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

December 2, 2014 updated by: Prolong Pharmaceuticals

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Barranquilla, Colombia
        • Fundacion BIOS
      • Cali, Colombia
        • Fundación Reina Isabel
      • Medellin, Colombia
        • Hospital Pablo TobinUribe
  • Panama
      • Panama City, Panama
        • PAMRI

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SANGUINATE™
PEG-bHb-CO
Biological: SANGUINATE™
40 mg/mL intravenous infusion.
Active Comparator: Hydroxyurea
Standard of care for Sickle Cell treatment, 15 mg/kg.
Drug: Hydroxyurea
Standard of care for Sickle Cell treatment, 15 mg/kg.
Other Names:
  • Hydroxycarbamide
  • Brand Names includes: Hydria, Droxia.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Prolong Pharmaceuticals

Investigators

  • Principal Investigator: Kenny M Galvez, MD, Hospital Pablo Tobin Uribe
  • Principal Investigator: Luis F Uribe, MD, Fundación Reina Isabel
  • Principal Investigator: Nestor Sosa, MD, Hospital Punta Pacifica
  • Principal Investigator: Angel Hernandez, MD, Fundacion BIOS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2013

Primary Completion (Actual)

July 1, 2014

Study Completion (Actual)

August 1, 2014

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

May 3, 2013

First Posted (Estimate)

May 8, 2013

Study Record Updates

Last Update Posted (Estimate)

December 3, 2014

Last Update Submitted That Met QC Criteria

December 2, 2014

Last Verified

December 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SGSC-003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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