A Phase 4 interventional study of pyronaridine artesunate in Malaria,Falciparum, sponsored by Shin Poong Pharmaceutical Co. Ltd.. Completed at 5 sites in 5 countries. Open to participants aged 3 Months and older. Per ClinicalTrials.gov, last updated 2019-06-26.
Sponsored by Shin Poong Pharmaceutical Co. Ltd. · Phase 4, Interventional, and Treatment
The study is to be performed in public health facilities in Central and West Africa where Pyramax will be used as treatment of uncomplicated malaria episodes, including repeat episodes. The study is to assess the safety of Pyramax, particularly in patients with underlying liver function abnormalities, in patients who have co-morbid conditions, such as HIV, and also in very small children (\<1 year of age).
This is a non-comparative Cohort Event Monitoring study. The study will assess the safety of Pyramax in terms of the evaluation and identification of the hepatic safety events in a sub group of patients enrolled with liver function tests (LFT)s >2x upper limit of normal (ULN) from blood taken immediately prior to treatment without any clinical signs or symptoms of hepatotoxicity and with signs and symptoms of uncomplicated malaria confirmed by a Rapid Diagnostic Test (RDT) or microscopy (thick blood smear). The study will compare the clinical hepatic safety of Pyramax between a cohort of patients enrolled with LFTs >2xULN and a cohort of patients enrolled with normal LFTs matched for demographic characteristics.
An estimated 8,572 malaria episodes are to be recruited to provide 120 malaria episodes in patients with baseline raised LFTs >2xULN for follow up of liver function. A cohort of at least 2% of children who are \<1 year of age will be included for monitoring of liver function.
Uncomplicated malaria (Plasmodia of any species) diagnosed as per national policies and in line with WHO recommendations:
Exclusion Criteria:
Pyronaridine artesunate tablets (180/60mg) and granules (60/20mg)
Drug: pyronaridine artesunate
Antimalarial treatment
Also known as: Pyramax
Evaluation and identification of hepatic safety events, including raised liver function tests
Evaluation and identification of hepatic safety events (including raised liver function tests - LFTs) of Pyramax in a sub group of malaria patients enrolled with LFTs \>2xUL.
Time frame: Assessment up to Day 28.
Overall safety
Evaluation of the adverse event reporting of Pyramax in the treatment of uncomplicated malaria under real life conditions.
Time frame: Assessment up to Day 28.
Evaluation of Efficacy
Evaluation of the efficacy based on crude Day 28 cure rate by species and PCR adjusted cure rate for Day 28 cure rate for P. falciparum of Pyramax in the treatment of uncomplicated malaria under real life conditions
Time frame: Assessment up to Day 28.
Plan to share: No
This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.
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Shin Poong Pharmaceutical Co. Ltd.