Study of SANGUINATE™ In the Treatment of Sickle Cell Disease Patients With Vaso-Occlusive Crisis
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| ClinicalTrials.gov Identifier: NCT02411708 |
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Recruitment Status :
Completed
First Posted : April 8, 2015
Last Update Posted : May 23, 2018
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Sponsor:
Prolong Pharmaceuticals
Information provided by (Responsible Party):
Prolong Pharmaceuticals
- Study Details
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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 |
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 : | 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 |
| Actual Study Start Date : | November 2016 |
| Actual Primary Completion Date : | December 2017 |
| Actual Study Completion Date : | December 2017 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Sickle cell disease
| Arm | Intervention/treatment |
|---|---|
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Experimental: SANGUINATE
320 mg/kg
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Drug: SANGUINATE
Single two-hour infusion of SANGUINATE
Other Name: pegylated carboxyhemoglobin bovine |
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Placebo Comparator: Placebo
Normal saline IV infusion
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Drug: Placebo
Single two-hour infusion of placebo
Other Name: Normal Saline |
Primary Outcome Measures :
- 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 :
- 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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| Responsible Party: | Prolong Pharmaceuticals |
| ClinicalTrials.gov Identifier: | NCT02411708 |
| Other Study ID Numbers: |
SGSC-005 |
| First Posted: | April 8, 2015 Key Record Dates |
| Last Update Posted: | May 23, 2018 |
| Last Verified: | May 2018 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
Additional relevant MeSH terms:
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Anemia, Sickle Cell Anemia, Hemolytic, Congenital Anemia, Hemolytic Anemia |
Hematologic Diseases Hemoglobinopathies Genetic Diseases, Inborn |