translation Investigation Program CTIP, ctip@partners.org

Eligibility Criteria

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

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