We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : Active, not recruiting
First Posted : April 8, 2015
Last Update Posted : December 13, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
Safety and effect of SANGUINATE on Sickle Cell Disease patients experiencing a vaso-occlusive crisis

Condition or disease Intervention/treatment Phase
Anemia, Sickle Cell Drug: SANGUINATE Drug: Placebo Phase 2

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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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 Start Date : November 2016
Primary Completion Date : December 2017
Estimated Study Completion Date : March 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: SANGUINATE
320 mg/kg
Drug: SANGUINATE
Single two-hour infusion of SANGUINATE
Other Name: pegylated carboxyhemoglobin bovine
Placebo Comparator: Placebo
Normal saline IV infusion
Drug: Placebo
Single two-hour infusion of placebo
Other Name: Normal Saline


Outcome Measures

Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Safety of treatment [ Time Frame: 1 Day ]
    as determined by changes in vital signs, EKG, biochemical, hematological, and urinalysis measures, and reported AEs

  2. Extent of reduction in pain score during ambulatory visit as assessed by the participant on a 10-point pain scale [ Time Frame: 1 Day ]
  3. Total pain treatment received including the opioid dose (mg/kg) received during ambulatory visit [ Time Frame: 1 Day ]
  4. 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 ]
  5. Reduction in the rate of recurrent ambulatory visit(s) for the VOC within 7 days post discharge [ Time Frame: 7 Days ]
  6. Reduction in the rate of hospitalization(s) for VOC after treatment with SANGUINATE and within 7 days post-discharge [ Time Frame: 7 Days ]

Eligibility Criteria

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations

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): NCT02411708


Locations
United States, Florida
FSCDR
Hollywood, Florida, United States, 33021
Florida Health Tampa General Hospital
Tampa, Florida, United States, 33606
United States, Maryland
University of Maryland School of Medicine
Baltimore, Maryland, United States, 21201-1559
Johns Hopkins Univeristy School of Medicine
Baltimore, Maryland, United States, 21205
United States, New Jersey
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14627-0140
United States, Ohio
Ohio State University Medical Center
Columbus, Ohio, United States, 43203
United States, Virginia
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
United States, Wisconsin
Blood Center of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Prolong Pharmaceuticals
More Information

Responsible Party: Prolong Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02411708     History of Changes
Other Study ID Numbers: SGSC-005
First Posted: April 8, 2015    Key Record Dates
Last Update Posted: December 13, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn