Clinical Trial: Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: 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 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).
Detailed Summary:
Sponsor: Modus Therapeutics AB
Current Primary Outcome:
- Dose limiting toxicities according to specified criteria [ Time Frame: During treatment and 14 days post treatment follow-up. ]
- Area under the curve of late stage peripheral blood parasitemia over time (Part 2). [ Time Frame: 72 hours ]
Original Primary Outcome:
- Safety and tolerability (Part 1) [ Time Frame: During treatment and 14 days post treatment follow-up. ]Frequency and severity of adverse events, abnormal changes in vital signs and laboratory parameters.
- Area under the curve of late stage peripheral blood parasitemia over time (Part 2). [ Time Frame: 72 hours ]
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Modus Therapeutics AB
Dates:
Date Received: September 23, 2011
Date Started: September 2011
Date Completion:
Last Updated: August 18, 2014
Last Verified: August 2014
