Status:
COMPLETED
Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients
Lead Sponsor:
Prolong Pharmaceuticals
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
19+ years
Phase:
PHASE1
Brief Summary
The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.
Eligibility Criteria
Inclusion
- Patients with Homozygous (HbSS) Sickle Cell Anemia;
- Hb levels: \>6g/dL - \<10g/dL;
- Age : \>18 years old;
- Frequency of ER hospitalizations \< 6x/yr for SCD pain events documented "medical history".
Exclusion
- Patients, who are on chronic transfusion program, defined as regular transfusions every 2-8 weeks;
- 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;
Key Trial Info
Start Date :
May 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2014
Estimated Enrollment :
24 Patients enrolled
Trial Details
Trial ID
NCT01848925
Start Date
May 1 2013
End Date
August 1 2014
Last Update
December 3 2014
Active Locations (4)
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1
Fundacion BIOS
Barranquilla, Colombia
2
Fundacion Reina Isabel
Cali, Colombia
3
Hospital Pablo TobinUribe
Medellín, Colombia
4
PAMRI
Panama City, Panama