Study of SANGUINATE™ In the Treatment of Sickle Cell Disease Patients With Vaso-Occlusive Crisis

• Status: Completed
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Prolong Pharmaceuticals

Criteria

Inclusion Criteria:

1. Age ≥ 18 years,

2. Sickle Cell Disease (all genotypes),

3. Diagnosis of a severe vaso-occlusive crisis (VOC), based on the clinical judgement of the Investigator,

4. Participant needs to be admitted to the ambulatory site for treatment of VOC requiring IV pain medication,

5. Able to provide written consent,

6. Able to receive IV infusion of study drug.

Exclusion Criteria:

1. In the judgment of the Investigator, the participant is not a good candidate for the study,

2. An acute severe complication of SCD beyond VOC,

3. Pregnant or actively trying to become pregnant, or breastfeeding,

4. Participant had > 6 urgent visits for SCD complications in the prior 3 months,

5. Fewer than 30 days since any prior treatment with IV pain medication for VOC,

6. Onset of current acute painful crisis > 3 days prior to dosing,

7. Evidence of moderate to severe renal insufficiency (CrCl < 50 mL/min) or chronic kidney disease, or of moderate to severe hepatic disease (LFTs > 2 x ULN) based on past medical history,

8. Concurrent or prior treatment within 90 days with an investigational medication,

9. Abnormal ECG due to cardiac ischemia and/or atrial fibrillation of acute onset, in the opinion of the Investigator.