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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
Modus Therapeutics AB
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

First Posted
September 23, 2011
Last Updated
August 18, 2014
Sponsor
Modus Therapeutics AB
Collaborators
University of Oxford
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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
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Sevuparin/DF02 as an Adjunctive Therapy in Subjects Affected With Uncomplicated Falciparum Malaria

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