Cohort Event Monitoring Study of Pyramax®
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|ClinicalTrials.gov Identifier: NCT03201770|
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : June 26, 2019
|Condition or disease||Intervention/treatment||Phase|
|Malaria,Falciparum||Drug: pyronaridine artesunate||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||8572 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||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®|
|Actual Study Start Date :||June 22, 2017|
|Actual Primary Completion Date :||April 10, 2019|
|Actual Study Completion Date :||April 10, 2019|
Pyronaridine artesunate tablets (180/60mg) and granules (60/20mg)
Drug: pyronaridine artesunate
Other Name: Pyramax
- Evaluation and identification of hepatic safety events, including raised liver function tests [ Time Frame: Assessment up to Day 28. ]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.
- Overall safety [ Time Frame: Assessment up to Day 28. ]Evaluation of the adverse event reporting of Pyramax in the treatment of uncomplicated malaria under real life conditions.
- Evaluation of Efficacy [ Time Frame: Assessment up to Day 28. ]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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03201770
|The Biotechnology Center Nkolbisson, Univ of Yaounde I, Messa|
|Congo, The Democratic Republic of the|
|Centre de Recherche du Centre Hospitalier du Mont Amba|
|Kinshasa, Congo, The Democratic Republic of the, XI|
|Centre de Santé FCRM, Hospital of Talangai|
|Institut Pierre Richet / Institut National de SanPublique (IPR/INSP)|
|Bouaké, Côte D'Ivoire, BP 1500|
|CERMEL, Albert Schweitzer Hospital|
|Lambaréné, Gabon, BP 118|
|Principal Investigator:||Michael Ramharter, MD, DTM&H||CERMEL, University of Tübingen, Germany|