Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients
NCT ID: NCT01848925
Last Updated: 2014-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
24 participants
INTERVENTIONAL
2013-05-31
2014-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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SANGUINATE™
PEG-bHb-CO
SANGUINATE™
40 mg/mL intravenous infusion.
Hydroxyurea
Standard of care for Sickle Cell treatment, 15 mg/kg.
Hydroxyurea
Standard of care for Sickle Cell treatment, 15 mg/kg.
Interventions
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SANGUINATE™
40 mg/mL intravenous infusion.
Hydroxyurea
Standard of care for Sickle Cell treatment, 15 mg/kg.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Hb levels: \>6g/dL - \<10g/dL;
* Age : \>18 years old;
* Frequency of ER hospitalizations \< 6x/yr for SCD pain events documented "medical history".
Exclusion Criteria
* Allergic to Hydroxyurea;
* History of clinical significant disease, as determined by the Investigator;
* History of allergy or major allergic reaction considered to be clinically significant by the Investigator;
* Screening assessments considered to be abnormal by the Investigator;
* Patient has sever pulmonary hypertension (index \>3 meters per sec);
* Donated blood within 60 days of screening or otherwise experienced blood loss of \>250 mL within the same period;
* Intending to begin new concomitant drug therapy or over-the-counter medication anytime from scree4nin to the time of administration of study drug;
19 Years
ALL
No
Sponsors
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Prolong Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Kenny M Galvez, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Pablo Tobin Uribe
Luis F Uribe, MD
Role: PRINCIPAL_INVESTIGATOR
Fundacion Reina Isabel
Nestor Sosa, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Punta Pacifica
Angel Hernandez, MD
Role: PRINCIPAL_INVESTIGATOR
Fundacion BIOS
Locations
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Fundacion BIOS
Barranquilla, , Colombia
Fundacion Reina Isabel
Cali, , Colombia
Hospital Pablo TobinUribe
Medellín, , Colombia
PAMRI
Panama City, , Panama
Countries
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Other Identifiers
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SGSC-003
Identifier Type: -
Identifier Source: org_study_id