Study of SANGUINATE™ In the Treatment of Sickle Cell Disease Patients With Vaso-Occlusive Crisis
Completed · Phase 2 · Has a placebo group
Conditions studied: Anemia, Sickle Cell
In brief
Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis
Key facts
- Study ID
- NCT02411708
- Run by
- Prolong Pharmaceuticals
- People needed
- 24
- Starts
- 2016-11-01
- Expected to finish
- 2017-12-01
- Last updated by the study team
- 2018-05-23
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age ≥ 18 years,
- Sickle Cell Disease (all genotypes),
- Diagnosis of a severe vaso-occlusive crisis (VOC), based on the clinical judgement of the Investigator,
- Participant needs to be admitted to the ambulatory site for treatment of VOC requiring IV pain medication,
- Able to provide written consent,
- Able to receive IV infusion of study drug.
You may not qualify if…
- In the judgment of the Investigator, the participant is not a good candidate for the study,
- An acute severe complication of SCD beyond VOC,
- Pregnant or actively trying to become pregnant, or breastfeeding,
- Participant had > 6 urgent visits for SCD complications in the prior 3 months,
- Fewer than 30 days since any prior treatment with IV pain medication for VOC,
- Onset of current acute painful crisis > 3 days prior to dosing,
- 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,
- Concurrent or prior treatment within 90 days with an investigational medication,
- Abnormal ECG due to cardiac ischemia and/or atrial fibrillation of acute onset, in the opinion of the Investigator.
Where it is running
- FSCDR — Hollywood, Florida, United States
- Florida Health Tampa General Hospital — Tampa, Florida, United States
- University of Maryland School of Medicine — Baltimore, Maryland, United States
- Johns Hopkins Univeristy School of Medicine — Baltimore, Maryland, United States
- Newark Beth Israel Medical Center — Newark, New Jersey, United States
- University of Rochester Medical Center — Rochester, New York, United States
- Ohio State University Medical Center — Columbus, Ohio, United States
- Virginia Commonwealth University — Richmond, Virginia, United States
- Blood Center of Wisconsin — Milwaukee, Wisconsin, United States
Full record on ClinicalTrials.gov
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