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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

Tracking Information
First Submitted Date  ICMJE April 23, 2013
First Posted Date  ICMJE May 8, 2013
Last Update Posted Date December 3, 2014
Study Start Date  ICMJE May 2013
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 3, 2013)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01848925 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients
Official Title  ICMJE A Phase I Open-label, Randomized, Safety and Efficacy Study of SANGUINATE™ at Two Doses Levels Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients.
Brief Summary The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • Biological: SANGUINATE™
    40 mg/mL intravenous infusion.
  • Drug: Hydroxyurea
    Standard of care for Sickle Cell treatment, 15 mg/kg.
    Other Names:
    • Hydroxycarbamide
    • Brand Names includes: Hydria, Droxia.
Study Arms  ICMJE
  • Experimental: SANGUINATE™
    PEG-bHb-CO
    Intervention: Biological: SANGUINATE™
  • Active Comparator: Hydroxyurea
    Standard of care for Sickle Cell treatment, 15 mg/kg.
    Intervention: Drug: Hydroxyurea
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 3, 2013)
24
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 19 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Colombia,   Panama
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01848925
Other Study ID Numbers  ICMJE SGSC-003
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Prolong Pharmaceuticals
Study Sponsor  ICMJE Prolong Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account Prolong Pharmaceuticals
Verification Date December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP