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

Primary Purpose

Anemia, Sickle Cell

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SANGUINATE
Placebo
Sponsored by
Prolong Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Anemia, Sickle Cell

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • FSCDR
  • Florida Health Tampa General Hospital
  • University of Maryland School of Medicine
  • Johns Hopkins Univeristy School of Medicine
  • Newark Beth Israel Medical Center
  • University of Rochester Medical Center
  • Ohio State University Medical Center
  • Virginia Commonwealth University
  • Blood Center of Wisconsin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

SANGUINATE

Placebo

Arm Description

320 mg/kg

Normal saline IV infusion

Outcomes

Primary Outcome Measures

Time to readiness for discharge from ambulatory site
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

Secondary Outcome Measures

Safety of treatment
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
Total pain treatment received including the opioid dose (mg/kg) received during ambulatory visit
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)
Reduction in the rate of recurrent ambulatory visit(s) for the VOC within 7 days post discharge
Reduction in the rate of hospitalization(s) for VOC after treatment with SANGUINATE and within 7 days post-discharge

Full Information

First Posted
April 2, 2015
Last Updated
May 22, 2018
Sponsor
Prolong Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT02411708
Brief Title
Study of SANGUINATE™ In the Treatment of Sickle Cell Disease Patients With Vaso-Occlusive Crisis
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
November 2016 (Actual)
Primary Completion Date
December 2017 (Actual)
Study Completion Date
December 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prolong Pharmaceuticals

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Anemia, Sickle Cell

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
SANGUINATE
Arm Type
Experimental
Arm Description
320 mg/kg
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Normal saline IV infusion
Intervention Type
Drug
Intervention Name(s)
SANGUINATE
Other Intervention Name(s)
pegylated carboxyhemoglobin bovine
Intervention Description
Single two-hour infusion of SANGUINATE
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Normal Saline
Intervention Description
Single two-hour infusion of placebo
Primary Outcome Measure Information:
Title
Time to readiness for discharge from ambulatory site
Description
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
Time Frame
7 Days
Secondary Outcome Measure Information:
Title
Safety of treatment
Description
as determined by changes in vital signs, EKG, biochemical, hematological, and urinalysis measures, and reported AEs
Time Frame
1 Day
Title
Extent of reduction in pain score during ambulatory visit as assessed by the participant on a 10-point pain scale
Time Frame
1 Day
Title
Total pain treatment received including the opioid dose (mg/kg) received during ambulatory visit
Time Frame
1 Day
Title
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
Title
Reduction in the rate of recurrent ambulatory visit(s) for the VOC within 7 days post discharge
Time Frame
7 Days
Title
Reduction in the rate of hospitalization(s) for VOC after treatment with SANGUINATE and within 7 days post-discharge
Time Frame
7 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 18 years, Sickle Cell Disease (all genotypes), Diagnosis of a severe vaso-occlusive crisis (VOC), based on the clinical judgement of the Investigator, Participant needs to be admitted to the ambulatory site for treatment of VOC requiring IV pain medication, Able to provide written consent, Able to receive IV infusion of study drug. Exclusion Criteria: In the judgment of the Investigator, the participant is not a good candidate for the study, An acute severe complication of SCD beyond VOC, Pregnant or actively trying to become pregnant, or breastfeeding, Participant had > 6 urgent visits for SCD complications in the prior 3 months, Fewer than 30 days since any prior treatment with IV pain medication for VOC, Onset of current acute painful crisis > 3 days prior to dosing, 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, Concurrent or prior treatment within 90 days with an investigational medication, Abnormal ECG due to cardiac ischemia and/or atrial fibrillation of acute onset, in the opinion of the Investigator.
Facility Information:
Facility Name
FSCDR
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Florida Health Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
University of Maryland School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201-1559
Country
United States
Facility Name
Johns Hopkins Univeristy School of Medicine
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Newark Beth Israel Medical Center
City
Newark
State/Province
New Jersey
ZIP/Postal Code
07112
Country
United States
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14627-0140
Country
United States
Facility Name
Ohio State University Medical Center
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43203
Country
United States
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Facility Name
Blood Center of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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