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

This study is currently recruiting participants.
Verified February 2013 by Dilaforette AB
Sponsor:
Collaborator:
University of Oxford
Information provided by (Responsible Party):
Dilaforette AB
ClinicalTrials.gov Identifier:
NCT01442168
First received: September 23, 2011
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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).


Condition Intervention Phase
Malaria, Falciparum
Drug: Sevuparin sodium + atovaquone/proquanil
Drug: atovaquone/proquanil
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Dilaforette AB:

Primary Outcome Measures:
  • Dose limiting toxicities according to specified criteria [ Time Frame: During treatment and 14 days post treatment follow-up. ] [ Designated as safety issue: Yes ]
  • Area under the curve of late stage peripheral blood parasitemia over time (Part 2). [ Time Frame: 72 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 95
Study Start Date: September 2011
Estimated Study Completion Date: October 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01442168

Contacts
Contact: Arjen Dondorp, MD, PhD arjen@tropmedres.ac

Locations
Thailand
Mae Ramat Hospital Recruiting
Mae Ramat, Tak province, Thailand
Contact: Chirapong Uthaisin, MD       chirpong@yahoo.co.th   
Principal Investigator: Chirapong Uthaisin, MD         
Maesot General hospital Recruiting
Mae Sot, Tak Province, Thailand
Contact: Ronnatrai Rueangveerayuth, MD, FM, BSc       ronnatrai@yahoo.com   
Principal Investigator: Ronnatrai Rueangveerayuth, MD, FM, BSc         
Hospital for Tropical Diseases Not yet recruiting
Bangkok, Thailand
Contact: Prakaykaew Charunwatthana, PhD       Jib@tropmedres.ac   
Principal Investigator: Prakaykaew Charunwatthana, MD         
Sponsors and Collaborators
Dilaforette AB
University of Oxford
Investigators
Study Director: Anna Leitgeb, PhD Dilaforette AB
  More Information

No publications provided

Responsible Party: Dilaforette AB
ClinicalTrials.gov Identifier: NCT01442168     History of Changes
Other Study ID Numbers: Sevuparin/DF02_TSM02
Study First Received: September 23, 2011
Last Updated: February 26, 2013
Health Authority: Thailand: Ministry of Public Health

Keywords provided by Dilaforette AB:
Uncomplicated Falciparum Malaria
Plasmodium falciparum
Antimalarial treatment
Sevuparin/DF02
Adjuvant therapy
Malanil
Peripheral blood parasitemia
Rosette formation
Maximum tolerated dose

Additional relevant MeSH terms:
Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Antimalarials
Atovaquone
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on April 14, 2014