Overview
Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients
Status:
Completed
Completed
Trial end date:
2014-08-01
2014-08-01
Target enrollment:
0
0
Participant gender:
All
All
Summary
The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.Phase:
Phase 1Accepts Healthy Volunteers?
NoDetails
Lead Sponsor:
Prolong PharmaceuticalsTreatments:
Hydroxyurea
Criteria
Inclusion Criteria:- 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 Criteria:
- 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;