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Trial record 35 of 48 for:    ( Map: Gabon )

Cohort Event Monitoring Study of Pyramax®

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03201770
Recruitment Status : Completed
First Posted : June 28, 2017
Last Update Posted : June 26, 2019
Sponsor:
Collaborator:
Medicines for Malaria Venture
Information provided by (Responsible Party):
Shin Poong Pharmaceutical Co. Ltd.

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 8572 participants
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 : June 22, 2017
Actual Primary Completion Date : April 10, 2019
Actual Study Completion Date : April 10, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Malaria

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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Months and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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Cameroon
The Biotechnology Center Nkolbisson, Univ of Yaounde I, Messa
Yaoundé, Cameroon
Congo, The Democratic Republic of the
Centre de Recherche du Centre Hospitalier du Mont Amba
Kinshasa, Congo, The Democratic Republic of the, XI
Congo
Centre de Santé FCRM, Hospital of Talangai
Brazzaville, Congo
Côte D'Ivoire
Institut Pierre Richet / Institut National de SanPublique (IPR/INSP)
Bouaké, Côte D'Ivoire, BP 1500
Gabon
CERMEL, Albert Schweitzer Hospital
Lambaréné, Gabon, BP 118
Sponsors and Collaborators
Shin Poong Pharmaceutical Co. Ltd.
Medicines for Malaria Venture
Investigators
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Principal Investigator: Michael Ramharter, MD, DTM&H CERMEL, University of Tübingen, Germany

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Responsible Party: Shin Poong Pharmaceutical Co. Ltd.
ClinicalTrials.gov Identifier: NCT03201770     History of Changes
Other Study ID Numbers: SP-C-021-15
First Posted: June 28, 2017    Key Record Dates
Last Update Posted: June 26, 2019
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shin Poong Pharmaceutical Co. Ltd.:
Uncomplicated Malaria
Pyramax
Pyronaridine artesunate
Additional relevant MeSH terms:
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Malaria
Malaria, Falciparum
Protozoan Infections
Parasitic Diseases
Artesunate
Pyronaridine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Antineoplastic Agents
Antiviral Agents
Schistosomicides
Antiplatyhelmintic Agents
Anthelmintics