Clinical trial NCT01442168: Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
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 Falciparum Malaria
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Malaria, Falciparum
Keywords: Uncomplicated Falciparum Malaria
Plasmodium falciparum
Antimalarial treatment
Sevuparin/DF02
Adjuvant therapy
Malanil
Peripheral blood parasitemia
Rosette formation
Maximum tolerated dose
Lead sponsor: Modus Therapeutics AB
Sponsor class: INDUSTRY
Collaborators: name: University of Oxford
First posted: 2011-09-28
Enrollment: 53
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility 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

Primary outcomes:
measure: Dose limiting toxicities according to specified criteria
timeFrame: During treatment and 14 days post treatment follow-up.
measure: Area under the curve of late stage peripheral blood parasitemia over time (Part 2).
timeFrame: 72 hours
Secondary outcomes:
Other outcomes:
Locations:
city: Mae Ramat
country: Thailand
facility: Mae Ramat Hospital
state: Tak province
city: Mae Sot
country: Thailand
facility: Maesot General hospital
state: Tak Province
city: Bangkok
country: Thailand
facility: Hospital for Tropical Diseases
Study officials:
affiliation: Modus Therapeutics AB
name: Anna Leitgeb, PhD
role: STUDY_DIRECTOR
References:
citation: Leitgeb AM, Charunwatthana P, Rueangveerayut R, Uthaisin C, Silamut K, Chotivanich K, Sila P, Moll K, Lee SJ, Lindgren M, Holmer E, Farnert A, Kiwuwa MS, Kristensen J, Herder C, Tarning J, Wahlgren M, Dondorp AM. Inhibition of merozoite invasion and transient de-sequestration by sevuparin in humans with Plasmodium falciparum malaria. PLoS One. 2017 Dec 15;12(12):e0188754. doi: 10.1371/journal.pone.0188754. eCollection 2017.