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

Biossil Inc.

Status and phase: Completed; Phase 3

Conditions: Anemia, Sickle Cell

Treatments: Other: Placebo; Drug: Rivipansel

Study type: Interventional

Funder types: Industry

Identifiers

NCT02187003

RESET

B5201002

Details and patient eligibility

About

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.

Enrollment: 345 patients

Sex: All

Ages: 6+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

345 participants in 2 patient groups, including a placebo group

Rivipansel Treatment Arm

Experimental group

Treatment:

Drug: Rivipansel

Placebo Treatment Arm

Placebo Comparator group

Treatment:

Other: Placebo