- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01848925
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.
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
|
40 mg/mL intravenous infusion.
|
Active Comparator: Hydroxyurea
Standard of care for Sickle Cell treatment, 15 mg/kg.
|
Standard of care for Sickle Cell treatment, 15 mg/kg.
Other Names:
|
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
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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