NCT02600390

SANGUINATE™ in Sickle Cell Disease Associated Leg Ulcer

An Open-label, Repeated-dose, Dose Escalation Study of the Safety and Effectiveness of SANGUINATE™ for the Treatment of Leg Ulcers in Adult Patients With Sickle Cell Disease

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Prolong Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

SANGUINATE™ Sickle Cell Disease associated Leg Ulcers.

Detailed description

This is an escalating, repeated-dose, open-label Phase 2 study to test SANGUINATE (pegylated carboxyhemoglobin bovine) in patients suffering from leg ulceration associated with Sickle Cell Disease (SCD leg ulcer). Patients will undergo consent and screening procedures at the time of presentation for leg ulcer treatment. Eligible patients will begin a 3-week Run-In Period. A total of approximately fifteen (15) patients are expected to be screened in order to achieve an enrollment target of ten (10) evaluable patients for participation in the study. Evaluable is defined as a patient receiving a minimum of three doses of investigational product. Five (5) patients (Cohort 1) will receive four (4) once-weekly 2-hour IV infusions of SANGUINATE at a dose of 320 mg/kg (8 mL). An additional five (5) patients (Cohort 2) will receive six (6) once-weekly 2-hour IV infusions of SANGUINATE also at a dose of 320 mg/kg. Each patient will be contacted by telephone approximately 24 hours after dosing to verify the safety status of the patient. One week following the Treatment Phase, patients will return to the study center for a Final Visit where safety assessments will be performed. During the Final Visit, patients will receive standard of care treatment of ulcer. All patients will receive once-weekly Standard of Care (SOC) therapy for SCD leg ulcer for the duration of the study. SOC includes dressing the wound with multi-layer, short stretch, compression bandaging. Non-adherent, medical-grade foam will be used as the wound contact layer and primary dressing.

Conditions

• Leg Ulcer

Interventions

Type	Name	Description
BIOLOGICAL	SANGUINATE	A two-hour infusion provided once a week over a 4-week or 6-week period.

Timeline

• Start date: 2016-03-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2015-11-09
• Last updated: 2017-02-28

Locations

2 sites across 2 countries: Dominican Republic, Panama