NCT01442168

Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria

A Phase I/II, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study of Sevuparin/DF02, as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: Modus Therapeutics AB · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to determine the tolerability and pharmacokinetics of Sevuparin/DF02 when administered as an i.v. infusion in combination with Malanil® (atovaquone/proguanil) as anti-malarial treatment in subjects affected with uncomplicated malaria. The study will also assess the potential of Sevupatin/DF02 to reduce infected erythrocyte sequestration and rosette formation. The study consists of a dose escalation part (part 1) followed by an open labelled, randomized comparison of treatment with Sevuparin/DF02 and Malanil® versus Malanil® alone (part 2).

Conditions

• Malaria, Falciparum

Interventions

Type	Name	Description
DRUG	Sevuparin sodium + atovaquone/proquanil	Sevuparin 4 times per day and malanil according to label
DRUG	atovaquone/proquanil	malanil according to label

Timeline

• Start date: 2011-09-01
• Primary completion: 2013-09-01
• Completion: 2014-01-01
• First posted: 2011-09-28
• Last updated: 2014-08-19

Locations

3 sites across 1 country: Thailand