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

Phase 1

Completed

• Conditions: Sickle Cell Disease
• Interventions: Biological: SANGUINATE™; Drug: Hydroxyurea

• Registration Number: NCT01848925
• Lead Sponsor: Prolong Pharmaceuticals

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-04-23
• Study Start: 2013-05
• Study First Submitted QC: 2013-05-03
• Study First Posted: 2013-05-08
• Primary Completion: 2014-07
• Study Completion: 2014-08
• Status Verified: 2014-12
• Last Update Submitted: 2014-12-02
• Last Update Posted: 2014-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SANGUINATE™	SANGUINATE™	PEG-bHb-CO
Hydroxyurea	Hydroxyurea	Standard of care for Sickle Cell treatment, 15 mg/kg.

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (4)

Fundacion BIOS; 🇨🇴 Barranquilla, Colombia

Hospital Pablo TobinUribe; 🇨🇴 Medellin, Colombia

PAMRI; 🇵🇦 Panama City, Panama

Fundacion Reina Isabel; 🇨🇴 Cali, Colombia