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

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01442168

Enrollment

Registered

2011-09-28

Start date

2011-09-30

Completion date

2014-01-31

Last updated

2014-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malaria, Falciparum

Keywords

Uncomplicated Falciparum Malaria, Plasmodium falciparum, Antimalarial treatment, Sevuparin/DF02, Adjuvant therapy, Malanil, Peripheral blood parasitemia, Rosette formation, Maximum tolerated dose

Brief 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).

Interventions

DRUGSevuparin sodium + atovaquone/proquanil

Sevuparin 4 times per day and malanil according to label

DRUGatovaquone/proquanil

malanil according to label

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
Dose limiting toxicities according to specified criteria	During treatment and 14 days post treatment follow-up.
Area under the curve of late stage peripheral blood parasitemia over time (Part 2).	72 hours

Countries

Thailand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 25, 2026