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



Status:Completed
Conditions:Anemia
Therapuetic Areas:Hematology
Healthy:No
Age Range:18 - Any
Updated:5/25/2018
Start Date:November 2016
End Date:December 2017

Use our guide to learn which trials are right for you!

A Phase 2 Study of the Safety and Effectiveness of SANGUINATE™ in the Treatment of Vaso-Occlusive Crises in the Ambulatory Setting: A Placebo-Controlled, Single-Dose, Single-Blind Study in Adults With Sickle Cell Disease

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

Patients who are experiencing a vaso-occlusive crisis will report to the clinic for treatment
and screening into the SGSC-005 study. Patients who meet all inclusion/exclusion criteria
will be randomized to receive either SANGUINATE 320 mg/kg or placebo (saline) over a 2 hour
infusion period. Assessments of vital signs, ECGs, safety labs, adverse events as well as
patient and physician questionnaires will be completed up to 6 hours after the start of the
infusion. Patients will then be assessed for discharge either to home or admitted to the
hospital for further treatment depending on their disease severity. Follow-up phone calls
will be completed 24 hours and 7 days after initiation of treatment . A follow-up visit will
be completed in the clinic at 72 hours after initiation of treatment.

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.
We found this trial at
9
sites
655 West Baltimore Street
Baltimore, Maryland 21201
(410) 706-7410
Principal Investigator: Gentry Wilkerson, MD
Phone: 410-328-7635
University of Maryland School of Medicine Established in 1807, The School of Medicine is the...
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Majed Refaai, MD
Phone: 585-275-2141
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
?
mi
from
Rochester, NY
Click here to add this to my saved trials
Baltimore, Maryland
Principal Investigator: Sophie Lanzkron, MD
Phone: 410-502-8642
?
mi
from
Baltimore, MD
Click here to add this to my saved trials
Columbus, Ohio 43210
Principal Investigator: Payal, Desai, MD
Phone: 614-293-5176
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Hollywood, Florida 33021
Principal Investigator: Gershwin Blyden, MD
Phone: 954-397-3251
?
mi
from
Hollywood, FL
Click here to add this to my saved trials
Milwaukee, Wisconsin 53233
Principal Investigator: Joshua Field, MD
Phone: 414-937-6814
?
mi
from
Milwaukee, WI
Click here to add this to my saved trials
201 Lyons Ave
Newark, New Jersey 07112
(973) 926-7000
Principal Investigator: Alice Cohen, MD
Phone: 973-926-7231
Newark Beth Israel Medical Center Newark Beth Israel Medical Center, a regional care, teaching hospital...
?
mi
from
Newark, NJ
Click here to add this to my saved trials
Richmond, Virginia 23298
(804) 828-0100
Principal Investigator: Thokozeni Lipato, MD
Phone: 804-628-1868
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
?
mi
from
Richmond, VA
Click here to add this to my saved trials
1 Tampa General Circle
Tampa, Florida 33606
Principal Investigator: Michael V. Jaglal, MD
Phone: 813-844-8249
?
mi
from
Tampa, FL
Click here to add this to my saved trials