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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02672540
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : May 23, 2018
Information provided by (Responsible Party):
Prolong Pharmaceuticals

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.

Condition or disease Intervention/treatment Phase
Anemia, Sickle Cell Drug: SANGUINATE 320 mg/kg Drug: Normal Saline Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 With Vaso-Occlusive Crisis (VOC)
Actual Study Start Date : July 2016
Actual Primary Completion Date : May 31, 2017
Actual Study Completion Date : May 31, 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: SANGUINATE 320 mg/kg
Two-hour infusion of SANGUINATE on Day 1 and Day 2
Drug: SANGUINATE 320 mg/kg
Two-hour infusion of SANGUINATE on Day 1 and Day 2
Other Name: pegylated carboxyhemoglobin bovine

Placebo Comparator: Normal Saline
Two-hour infusion of Normal Saline and Day 1 and Day 2
Drug: Normal Saline
Two-hour infusion of Normal Saline and Day 1 and Day 2

Primary Outcome Measures :
  1. Time to readiness for discharge from in hospital stay following treatment with SANGUINATE and Normal Saline. [ Time Frame: Up to 7 Days ]
    Defined as the patient's response that their pain episode has improved enough for discharge from the hospital, or the Investigator's assessment that the patient is ready for discharge from the hospital.

Secondary Outcome Measures :
  1. 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

  2. Proportion of patients who develop acute chest syndrome (ACS) during the study. [ Time Frame: Up to 14 Days ]
  3. Proportion of patients who are re-hospitalized for their vaso-occlusive crisis episode. [ Time Frame: Up to 7 Days ]
  4. Total length of stay (LOS) following treatment of SANGUINATE versus Normal Saline. [ Time Frame: Up to 7 Days ]
  5. Percent reduction in total pain medication required during in-hospital stay following treatment with SANGUINATE and Normal Saline. [ Time Frame: Up to 7 Days ]
  6. Percent reduction in pain score utilizing a visual analog scale following treatment with SANGUINATE and Normal Saline. [ Time Frame: Up to 7 Days ]
  7. Reduction in the level of C-Reactive Protein following treatment of SANGUINATE versus Normal Saline. [ Time Frame: Up to 7 Days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Age ≥ 18 and ≤ 65 years of age
  2. Diagnosis of Sickle Cell Disease (Hb-SS or any Genotype)
  3. Pain-score due to vaso-occlusive pain crisis (VOC) ≥ 8 on a 10 point scale
  4. VOC pain location ≥ 1 sites typical of vaso-occlusive crisis
  5. Patients with Priapism, acute chest syndrome, and/or with other Sickle Cell Disease comorbidities can be enrolled with good judgment of the Investigator.
  6. Signed and dated informed written consent by the subject
  7. Able to receive intravenous infusion of SANGUINATE or Normal Saline
  8. Women of childbearing potential with a negative serum pregnancy test and using a reliable method of contraception during the study period and for 30 days thereafter. Male study participants also agree to use contraception for 30 days after the study period

Exclusion Criteria:

  1. In the judgment of the investigator, the patient is not a good candidate for the study
  2. Females who are lactating and/or breastfeeding
  3. Fewer than 14 days since prior infusion pain medication treatment for VOC
  4. Medical history or evidence of moderate to severe renal insufficiency (estimated GFR < 60 mL/min) or chronic kidney disease, or of moderate to severe hepatic disease (ALTs > 5 x ULN)
  5. Concurrent or prior treatment within 30 days of Screening with an investigational medication.
  6. Symptoms or electrocardiogram (ECG)-based signs of acute myocardial infarction, unstable angina pectoris, decompensated heart failure, third degree heart block or cardiac arrhythmia associated with hemodynamic instability;
  7. Severe or unstable concomitant condition or disease (e.g., known significant neurologic deficit, cancer, hematologic, metabolic or coronary disease), or chronic condition (e.g., psychiatric disorder), that, in the opinion of the Investigator, may increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results;
  8. Evidence or history of regular alcohol abuse
  9. Screening laboratory result indicating serologic positivity for hepatitis C antibodies or hepatitis B surface antigens, unless explained by a documented vaccination.
  10. Unable to comply with study attendance, protocol procedures or other study requirements;
  11. Abnormal Echocardiogram at Study Entry (defined as Tricuspid Regurgitant Jet Velocity >3.1 m/sec).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02672540

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Bogota, Colombia
Dominican Republic
Santo Domingo, Dominican Republic
San Pedro Sula, Honduras
Panama City, Panama
Sponsors and Collaborators
Prolong Pharmaceuticals
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Study Director: Hemant Misra, PhD Prolong Pharmaceuticals
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Responsible Party: Prolong Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02672540    
Other Study ID Numbers: SGSC-002
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: May 23, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Prolong Pharmaceuticals:
Sickle Cell
Vaso occlusive crisis
Additional relevant MeSH terms:
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Anemia, Sickle Cell
Hematologic Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Genetic Diseases, Inborn