Trial | NCT01848925  Report issue

Title

Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients
A Phase I Open-label, Randomized, Safety and Efficacy Study of SANGUINATE™ at Two Doses Levels Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients.

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    24
The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.
Study Started
May 31
2013
Primary Completion
Jul 31
2014
Study Completion
Aug 31
2014
Last Update
Dec 03
2014
Estimate

Biological SANGUINATE™

40 mg/mL intravenous infusion.

Drug Hydroxyurea

Standard of care for Sickle Cell treatment, 15 mg/kg.

  • Other names: Hydroxycarbamide, Brand Names includes: Hydria, Droxia.

SANGUINATE™ Experimental

PEG-bHb-CO

Hydroxyurea Active Comparator

Standard of care for Sickle Cell treatment, 15 mg/kg.

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;
No Results Posted