Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
Primary Purpose
Malaria, Falciparum
Status
Terminated
Phase
Phase 1
Locations
Thailand
Study Type
Interventional
Intervention
Sevuparin sodium + atovaquone/proquanil
atovaquone/proquanil
Sponsored by
About this trial
This is an interventional treatment trial for Malaria, Falciparum focused on measuring Uncomplicated Falciparum Malaria, Plasmodium falciparum, Antimalarial treatment, Sevuparin/DF02, Adjuvant therapy, Malanil, Peripheral blood parasitemia, Rosette formation, Maximum tolerated dose
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
Sites / Locations
- Mae Ramat Hospital
- Maesot General hospital
- Hospital for Tropical Diseases
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Sevuparin/DF02
Control
Arm Description
Sevuparin/DF02 plus anti-malarial regimen (Malanil®)
Anti-malarial regimen (Malanil®) alone
Outcomes
Primary Outcome Measures
Dose limiting toxicities according to specified criteria
Area under the curve of late stage peripheral blood parasitemia over time (Part 2).
Secondary Outcome Measures
Full Information
NCT ID
NCT01442168
First Posted
September 23, 2011
Last Updated
August 18, 2014
Sponsor
Modus Therapeutics AB
Collaborators
University of Oxford
1. Study Identification
Unique Protocol Identification Number
NCT01442168
Brief Title
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
2. Study Status
Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Study Start Date
September 2011 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
January 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Modus Therapeutics AB
Collaborators
University of Oxford
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Malaria, Falciparum
Keywords
Uncomplicated Falciparum Malaria, Plasmodium falciparum, Antimalarial treatment, Sevuparin/DF02, Adjuvant therapy, Malanil, Peripheral blood parasitemia, Rosette formation, Maximum tolerated dose
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Sevuparin/DF02
Arm Type
Experimental
Arm Description
Sevuparin/DF02 plus anti-malarial regimen (Malanil®)
Arm Title
Control
Arm Type
Active Comparator
Arm Description
Anti-malarial regimen (Malanil®) alone
Intervention Type
Drug
Intervention Name(s)
Sevuparin sodium + atovaquone/proquanil
Intervention Description
Sevuparin 4 times per day and malanil according to label
Intervention Type
Drug
Intervention Name(s)
atovaquone/proquanil
Intervention Description
malanil according to label
Primary Outcome Measure Information:
Title
Dose limiting toxicities according to specified criteria
Time Frame
During treatment and 14 days post treatment follow-up.
Title
Area under the curve of late stage peripheral blood parasitemia over time (Part 2).
Time Frame
72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anna Leitgeb, PhD
Organizational Affiliation
Modus Therapeutics AB
Official's Role
Study Director
Facility Information:
Facility Name
Mae Ramat Hospital
City
Mae Ramat
State/Province
Tak province
Country
Thailand
Facility Name
Maesot General hospital
City
Mae Sot
State/Province
Tak Province
Country
Thailand
Facility Name
Hospital for Tropical Diseases
City
Bangkok
Country
Thailand
12. IPD Sharing Statement
Citations:
PubMed Identifier
29244851
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.
Results Reference
derived
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Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria
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