Cohort Event Monitoring Study of Pyramax®

Shin Poong Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Malaria,Falciparum

Treatments

Drug: pyronaridine artesunate

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT03201770

SP-C-021-15

Details and patient eligibility

About

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).

Full 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.

Enrollment

8,572 patients

Sex

All

Ages

3+ months old

Volunteers

No Healthy Volunteers

Inclusion criteria

Uncomplicated malaria (Plasmodia of any species) diagnosed as per national policies and in line with WHO recommendations:
- Fever or history of fever in the previous 24 h and/or the presence of anaemia, for which pallor of the palms appears to be the most reliable sign in young children.
- Confirmation of malaria by a parasitological diagnosis (RDT or Microscopy (thick blood smear). analysis).
Weight ≥5 kg - < 20 kg (granules); ≥20 kg (tablets).
Ability to take an oral medication.
Ability and willingness to participate based on signed informed consent (a parent or a guardian has to sign for children below 18 years old) and on signed assent form for minors that could be required per national regulations in each participating country.
The patient has to comply with all scheduled follow-up visits.

Exclusion criteria

Patients with clinical signs or symptoms of hepatic injury (such as nausea, abdominal pain associated with jaundice) or known severe liver disease (i.e. decompensated cirrhosis, Child-Pugh stage 3 or 4).
Known allergy to artemisinin and/or to pyronaridine.
Known pregnancy.
Lactating women should be excluded if other anti-malarial treatments are available.
Complicated malaria as per WHO definition (Annex 2)
Patients that the investigator considers would be at particular risk if receiving an anti-malarial or if participating in the study.
Patients having been treated with Pyramax in the previous 28 days.