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

Sickle Cell Disease Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01848925
• Other study ID #: SGSC-003
• Status: Completed
• Phase: Phase 1
• First received: April 23, 2013
• Last updated: December 2, 2014
• Start date: May 2013
• Est. completion date: August 2014

Study information

• Verified date: December 2014
• Source: Prolong Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Colombia: INVIMA Instituto Nacional de Vigilancia de Medicamentos y AlimentosPanama: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: August 2014
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia, Sickle Cell
• Sickle Cell Disease

Intervention

Biological:
• SANGUINATE™
40 mg/mL intravenous infusion.

Drug:
• Hydroxyurea
Standard of care for Sickle Cell treatment, 15 mg/kg.

Locations

Country	Name	City	State
Colombia	Fundacion BIOS	Barranquilla
Colombia	Fundacion Reina Isabel	Cali
Colombia	Hospital Pablo TobinUribe	Medellin
Panama	PAMRI	Panama City

Sponsors (1)

Lead Sponsor	Collaborator
Prolong Pharmaceuticals

Countries where clinical trial is conducted

Colombia,  Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To Compare SANGUINATE™ and Hydroxyurea in Sickle Cell Disease patients.	Compare pain management between SANGUINATE™ and Hydroxyurea using 0-10 Numeric Pain Scale.	7 days	Yes