Overview

Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients

Status:
Completed
Trial end date:
2014-08-01
Target enrollment:
0
Participant gender:
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 1
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Prolong Pharmaceuticals
Treatments:
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;