Cohort Event Monitoring Study of Pyramax®

Sponsor

Shin Poong Pharmaceutical Co. Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT03201770

Collaborator

Medicines for Malaria Venture (Other)

8,572

Enrollment

Locations

Arm

21.6

Actual Duration (Months)

1714.4

Patients Per Site

79.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease	Intervention/Treatment	Phase
Malaria,Falciparum	Drug: pyronaridine artesunate	Phase 4

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

8572 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 :

Jun 22, 2017

Actual Primary Completion Date :

Apr 10, 2019

Actual Study Completion Date :

Apr 10, 2019

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pyramax Pyronaridine artesunate tablets (180/60mg) and granules (60/20mg)	Drug: pyronaridine artesunate Antimalarial treatment Other Names: Pyramax

Arm

Intervention/Treatment

Experimental: Pyramax

Pyronaridine artesunate tablets (180/60mg) and granules (60/20mg)

Drug: pyronaridine artesunate

Antimalarial treatment

Other Names:

Pyramax

Outcome Measures

Primary Outcome Measures

Evaluation and identification of hepatic safety events, including raised liver function tests [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.

Secondary Outcome Measures

Overall safety [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 [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

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months and Older

Sexes Eligible for Study:

All

Accepts 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.

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	The Biotechnology Center Nkolbisson, Univ of Yaounde I, Messa	Yaoundé	Cameroon
2	Centre de Recherche du Centre Hospitalier du Mont Amba	Kinshasa	Congo, The Democratic Republic of the	XI
3	Centre de Santé FCRM, Hospital of Talangai	Brazzaville	Congo
4	Institut Pierre Richet / Institut National de SanPublique (IPR/INSP)	Bouaké	Côte D'Ivoire	BP 1500
5	CERMEL, Albert Schweitzer Hospital	Lambaréné	Gabon	BP 118