Back to resultsStudy of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients
Primary Purpose
Sickle Cell Disease
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
SANGUINATE™
Hydroxyurea
Sponsored by
About this trial
This is an interventional treatment trial for Sickle Cell Disease focused on measuring SANGUINATE
Eligibility 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;
Sites / Locations
- Fundacion BIOS
- Fundacion Reina Isabel
- Hospital Pablo TobinUribe
- PAMRI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SANGUINATE™
Hydroxyurea
Arm Description
PEG-bHb-CO
Standard of care for Sickle Cell treatment, 15 mg/kg.
Outcomes
Primary Outcome Measures
To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients.
Compare pain management between SANGUINATE™ and Hydroxyurea using 0-10 Numeric Pain Scale.
Secondary Outcome Measures
Full Information
NCT ID
NCT01848925
First Posted
April 23, 2013
Last Updated
December 2, 2014
Sponsor
Prolong Pharmaceuticals
1. Study Identification
Unique Protocol Identification Number
NCT01848925
Brief Title
Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients
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 Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
May 2013 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Prolong Pharmaceuticals
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Disease
Keywords
SANGUINATE
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SANGUINATE™
Arm Type
Experimental
Arm Description
PEG-bHb-CO
Arm Title
Hydroxyurea
Arm Type
Active Comparator
Arm Description
Standard of care for Sickle Cell treatment, 15 mg/kg.
Intervention Type
Biological
Intervention Name(s)
SANGUINATE™
Intervention Description
40 mg/mL intravenous infusion.
Intervention Type
Drug
Intervention Name(s)
Hydroxyurea
Other Intervention Name(s)
Hydroxycarbamide, Brand Names includes: Hydria, Droxia.
Intervention Description
Standard of care for Sickle Cell treatment, 15 mg/kg.
Primary Outcome Measure Information:
Title
To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients.
Description
Compare pain management between SANGUINATE™ and Hydroxyurea using 0-10 Numeric Pain Scale.
Time Frame
7 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kenny M Galvez, MD
Organizational Affiliation
Hospital Pablo Tobin Uribe
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Luis F Uribe, MD
Organizational Affiliation
Fundacion Reina Isabel
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Nestor Sosa, MD
Organizational Affiliation
Hospital Punta Pacifica
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angel Hernandez, MD
Organizational Affiliation
Fundacion BIOS
Official's Role
Principal Investigator
Facility Information:
Facility Name
Fundacion BIOS
City
Barranquilla
Country
Colombia
Facility Name
Fundacion Reina Isabel
City
Cali
Country
Colombia
Facility Name
Hospital Pablo TobinUribe
City
Medellin
Country
Colombia
Facility Name
PAMRI
City
Panama City
Country
Panama
12. IPD Sharing Statement
Learn more about this trial
Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients
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