Study to Evaluate Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chagas Disease
Chagas Disease, Trypanosomiasis, South American, South American Trypanosomiasis
About this trial
This is an interventional treatment trial for Chagas Disease focused on measuring Chagas Disease, Dosage forms, Regimens
Eligibility Criteria
Inclusion Criteria:
- Confirmed diagnosis of T. cruzi infection by Serial qualitative PCR (three samples collected over a single day, at least one of which must be positive) AND Conventional serology (a minimum of two out of three positive tests must be positive [Conventional ELISA, Recombinant Elisa or IIF)
- Women in reproductive age must have a negative serum pregnancy test at screening, must not be breastfeeding, and consistently use a highly effective contraceptive method during the entire trial.
- Normal EKG (PR ≤200 msec, QRS ≤120 msec, and QTc ≥400msec and ≤450 msec interval durations) at screening
Exclusion Criteria:
- Signs and/or symptoms of chronic cardiac and/or digestive form of CD (as per Study Manual of Operations)
- History of cardiomyopathy, heart failure or ventricular arrhythmia
- Any other acute or chronic health conditions that, in the opinion of the PI, may interfere with the efficacy and/or safety evaluation of the study drug (such as acute infections, history of HIV infection, diabetes, liver and renal disease requiring medical treatment)
Laboratory test values considered clinically significant or out of the allowable range at screening as follows:
- Total WBC must be within the normal range, with an acceptable margin of +/- 5% (3,800 - 10,500 / mm3).
- Platelets must be within the normal range up to 550,000 / mm3
- Total bilirubin must be within the normal range Transaminases (ALT and AST) must be within the normal range, with an acceptable margin of 25% above the upper limit of normality (ULN), < 1.25 x ULN.
- Creatinine must be within an acceptable margin of 10% above the ULN, <1.10 x ULN.
- Alkaline phosphatase must be within the normal range up to Grade 1 CTCAE (< 2.5 x ULN)
- GGT must be within the normal range up to 2x ULN.
- Potassium, Magnesium, Calcium must be within the normal range
- History of alcohol abuse or any other drug addiction (as specified in the Study Manual of Operations).
- Any condition that prevents the patient from taking oral medication.
- Patients with contra-indication (known hypersensitivity) to other nitroimidazoles, e.g. metronidazole.
- Any concomitant use of antimicrobial or anti-parasitic agents.
Sites / Locations
- Plataforma Atención Integral de Pacientes con Enfermedad de ChagasRecruiting
- Plataforma de Atención Integral de Pacientes con Enfermedad de ChagasRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm 6
Arm 7
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Placebo Comparator
Fexinidazole, 1800 mg, 2 weeks
Fexinidazole, 1800 mg, 4 weeks
Fexinidazole, 1800 mg, 8 weeks
Fexinidazole, 1200 mg, 2 weeks
Fexinidazole, 1200 mg, 4 weeks
Fexinidazole, 1200 mg, 8 weeks
Placebo
1800mg (High Dose) 2 weeks (HD - 2 weeks) Group: Fexinidazole, 1800 mg QD for 2 weeks, followed by placebo to complete 8 weeks (total dose: 25,2 g)
1800mg (High Dose) 4 weeks (HD - 4 weeks) Group: Fexinidazole, 1800 mg QD for 4 weeks, followed by placebo to complete 8 weeks (total dose: 50,4 g)
1800mg (High Dose) 8 weeks (HD - 8 weeks) Group: Fexinidazole, 1800 mg QD, for 8 weeks (total dose: 100,8 g)
1200mg (Dose 2 weeks) 2 weeks (LD - 2 weeks) Group: Fexinidazole, 1200 mg QD for 2 weeks, followed by placebo to complete 8 weeks (total dose: 16,8 g)
1200mg (Low Dose) 4 weeks (LD - 4 weeks) Group: Fexinidazole, 1200 mg QD for 4 weeks, followed by placebo to complete 8 weeks (total dose: 33,6 g)
1200mg (Low Dose) 8 weeks (LD - 8 weeks) Group: Fexinidazole, 1200 mg QD for 8 weeks (total dose: 67,2 g)
Placebo (8 weeks) Group: Fexinidazole matched placebo tablets QD for 8 weeks.