Trial | NCT01442168  Report issue

Title

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

  • Phase

    Phase 1/Phase 2

  • Study Type

    Interventional

  • Status

    Terminated

  • Study Participants

    53
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).
Study Started
Sep 30
2011
Primary Completion
Sep 30
2013
Study Completion
Jan 31
2014
Last Update
Aug 19
2014
Estimate

Drug Sevuparin sodium + atovaquone/proquanil

Sevuparin 4 times per day and malanil according to label

Drug atovaquone/proquanil

malanil according to label

Sevuparin/DF02 Experimental

Sevuparin/DF02 plus anti-malarial regimen (Malanil®)

Control Active Comparator

Anti-malarial regimen (Malanil®) alone

Criteria 

Inclusion Criteria:

Presence of acute uncomplicated P. falciparum malaria, confirmed by positive blood smear with asexual forms of a single species (P. falciparum)
Counts of asexual forms of P. falciparum: 10 000- 100 000/ul with or without gametocytaemia
Presence of fever defined as > 38°C tympanic temperature or a history of fever within the last 24 hours

Exclusion Criteria:

Mixed infection with other Plasmodium species
Any criteria of severe or complicated malaria as defined by the WHO, 2010
Use of high doses aspirin (more than 100 mg/day) or dual anti-platelet therapy or use of heparin,Low Molecular Weight Heparin (LMWH) or warfarin
Presence of significant anemia as defined by Hb <8 g/dL or Hct < 25%
A platelet count < 50,000/μL
Presence of febrile conditions caused by diseases other than malaria
No Results Posted