Clinical Trial: A Study of SANGUINATE for the Treatment of Vaso-occlusive Crisis (VOC) in Adult Sickle Cell Disease Patients
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: A Phase II, Multicenter, Single-Blind, Randomized Study of the Safety and Effectiveness of SANGUINATE™ Versus Normal Saline in Adult Sickle Cell Disease Patients Wit
Brief 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 Summary: 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.
Sponsor: Prolong Pharmaceuticals
Current Primary Outcome: Time to readiness for discharge from in hospital stay following treatment with SANGUINATE and Normal Saline. [ Time Frame: Up to 7 Days ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Safety of treatment as defined by changes in vital signs, electrocardiographic, biochemical, hematological, and urinalysis measures, as well as reported increases in pain and other reported adverse events [ Time Frame: Up to 7 Days ]Composite endpoint with multiple vital signs, ECGs, echocardiograms, clinical assessments and bio-analytical lab measurements over the 7 day time frame
- Proportion of patients who develop acute chest syndrome (ACS) during the study. [ Time Frame: Up to 14 Days ]
- Proportion of patients who are re-hospitalized for their vaso-occlusive crisis episode. [ Time Frame: Up to 7 Days ]
- Total length of stay (LOS) following treatment of SANGUINATE versus Normal Saline. [ Time Frame: Up to 7 Days ]
- Percent reduction in total pain medication required during in-hospital stay following treatment with SANGUINATE and Normal Saline. [ Time Frame: Up to 7 Days ]
- Percent reduction in pain score utilizing a visual analog scale following treatment with SANGUINATE and Normal Saline. [ Time Frame: Up to 7 Days ]
- Reduction in the level of C-Reactive Protein following treatment of SANGUINATE versus Normal Saline. [ Time Frame: Up to 7 Days ]
Original Secondary Outcome: Same as current
Information By: Prolong Pharmaceuticals
Dates:
Date Received: February 1, 2016
Date Started: August 2016
Date Completion: September 2017
Last Updated: March 30, 2017
Last Verified: March 2017