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

August 18, 2014 updated by: Modus Therapeutics AB

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).

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
      • Bangkok, Thailand
        • Hospital for Tropical Diseases
    • Tak Province
      • Mae Sot, Tak Province, Thailand
        • Maesot General hospital
    • Tak province
      • Mae Ramat, Tak province, Thailand
        • Mae Ramat Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Sevuparin/DF02
Sevuparin/DF02 plus anti-malarial regimen (Malanil®)
Drug: Sevuparin sodium + atovaquone/proquanil
Sevuparin 4 times per day and malanil according to label
Active Comparator: Control
Anti-malarial regimen (Malanil®) alone
Drug: atovaquone/proquanil
malanil according to label

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dose limiting toxicities according to specified criteria
Time Frame: During treatment and 14 days post treatment follow-up.
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
72 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Modus Therapeutics AB

Collaborators

University of Oxford

Investigators

  • Study Director: Anna Leitgeb, PhD, Modus Therapeutics AB

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

January 1, 2014

Study Registration Dates

First Submitted

September 23, 2011

First Submitted That Met QC Criteria

September 27, 2011

First Posted (Estimate)

September 28, 2011

Study Record Updates

Last Update Posted (Estimate)

August 19, 2014

Last Update Submitted That Met QC Criteria

August 18, 2014

Last Verified

August 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sevuparin/DF02_TSM02

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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