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Completed

NCT Number: NCT01848925

Study of SANGUINATE™ 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.

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Key information

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Fundacion BIOS, Barranquilla, Colombia

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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;

Treatment and study plan

SANGUINATE™

Biological

40 mg/mL intravenous infusion.

Hydroxyurea

Drug

Standard of care for Sickle Cell treatment, 15 mg/kg.

Other names: Hydroxycarbamide, Brand Names includes: Hydria, Droxia.

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Prolong Pharmaceuticals

Industry

Registry information

Official study 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.

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
May 8, 2013
Registry last updated
Dec 3, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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