A clinical trial to study the effect of low anticoagulant heparin (sevuparin/DF02) as an adjuvant therapy in malaria patients.
- Conditions
- Health Condition 1: null- Moderate to severe P. falciparum Malaria
- Registration Number
- CTRI/2012/11/003138
- Lead Sponsor
- Dilaforette AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Other (Terminated)
- Sex
- Not specified
- Target Recruitment
- 20
1. Male or female, 18 to 65 years old, inclusive
2. P. falciparum infection, confirmed by positive blood smear
3. Counts of asexual forms of P. falciparum >= 1,000 parasites/μl
4. Diagnosis of severe malaria according to WHO criteria for severe malaria 2010 (Appendix 19.3) or severe prostration (defined as extreme weakness,inability to walk or sit up without assistance or impaired consciousness with behavioural changes, confusion or drowsiness)
5. Written informed consent
1. Jaundice (defined as total serum bilirubin >3 mg/dL) with no other clinical symptoms of severe malaria
2. Severe anaemia (haemoglobin <=5 g/dL) and peripheral parasitemia < 100.000 parasites/μL, with no other clinical symptoms of severe malaria
3. Known hypersensitivity to the IMP or any of the excipients or to medicinal products with similar chemical structures (i.e. heparin or LMWHs)
4. History of significant bleeding (e.g. upper GI bleeding, recurrent epistaxis, joint bleeding, melena)
5. History of heparin induced thrombocytopenia (HIT)
6. Any known severe or debilitating chronic disease
7. History of splenectomy
8. For females: pregnancy, lactating or intention of becoming pregnant within the expected duration of the study (28 days)
9. Thrombocytopenia < 50 x 109/L
10. Liver function tests (ASAT/ALAT levels) more than 2.5 times the upper limit of normal range
11. Documented adequate parenteral antimalarial treatment for >= 24 hours prior to admission
12. Patients with known human immunodeficiency virus (HIV) infection
13. Participation in another clinical trial within 30 days
14. An APTT value >1.5 x ULN
15. Current long-term treatment with Non-Steroidal Anti-Inflammatory Drugs (NSAIDs)
16. Use of any of the following medications within the past 1 week: Aspirin, Clopidogrel, Dipyridamole or Warfarin
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary objective is to evaluate the safety and tolerability of sevuparin/DF02 when administered IV every 6 hours until patient recovery or until start of oral medication for a maximum of 3 consecutive days (minimum 5 doses) as adjunctive therapy to IV artesunate in patients with moderate to severe P. falciparum malaria. <br/ ><br> <br/ ><br>Safety and tolerability will be assessed by observing occurrence and frequency of relevant adverse <br/ ><br>eventsTimepoint: The primary outcome will be measured in each study visit as follows : <br/ ><br>Day 1 <br/ ><br>Day 2 <br/ ><br>Day 3 <br/ ><br>Daily until discharge <br/ ><br>Day 7 <br/ ><br>Day 14 <br/ ><br>Day 28
- Secondary Outcome Measures
Name Time Method