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

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ClinicalTrials.gov Identifier: NCT02672540
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Prolong Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 1, 2016
First Posted Date  ICMJE February 3, 2016
Last Update Posted Date May 23, 2018
Actual Study Start Date  ICMJE July 2016
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2016)
  • 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 Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of SANGUINATE for the Treatment of Vaso-occlusive Crisis (VOC) in Adult Sickle Cell Disease Patients
Official Title  ICMJE 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)
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 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Anemia, Sickle Cell
Intervention  ICMJE
  • Drug: SANGUINATE 320 mg/kg
    Two-hour infusion of SANGUINATE on Day 1 and Day 2
    Other Name: pegylated carboxyhemoglobin bovine
  • Drug: Normal Saline
    Two-hour infusion of Normal Saline and Day 1 and Day 2
Study Arms  ICMJE
  • Experimental: SANGUINATE 320 mg/kg
    Two-hour infusion of SANGUINATE on Day 1 and Day 2
    Intervention: Drug: SANGUINATE 320 mg/kg
  • Placebo Comparator: Normal Saline
    Two-hour infusion of Normal Saline and Day 1 and Day 2
    Intervention: Drug: Normal Saline
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 22, 2018)
34
Original Estimated Enrollment  ICMJE
 (submitted: February 1, 2016)
30
Actual Study Completion Date  ICMJE May 31, 2017
Actual Primary Completion Date May 31, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia,   Dominican Republic,   Honduras,   Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02672540
Other Study ID Numbers  ICMJE SGSC-002
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Prolong Pharmaceuticals
Study Sponsor  ICMJE Prolong Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Hemant Misra, PhD Prolong Pharmaceuticals
PRS Account Prolong Pharmaceuticals
Verification Date May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP