A Phase 2 interventional study of Pyronaridine tetraphosphate 180mg:artesunate 60mg in Malaria,Falciparum, sponsored by Shin Poong Pharmaceutical Co. Ltd.. Status unknown at 2 sites in 2 countries. Open to participants aged 5 Years and older. Per ClinicalTrials.gov, last updated 2019-09-30.
Sponsored by Shin Poong Pharmaceutical Co. Ltd. · Phase 2, Interventional, and Treatment
This study will assess the efficacy of Pyramax administered for three-day, two-day or one day, in clearing a P. falciparum infection in asymptomatic carriers.
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This is a randomized, open-label, three-arm, out-patient study in asymptomatic individuals with P. falciparum monoinfection confirmed at baseline, who are >5 years of age and >20kg body weight. A total of 300 participants will be randomised into the study; 100 participants in each of three treatment arms.
Patients who fulfil the entry criteria (all inclusion and none of the exclusion criteria) will be recruited and randomized to receive Pyramax orally for three days, two days or one day in a randomization ratio of 1:1:1.
All participants will be followed until Day 63 (counted from day 0) and blood samples will be taken on Days 0, 1, 2, 3, 7, 14, 21, 28, 35, 42 and 63 for malaria diagnostics, parasite density and qPCR. In addition, blood samples reverse-transcriptase (RT)-PCR will be taken on Days 0, 1, 2, 3, 7 and 14.
Participants will be administered local SOC treatment if they meet any of the protocol-specific criteria of treatment failure: Early treatment failure, Late clinical failure, or Late parasitological failure up to and including Day 63, or if the participant withdraws at any time before Day 63, and is parasite positive.
455 studies on the registry are indexed under Malaria, Falciparum; 37 are open to participants now.
This study's enrollment of 300 is above the median of 126 across 376 interventional studies indexed under Malaria, Falciparum.
Browse Malaria, Falciparum studies →Shin Poong Pharmaceutical Co. Ltd. is the lead sponsor of 27 studies on the registry; 3 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
History of having received any antimalarial treatment (alone or in combination) during the following periods before screening:
Severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the participant inappropriate for entry into this study. Examples would include but not limited to:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Pyramax (pyronaridine tetraphosphate 180mg:artesunate 60mg) will be administered, once per day according to body weight for three days (Arm A)
Drug: Pyronaridine tetraphosphate 180mg:artesunate 60mg
Pyramax (pyronaridine tetraphosphate 180mg:artesunate 60mg) will be administered, once per day according to body weight for two days (Arm B)
Drug: Pyronaridine tetraphosphate 180mg:artesunate 60mg
Pyramax (pyronaridine tetraphosphate 180mg:artesunate 60mg) will be administered, once per day according to body weight for one day (Arm C)
Drug: Pyronaridine tetraphosphate 180mg:artesunate 60mg
ACT
Also known as: Pyramax
PCR-adjusted APR at Day 28 (based on slide assessment by microscopy)
To assess the efficacy of each dosing regimen PCR-adjusted Adequate parasitological response (APR) at Day 28
Time frame: Day 28
PCR-adjusted APR
To assess the efficacy of each dosing regimen PCR-adjusted APR at Day 63
Time frame: 63 days
PCR-unadjusted APR
To assess the efficacy of each dosing regimen PCR-unadjusted APR at Day 63
Time frame: 63 days
Rate of recurrent infections, recrudescence and new infections
To assess the efficacy of each dosing regimen on rate of recurrent infections, recrudescence and new infections
Time frame: 63 days
Proportion of parasite free participants
Proportion of participants who are parasite free by 4-8 hours, Day 1, Day 2 and Day 3 post first dosing
Time frame: 4 days
Gametocyte incidence
The area under the curve (AUC) up to Day 14 (post first dose) of gametocytes in participants with gametocytes at baseline, and separately in participants without gametocytes at baseline
Time frame: 14 days
Adverse Events
* Number (%) of patients and number of events with: * TEAEs, * serious TEAEs, * study drug related TEAEs, * study drug related serious TEAEs, * malaria-related TEAEs, * malaria-related serious TEAEs * Number (%) of patients with TEAEs and drug-related TEAEs by maximum severity, based on Grade 1 to Grade 5 (CTCAE V4.03) severity grading Adverse events will be coded by MedDRA primary system organ class and preferred term. * Hepatotoxicity related TEAEs o The number and percentage of patients with hepatotoxicity related TEAEs, based on the Standard MedDRA Query (SMQ) narrow search "Drug-related hepatic disorders" will be summarised and clinical biochemistry parameters
Time frame: 63 days
Clinical laboratory data - Haematology
Haemoglobin, haematocrit, erythrocytes, platelets, white blood cells, neutrophils, lymphocytes, monocytes, eosinophils, basophils will be summarised over time, as absolute values and changes from baseline with the number of observations, mean, standard deviation, median, quartiles, minimum and maximum. SI units will be used to summarise the data.
Time frame: 63 days
Clinical laboratory data - Biochemistry
Total and conjugated bilirubin will be summarised over time, as absolute values and changes from baseline with the number of observations, mean, standard deviation, median, quartiles, minimum and maximum. SI units will be used to summarise the data.
Time frame: 63 days
Clinical laboratory data - Liver Enzymes
Alanine aminotransaminase (ALT), Aspartate aminotransaminase (AST), Alkaline Phosphatase will be summarised over time, as absolute values and changes from baseline with the number of observations, mean, standard deviation, median, quartiles, minimum and maximum. IU/L units will be used to summarise the data
Time frame: 63 days
Clinical laboratory data - Liver Enzyme Elevations
The number (%) of participants with liver enzyme elevations after first drug administration as defined below will be summarised. * ALT or AST \> 3 x Upper Limit of Normal (ULN) * ALT or AST \> 5 x ULN * ALT or AST \> 8 x ULN * ALT or AST \> 3 x ULN and bilirubin \> 2 x ULN at the same time point (when conjugated bilirubin fraction is missing) * ALT or AST \> 3 x ULN and bilirubin \> 2 x ULN, together with a conjugated bilirubin fraction \>35% (Potential Hy's law cases), at the same time point
Time frame: 63 days
Vital signs - Blood pressure
Supine systolic and diastolic blood pressure (mm Hg) absolute values and changes from baseline will be summarised by time point with the number of observations, mean, standard deviation, median, minimum and maximum, and quartiles
Time frame: 63 days
Vital signs - Pulse rate
Pulse rate (bpm) absolute values and changes from baseline will be summarised by time point with the number of observations, mean, standard deviation, median, minimum and maximum, and quartiles
Time frame: 63 days
Vital signs - Temperature
Temperature (degrees Celsius) absolute values and changes from baseline will be summarised by time point with the number of observations, mean, standard deviation, median, minimum and maximum, and quartiles
Time frame: 63 days
Parasite free by qPCR quantification
To estimate the proportion of participants who are parasite free by qPCR quantification.
Time frame: 63 days
PCR-adjusted APR by qPCR
To estimate PCR-adjusted APR by qPCR.To estimate PCR-unadjusted APR by qPCR. To estimate the rate of recurrent infections, recrudescences and new infections by qPCR until Day 63 (post first dose) by KM analysis.
Time frame: 63 days
Percentage change in gametocytaemia.
In participants with positive detection of gametocytes by reverse transcriptase (RT)-PCR at baseline, to evaluate percentage reduction in gametocytaemia.
Time frame: 63 days
AUC of gametocytaemia by RT-PCR
To estimate area under the curve (AUC) up to Day 14 of gametocytaemia by RT-PCR, in participants with positive RT-PCR at baseline and separately in participants with negative RT-PCR at baseline
Time frame: 14 days
Relationship between artesunate and pyronaridine concentration and efficacy
To explore the relationship between artesunate and pyronaridine concentration and efficacy (PCR-adjusted APR at Day 28, based on slide assessment by microscopy)
Time frame: 28 days
Plan to share: Undecided
This study is status unknown, as verified in Sep 2019. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Artesunate
Shin Poong Pharmaceutical Co. Ltd. →