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| Name | Class |
|---|---|
| University of Oxford | OTHER |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sevuparin/DF02 | Experimental | Sevuparin/DF02 plus anti-malarial regimen (Malanil®) |
|
| Control | Active Comparator | Anti-malarial regimen (Malanil®) alone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sevuparin sodium + atovaquone/proquanil | Drug | Sevuparin 4 times per day and malanil according to label |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dose limiting toxicities according to specified criteria | During treatment and 14 days post treatment follow-up. | |
| Area under the curve of late stage peripheral blood parasitemia over time (Part 2). | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anna Leitgeb, PhD | Modus Therapeutics AB | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mae Ramat Hospital | Mae Ramat | Changwat Tak | Thailand | |||
| Maesot General hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29244851 | Derived | 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. |
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| ID | Term |
|---|---|
| D016778 | Malaria, Falciparum |
| ID | Term |
|---|---|
| D008288 | Malaria |
| D011528 | Protozoan Infections |
| D010272 | Parasitic Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D053626 | Atovaquone |
| ID | Term |
|---|---|
| D009285 | Naphthoquinones |
| D011809 | Quinones |
| D009930 | Organic Chemicals |
| D009281 | Naphthalenes |
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| atovaquone/proquanil | Drug | malanil according to label |
|
| Mae Sot |
| Changwat Tak |
| Thailand |
| Hospital for Tropical Diseases | Bangkok | Thailand |
| D000096724 |
| Mosquito-Borne Diseases |
| D000079426 | Vector Borne Diseases |
| D011084 |
| Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |