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

Prolong Pharmaceuticals

Status and phase

Completed

Phase 1

Conditions

Sickle Cell Disease

Treatments

Biological: SANGUINATE™

Drug: Hydroxyurea

Study type

Interventional

Funder types

Industry

Identifiers

SGSC-003

Details and patient eligibility

About

The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.

Enrollment

24 patients

Sex

All

Ages

19+ years old

Volunteers

No Healthy Volunteers

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;