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Cohort Event Monitoring Study of Pyramax®

Primary Purpose

Malaria,Falciparum

Status

Completed

Phase

Phase 4

Locations

International

Study Type

Interventional

Intervention

pyronaridine artesunate

About this trial

This is an interventional treatment trial for Malaria,Falciparum focused on measuring Uncomplicated Malaria, Pyramax, Pyronaridine artesunate

Eligibility Criteria

3 Months - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

The Biotechnology Center Nkolbisson, Univ of Yaounde I, Messa
Centre de Recherche du Centre Hospitalier du Mont Amba
Centre de Santé FCRM, Hospital of Talangai
Institut Pierre Richet / Institut National de SanPublique (IPR/INSP)
CERMEL, Albert Schweitzer Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Pyramax

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Overall safety

Evaluation of the adverse event reporting of Pyramax in the treatment of uncomplicated malaria under real life conditions.

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

Full Information

NCT ID

NCT03201770

First Posted

June 21, 2017

Last Updated

June 25, 2019

Sponsor

Shin Poong Pharmaceutical Co. Ltd.

Collaborators

Medicines for Malaria Venture

1. Study Identification

Unique Protocol Identification Number

NCT03201770

Brief Title

Cohort Event Monitoring Study of Pyramax®

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®

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Completed

Study Start Date

June 22, 2017 (Actual)

Primary Completion Date

April 10, 2019 (Actual)

Study Completion Date

April 10, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shin Poong Pharmaceutical Co. Ltd.

Collaborators

Medicines for Malaria Venture

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. 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).

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Malaria,Falciparum

Keywords

Uncomplicated Malaria, Pyramax, Pyronaridine artesunate

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8572 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Pyramax

Arm Type

Experimental

Arm Description

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

Intervention Type

Drug

Intervention Name(s)

pyronaridine artesunate

Other Intervention Name(s)

Pyramax

Intervention Description

Antimalarial treatment

Primary Outcome Measure Information:

Title

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

Description

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.

Secondary Outcome Measure Information:

Title

Overall safety

Description

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.

Title

Evaluation of Efficacy

Description

Time Frame

Assessment up to Day 28.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

3 Months

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael Ramharter, MD, DTM&H

Organizational Affiliation

CERMEL, University of Tübingen, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

The Biotechnology Center Nkolbisson, Univ of Yaounde I, Messa

City

Yaoundé

Country

Cameroon

Facility Name

Centre de Recherche du Centre Hospitalier du Mont Amba

City

Kinshasa

ZIP/Postal Code

Country

Congo, The Democratic Republic of the

Facility Name

Centre de Santé FCRM, Hospital of Talangai

City

Brazzaville

Country

Congo

Facility Name

Institut Pierre Richet / Institut National de SanPublique (IPR/INSP)

City

Bouaké

ZIP/Postal Code

BP 1500

Country

Côte D'Ivoire

Facility Name

CERMEL, Albert Schweitzer Hospital

City

Lambaréné

ZIP/Postal Code

BP 118

Country

Gabon

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

34166393

Citation

Koehne E, Zander N, Rodi M, Held J, Hoffmann W, Zoleko-Manego R, Ramharter M, Mombo-Ngoma G, Kremsner PG, Kreidenweiss A. Evidence for in vitro and in vivo activity of the antimalarial pyronaridine against Schistosoma. PLoS Negl Trop Dis. 2021 Jun 24;15(6):e0009511. doi: 10.1371/journal.pntd.0009511. eCollection 2021 Jun. Erratum In: PLoS Negl Trop Dis. 2022 Jun 2;16(6):e0010512.

Results Reference

derived

PubMed Identifier

34129601

Citation

Tona Lutete G, Mombo-Ngoma G, Assi SB, Bigoga JD, Koukouikila-Koussounda F, Ntamabyaliro NY, Ntoumi F, Agnandji ST, Groger M, Shin J, Borghini-Fuhrer I, Arbe-Barnes S, Allen SJ, Kremsner PG, Miller R, Duparc S, Ramharter M; CANTAM study group. Pyronaridine-artesunate real-world safety, tolerability, and effectiveness in malaria patients in 5 African countries: A single-arm, open-label, cohort event monitoring study. PLoS Med. 2021 Jun 15;18(6):e1003669. doi: 10.1371/journal.pmed.1003669. eCollection 2021 Jun.

Results Reference

derived

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Cohort Event Monitoring Study of Pyramax®

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