Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria (NCT04709692) | Clinical Trial Compass
CompletedPhase 2
Efficacy of SJ733 in Adults With Uncomplicated Plasmodium Falciparum or Vivax Malaria
Peru22 participantsStarted 2021-04-14
Plain-language summary
This Phase 2a trial recruits adult patients with uncomplicated P. vivax or P. falciparum blood-stage malaria mono-infection. The study drug SJ733 will be administered to examine its antimalarial efficacy, safety, and tolerability. This study also evaluates whether or not a fixed dose of the pharmacoenhancer cobicistat when given in combination with SJ733 significantly improves drug efficacy.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion criteria
✓. Male or female, aged 18 to 70 years of age (inclusive) at screening.
✓. Body weight between 45 kg and 90 kg inclusive
✓. Presence of mono-infection of P. falciparum or P. vivax confirmed by:
✓. Fever, as defined by axillary temperature ≥ 37.5°C or oral/rectal/tympanic temperature ≥ 38°C, or history of fever in the previous 24 hours (history of fever must be documented) and,
✓. Written informed consent provided by participant, in accordance with local practice. If the participant is unable to write, witnessed consent is permitted according to local ethical considerations.
✓. Ability to swallow oral medication.
✓. Ability and willingness to participate and to comply with the study requirements
Exclusion criteria
✕. Signs and symptoms of severe/complicated malaria according to the World Health Organization Criteria 2010 (Attachment 1: Definition of Severe Malaria)
✕. Mixed Plasmodium infection.
✕. Severe vomiting, defined as more than three times in the 24 hours prior to inclusion in the study, or severe diarrhea defined as 3 or more watery stools per day.
✕
What they're measuring
1
Crude Adequate Clinical and Parasitological Response (ACPR)
Timeframe: 14 days for each arm
2
Percent of Patients With Treatment Related Adverse Events
Timeframe: 42 days for each arm
3
Percent of Patients With Clinically Significant Abnormal Laboratory Values
Timeframe: 42 days for each arm
4
Percent of Patients With Clinically Significant Abnormal Vital Signs
Timeframe: 42 days for each arm
5
Percent of Patients With a Decrease in Hemoglobin (HB) > 2 g/dL From Baseline to an Absolute Value of < 5 g/dL
Timeframe: 42 days
6
Percent of Patients With an Absolute Neutrophil Count < 1,000/μL After Baseline
Timeframe: 42 days
7
Percent of Patients Meeting Hy's Law Criteria
Timeframe: 42 days
8
Percent of Patients With Any ALT or AST ≥ 5 x ULN
. Severe malnutrition (defined as the weight-for-height being below -3 standard deviation or less than 70% of median of the NCHS/WHO normalized reference values)
✕. Presence of a significant medical or psychiatric condition, or any other serious or chronic clinical condition requiring hospitalization, or any other condition that in the opinion of the investigator precludes participation in the study.
✕. Female patients must not be either lactating or pregnant as demonstrated by a negative serum point-of-care pregnancy test pre-dose (the result of the pre-dose assessment must be confirmed negative prior to dosing).
✕. Employment under the direct supervision of the investigators or study staff.
✕. Clinically significant alterations to hematologic or clinical chemistry parameters that in the opinion of the investigator precludes participation in the study, including:
9
Percent of Patients With a ny AST or ALT ≥ 3 x ULN Together With the Appearance of Fatigue, Nausea, Vomiting, Right Upper Quadrant Pain or Tenderness, Fever, Rash and/or Eosinophilia
Timeframe: 42 days
10
Percent of Patients With Persistent ALT ≥ 3 x ULN for a Period of More Than 4 Weeks.
Timeframe: 42 days
11
Percent of Patients With Clinical Signs of Possible Cutaneous Adverse Reactions
Timeframe: 42 days
12
Percent of Patients With Clinically Significant Increases in Venous Methemoglobin Levels
Timeframe: 42 days
13
Percent of Patients With Significant Changes in ECG Findings