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

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 26, 2014