NCT03201770

Cohort Event Monitoring Study of Pyramax®

Phase IIIb/IV Cohort Event Monitoring Study To Evaluate, In Real Life Setting, The Safety And Tolerability In Malaria Patients Of The Fixed-Dose Artemisinin-Based Combination Therapy Pyramax®

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 8,572 (actual)
• Sponsor: Shin Poong Pharmaceutical Co. Ltd. · Industry
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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.

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
DRUG	pyronaridine artesunate	Antimalarial treatment

Timeline

• Start date: 2017-06-22
• Primary completion: 2019-04-10
• Completion: 2019-04-10
• First posted: 2017-06-28
• Last updated: 2019-06-26

Locations

5 sites across 5 countries: Cameroon, Côte d’Ivoire, Democratic Republic of the Congo, Gabon, Republic of the Congo