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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01848925
Recruitment Status : Completed
First Posted : May 8, 2013
Last Update Posted : December 3, 2014
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Sickle Cell Disease Biological: SANGUINATE™ Drug: Hydroxyurea Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Open-label, Randomized, Safety and Efficacy Study of SANGUINATE™ at Two Doses Levels Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients.
Study Start Date : May 2013
Actual Primary Completion Date : July 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Hydroxyurea

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.




Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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;

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01848925


Locations
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Colombia
Fundacion BIOS
Barranquilla, Colombia
Fundacion Reina Isabel
Cali, Colombia
Hospital Pablo TobinUribe
Medellin, Colombia
Panama
PAMRI
Panama City, Panama
Sponsors and Collaborators
Prolong Pharmaceuticals
Investigators
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Principal Investigator: 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

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Responsible Party: Prolong Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01848925     History of Changes
Other Study ID Numbers: SGSC-003
First Posted: May 8, 2013    Key Record Dates
Last Update Posted: December 3, 2014
Last Verified: December 2014

Keywords provided by Prolong Pharmaceuticals:
SANGUINATE

Additional relevant MeSH terms:
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Anemia, Sickle Cell
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Hydroxyurea
Antineoplastic Agents
Antisickling Agents
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors