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

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ClinicalTrials.gov Identifier: NCT01442168
Recruitment Status : Terminated
First Posted : September 28, 2011
Last Update Posted : August 19, 2014
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Modus Therapeutics AB

September 23, 2011
September 28, 2011
August 19, 2014
September 2011
September 2013   (Final data collection date for primary outcome measure)
  • Dose limiting toxicities according to specified criteria [ Time Frame: During treatment and 14 days post treatment follow-up. ]
  • Area under the curve of late stage peripheral blood parasitemia over time (Part 2). [ Time Frame: 72 hours ]
  • Safety and tolerability (Part 1) [ Time Frame: During treatment and 14 days post treatment follow-up. ]
    Frequency and severity of adverse events, abnormal changes in vital signs and laboratory parameters.
  • Area under the curve of late stage peripheral blood parasitemia over time (Part 2). [ Time Frame: 72 hours ]
Complete list of historical versions of study NCT01442168 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
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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

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).

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Malaria, Falciparum
  • Drug: Sevuparin sodium + atovaquone/proquanil
    Sevuparin 4 times per day and malanil according to label
  • Drug: atovaquone/proquanil
    malanil according to label
  • Experimental: Sevuparin/DF02
    Sevuparin/DF02 plus anti-malarial regimen (Malanil®)
    Intervention: Drug: Sevuparin sodium + atovaquone/proquanil
  • Active Comparator: Control
    Anti-malarial regimen (Malanil®) alone
    Intervention: Drug: atovaquone/proquanil
Leitgeb AM, Charunwatthana P, Rueangveerayut R, Uthaisin C, Silamut K, Chotivanich K, Sila P, Moll K, Lee SJ, Lindgren M, Holmer E, Färnert 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
53
95
January 2014
September 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Thailand
 
 
NCT01442168
Sevuparin/DF02_TSM02
Yes
Not Provided
Not Provided
Modus Therapeutics AB
Modus Therapeutics AB
University of Oxford
Study Director: Anna Leitgeb, PhD Modus Therapeutics AB
Modus Therapeutics AB
August 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP