NCT02672540

A Study of SANGUINATE for the Treatment of Vaso-occlusive Crisis (VOC) in Adult Sickle Cell Disease Patients

A Phase II, Multicenter, Single-Blind, Randomized Study of the Safety and Effectiveness of SANGUINATE™ Versus Normal Saline in Adult Sickle Cell Disease Patients With Vaso-Occlusive Crisis (VOC)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Prolong Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis who are admitted to the hospital for treatment.

Detailed description

A single-blind, multicenter, randomized, placebo-control study in which 30 Sickle Cell disease patients having a vaso-occlusive crisis will either receive SANGUINATE 320 mg/kg/patient (8 mL/kg/patient) or Normal Saline on Day 1 (Visit 1) and Day 2 (Visit 2) infused over 2 hours each day. Patients are to remain in the hospital for up to 7 days but can be discharged at any time after receiving the second dose of SANGUINATE, provided their vaso-occlusive crisis has resolved and the patient has completed discharge procedures. Patients will have a follow-up phone call 7 days after discharge from the hospital to obtain safety, concomitant medication and pain assessments.

Conditions

• Anemia, Sickle Cell

Interventions

Type	Name	Description
DRUG	SANGUINATE 320 mg/kg	Two-hour infusion of SANGUINATE on Day 1 and Day 2
DRUG	Normal Saline	Two-hour infusion of Normal Saline and Day 1 and Day 2

Timeline

• Start date: 2016-07-01
• Primary completion: 2017-05-31
• Completion: 2017-05-31
• First posted: 2016-02-03
• Last updated: 2018-05-23

Locations

4 sites across 4 countries: Colombia, Dominican Republic, Honduras, Panama