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

Phase 1

Terminated

• Conditions: Malaria, Falciparum
• Interventions: Drug: atovaquone/proquanil; Drug: Sevuparin sodium + atovaquone/proquanil

• Registration Number: NCT01442168
• Lead Sponsor: Modus Therapeutics AB

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2011-09
• Study First Submitted: 2011-09-23
• Study First Submitted QC: 2011-09-27
• Study First Posted: 2011-09-28
• Primary Completion: 2013-09
• Study Completion: 2014-01
• Status Verified: 2014-08
• Last Update Submitted: 2014-08-18
• Last Update Posted: 2014-08-19

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 53

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	atovaquone/proquanil	Anti-malarial regimen (Malanil®) alone
Sevuparin/DF02	Sevuparin sodium + atovaquone/proquanil	Sevuparin/DF02 plus anti-malarial regimen (Malanil®)

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (3)

Mae Ramat Hospital; 🇹🇭 Mae Ramat, Tak province, Thailand

Maesot General hospital; 🇹🇭 Mae Sot, Tak Province, Thailand

Hospital for Tropical Diseases; 🇹🇭 Bangkok, Thailand