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

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: NCT02411708
Recruitment Status : Completed
First Posted : April 8, 2015
Last Update Posted : May 23, 2018
Sponsor:
Information provided by (Responsible Party):
Prolong Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE April 2, 2015
First Posted Date  ICMJE April 8, 2015
Last Update Posted Date May 23, 2018
Actual Study Start Date  ICMJE November 2016
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 29, 2016)
Time to readiness for discharge from ambulatory site [ Time Frame: 7 Days ]
Defined as the time from the start of study drug infusion until the time of participant's response that their pain episode has improved enough for discharge; investigator's assessment of participant's readiness for discharge; and participant no longer requires IV opioid administration
Original Primary Outcome Measures  ICMJE
 (submitted: April 7, 2015)
  • Safety of treatment as determined 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: 7 Days ]
  • Time to readiness to discharge: Patient's response that their pain episode has improved enough for discharge from the clinic; Investigator's assessment of patient's readiness for discharge from the clinic; Time to last IV opioid administration. [ Time Frame: 1 Day ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 29, 2016)
  • Safety of treatment [ Time Frame: 1 Day ]
    as determined by changes in vital signs, EKG, biochemical, hematological, and urinalysis measures, and reported AEs
  • Extent of reduction in pain score during ambulatory visit as assessed by the participant on a 10-point pain scale [ Time Frame: 1 Day ]
  • Total pain treatment received including the opioid dose (mg/kg) received during ambulatory visit [ Time Frame: 1 Day ]
  • Global assessment of the participant's improvement by the Investigator or study staff (at the time of readiness for discharge from the ambulatory visit, and at the 72-hour follow-up visit) [ Time Frame: 7 Days ]
  • Reduction in the rate of recurrent ambulatory visit(s) for the VOC within 7 days post discharge [ Time Frame: 7 Days ]
  • Reduction in the rate of hospitalization(s) for VOC after treatment with SANGUINATE and within 7 days post-discharge [ Time Frame: 7 Days ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 7, 2015)
  • Number of patients on treatment with pain score at discharge ≤ 5 on a 10-point scale [ Time Frame: 1 Day ]
  • Total pain treatment received during clinic stay [ Time Frame: 1 Day ]
  • Total opioid dose (mg/kg) administered during clinic stay [ Time Frame: 1 Day ]
  • Patient overall improvement using the 10-point scale Numeric Pain Rating Scale [ Time Frame: 1 Day ]
  • Global assessment of the patient's improvement by the investigator (at the time of clinic discharge, at the 72-hour follow-up visit, and during the Day 7 telephone contact) using the Physician Global Assessment - Improvement Scale (PGA-I). [ Time Frame: 7 Days ]
  • Reduction in the repeat clinic visit rate for VOC (clinic discharge to 7 days post-discharge) [ Time Frame: 7 Days ]
  • Reduction in the hospitalization rate for VOC (clinic discharge to 7 days post-discharge) [ Time Frame: 7 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of SANGUINATE™ In the Treatment of Sickle Cell Disease Patients With Vaso-Occlusive Crisis
Official Title  ICMJE 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
Brief Summary Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis
Detailed Description 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.
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
    Single two-hour infusion of SANGUINATE
    Other Name: pegylated carboxyhemoglobin bovine
  • Drug: Placebo
    Single two-hour infusion of placebo
    Other Name: Normal Saline
Study Arms  ICMJE
  • Experimental: SANGUINATE
    320 mg/kg
    Intervention: Drug: SANGUINATE
  • Placebo Comparator: Placebo
    Normal saline IV infusion
    Intervention: Drug: Placebo
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: April 7, 2015)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 2017
Actual Primary Completion Date December 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02411708
Other Study ID Numbers  ICMJE SGSC-005
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Prolong Pharmaceuticals
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Prolong Pharmaceuticals
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
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