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;