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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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22 February 2021 |
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Main ID: |
NCT02614404 |
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Date of registration:
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16/11/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria
MIM |
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Scientific title:
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Effect of Imatinib on Suppression of Malaria Parasites in Patients With Uncomplicated Plasmodium Falciparum Malaria |
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Date of first enrolment:
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November 2015 |
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Target sample size:
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15 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02614404 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Phase 1
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Countries of recruitment
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Vietnam
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Contacts
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Name:
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Huynh D Chien, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hue University |
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Name:
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Francesco M Turrini, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Turin, Italy |
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Name:
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Philip S Low, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Purdue University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Gender: only adults are selected for the trial; note that female subjects cannot be
women of child-bearing age.
- Age: 18-50 years.
- Target disease: Uncomplicated Plasmodium falciparum malaria
Exclusion Criteria:
- symptoms and signs of complicated malaria
- including continuous high fever of over 390C, psychiatric disorders, confusion, other
neurological symptoms, symptoms and signs of functional impairment of the organs such
as lungs, kidneys or cardiovascular system;
- symptoms and signs of liver damage or kidney damage
- symptoms and signs of another complicating infection such as pneumonia, dengue fever,
and other bacterial infection.
- P. falciparum > 25.000 / mm3
- WBC <4000 and >10.000 /mm3
- RBC < 3.5x106/mm3
- Platelets < 40.000 /mm3
- Hemoglobin < 10 g/dL
- ALT more than 200% of the upper limit (56 units/L)
- AST more than 200% of the upper limit (40 units/L)
- Blood creatine more than 75% of the upper limit (men: 1.2 mg/dL, women 1 mgdL)
- Serum total protein < 6 g/L
- Glycemia < 50 mg/dL> 200 mg/dL
- Standard urine test Serious alterations
- Concomitant treatments
Antimalarial Drugs Anticoagulant therapy
Age minimum:
18 Years
Age maximum:
50 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Plasmodium Falciparum Malaria
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Intervention(s)
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Drug: Dihydroartemisinin-piperaquine
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Drug: Imatinib combination therapy
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Primary Outcome(s)
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28-day Cure Rate
[Time Frame: Day 28]
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Time to Parasite Clearance
[Time Frame: From baseline to the time point when the blood parasite count is zero (up to a maximum of 5 days)]
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Secondary Outcome(s)
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Frequency of adverse events
[Time Frame: Within 1 week of beginning treatment with imatinib]
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Secondary ID(s)
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HuLow-201605
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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