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:
Dilaforette AB
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
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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 May 23, 2013