NCT01442168

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).

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Sep 2011

Typical duration for phase_1

Geographic Reach
1 country

3 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
22 days until next milestone

First Submitted

Initial submission to the registry

September 23, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 28, 2011

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2014

Completed
Last Updated

August 19, 2014

Status Verified

August 1, 2014

Enrollment Period

2 years

First QC Date

September 23, 2011

Last Update Submit

August 18, 2014

Conditions

Malaria, Falciparum

Keywords

Uncomplicated Falciparum MalariaPlasmodium falciparumAntimalarial treatmentSevuparin/DF02Adjuvant therapyMalanilPeripheral blood parasitemiaRosette formationMaximum tolerated dose

Outcome Measures

Primary Outcomes (2)

  • 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

Study Arms (2)

Sevuparin/DF02

EXPERIMENTAL

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

Drug: Sevuparin sodium + atovaquone/proquanil

Control

ACTIVE COMPARATOR

Anti-malarial regimen (Malanil®) alone

Drug: atovaquone/proquanil

Interventions

Sevuparin sodium + atovaquone/proquanilDRUG

Sevuparin 4 times per day and malanil according to label

Sevuparin/DF02
atovaquone/proquanilDRUG

malanil according to label

Control

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

Mae Ramat Hospital

Mae Ramat, Changwat Tak, Thailand

Location

Maesot General hospital

Mae Sot, Changwat Tak, Thailand

Location

Hospital for Tropical Diseases

Bangkok, Thailand

Location

Related Publications (1)

  • 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.

    PMID: 29244851DERIVED

MeSH Terms

Conditions

Malaria, Falciparum

Interventions

Atovaquone

Condition Hierarchy (Ancestors)

MalariaProtozoan InfectionsParasitic DiseasesInfectionsMosquito-Borne DiseasesVector Borne Diseases

Intervention Hierarchy (Ancestors)

NaphthoquinonesQuinonesOrganic ChemicalsNaphthalenesPolycyclic Aromatic HydrocarbonsPolycyclic Compounds

Study Officials

  • Anna Leitgeb, PhD

    Modus Therapeutics AB

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 23, 2011

First Posted

September 28, 2011

Study Start

September 1, 2011

Primary Completion

September 1, 2013

Study Completion

January 1, 2014

Last Updated

August 19, 2014

Record last verified: 2014-08

Locations

TH(3)