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

NCT01848925 | Completed Phase 1

• 1 other identifier: SGSC-003
• Study Type: interventional
• Target: 24
• Locations: 2 countries
• Sites: 4

Brief Summary

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

Conditions

Sickle Cell Disease

Keywords

SANGUINATE

Outcome Measures

Primary Outcomes (1)

• To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients.

  Compare pain management between SANGUINATE™ and Hydroxyurea using 0-10 Numeric Pain Scale.

  7 days

Study Arms (2)

SANGUINATE™

EXPERIMENTAL

PEG-bHb-CO

Biological: SANGUINATE™

Hydroxyurea

ACTIVE COMPARATOR

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

Drug: Hydroxyurea

Interventions

SANGUINATE™ BIOLOGICAL

40 mg/mL intravenous infusion.

SANGUINATE™

Hydroxyurea DRUG

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

Also known as: Hydroxycarbamide, Brand Names includes: Hydria, Droxia.

Hydroxyurea

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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".

You may not qualify if:

• 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;

Sponsors & Collaborators

• Prolong Pharmaceuticals: lead

Study Sites (4)

Fundacion BIOS

Barranquilla, Colombia

Location

Fundacion Reina Isabel

Cali, Colombia

Location

Hospital Pablo TobinUribe

Medellín, Colombia

Location

PAMRI

Panama City, Panama

Location

MeSH Terms

Conditions

Anemia, Sickle Cell

Interventions

PEGylated carboxyhemoglobin bovine; Hydroxyurea

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Urea; Amides; Organic Chemicals

Study Officials

• Kenny M Galvez, MD

  Hospital Pablo Tobin Uribe

  PRINCIPAL INVESTIGATOR

• Luis F Uribe, MD

  Fundacion Reina Isabel

  PRINCIPAL INVESTIGATOR

• Nestor Sosa, MD

  Hospital Punta Pacifica

  PRINCIPAL INVESTIGATOR

• Angel Hernandez, MD

  Fundacion BIOS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2013
• First Posted: May 8, 2013
• Study Start: May 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: August 1, 2014
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

PA (1); CO (3)