Trials / Completed
CompletedNCT01848925
Study of SANGUINATE™ Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients
A Phase I Open-label, Randomized, Safety and Efficacy Study of SANGUINATE™ at Two Doses Levels Versus Hydroxyurea in Sickle Cell Disease (SCD) Patients.
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Prolong Pharmaceuticals · Industry
- Sex
- All
- Age
- 19 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to compare the safety of SANGUINATE™ versus Hydroxyurea in patients suffering from Sickle Cell Disease.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SANGUINATE™ | 40 mg/mL intravenous infusion. |
| DRUG | Hydroxyurea | Standard of care for Sickle Cell treatment, 15 mg/kg. |
Timeline
- Start date
- 2013-05-01
- Primary completion
- 2014-07-01
- Completion
- 2014-08-01
- First posted
- 2013-05-08
- Last updated
- 2014-12-03
Locations
4 sites across 2 countries: Colombia, Panama
Source: ClinicalTrials.gov record NCT01848925. Inclusion in this directory is not an endorsement.