Study to Evaluate Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chagas Disease

• Status: Unknown status
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: All

Summary

The hypothesis is to evaluate if the treatment with Fexinidazole will lead to a better sustained clearance of the parasites at 6 months of follow-up when in comparison to placebo in patients with chronic indeterminate CD.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Drugs for Neglected Diseases

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.