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

Modus Therapeutics

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Malaria, Falciparum

Treatments

Drug: atovaquone/proquanil

Drug: Sevuparin sodium + atovaquone/proquanil

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT01442168

Sevuparin/DF02_TSM02

Details and patient eligibility

About

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).

Enrollment

53 patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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