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

Malaria, Falciparum Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01442168
• Other study ID #: Sevuparin/DF02_TSM02
• Status: Terminated
• Phase: Phase 1/Phase 2
• First received: September 23, 2011
• Last updated: August 18, 2014
• Start date: September 2011
• Est. completion date: January 2014

Study information

• Verified date: August 2014
• Source: Dilaforette AB
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ministry of Public Health
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 53
• Est. completion date: January 2014
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Malaria
• Malaria, Falciparum

Intervention

Drug:
• Sevuparin sodium + atovaquone/proquanil
Sevuparin 4 times per day and malanil according to label
• atovaquone/proquanil
malanil according to label

Locations

Country	Name	City	State
Thailand	Hospital for Tropical Diseases	Bangkok
Thailand	Mae Ramat Hospital	Mae Ramat	Tak province
Thailand	Maesot General hospital	Mae Sot	Tak Province

Sponsors (2)

Lead Sponsor	Collaborator
Dilaforette AB	University of Oxford

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dose limiting toxicities according to specified criteria		During treatment and 14 days post treatment follow-up.	Yes
Primary	Area under the curve of late stage peripheral blood parasitemia over time (Part 2).		72 hours	No