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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01848925

Enrollment

Registered

2013-05-08

Start date

2013-05-31

Completion date

2014-08-31

Last updated

2014-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sickle Cell Disease

Keywords

SANGUINATE

Brief summary

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

Interventions

BIOLOGICALSANGUINATE™

40 mg/mL intravenous infusion.

DRUGHydroxyurea

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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;

Design outcomes

Primary

Measure	Time frame	Description
To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients.	7 days	Compare pain management between SANGUINATE™ and Hydroxyurea using 0-10 Numeric Pain Scale.

Countries

Colombia, Panama

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026