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

• Register: ClinicalTrials.gov
• Last refreshed on: 3 August 2015
• Main ID: NCT02498782
• Date of registration: 20/08/2014
• Prospective Registration: No
• Primary sponsor: Drugs for Neglected Diseases
• Public title: Study to Evaluate Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chagas Disease
• Scientific title: Phase 2, Randomized, Multicenter, Placebo-controlled, Safety and Efficacy Study to Evaluate Six Oral Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chronic Indeterminate Chagas Disease.
• Date of first enrolment: July 2014
• Target sample size: 140
• Recruitment status: Recruiting
• URL: https://clinicaltrials.gov/show/NCT02498782
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
• Phase: Phase 2

Countries of recruitment

Bolivia

Contacts

• Name: Faustino Torrico, MD
• Affiliation: Plataforma de Antención Integral de Pacientes con Enfermedad de Chagas, Cochabamba, Bolivia

• Name: Lourdes O Daza, MD
• Affiliation: Plataforma de Antención Integral de Pacientes con Enfermedad de Chagas, Tarija, Bolivia

• Name: Isabela Ribeiro, MD

• Name: Joaquim Gascón, MD
• Affiliation: Centro de Salud Internacional, Hospital Clínico de Barcelona

Key inclusion & exclusion 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.



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

South American Trypanosomiasis

Trypanosomiasis, South American

Chagas Disease

Disease, Chagas

Intervention(s)

Drug: Fexinidazole

Drug: Placebo

Primary Outcome(s)

Serious Adverse events [Time Frame: 7 months]

Adverse events [Time Frame: 7 months]

Parasitological cure rate (PCR) [Time Frame: 8 weeks and sustained until 6 months]

Secondary Outcome(s)

Serological response [Time Frame: week 10, 4 and 6 months]

Parasite Clearance (qualitative PCR) [Time Frame: weeks 2, 3, 4, 6, 10, and at 4 and 6 months follow-up]

Parasite load [Time Frame: weeks 2, 3, 4, 6, 10 and 4 and 6 months]

Blood culture for parasite genotyping [Time Frame: 6 months]

Secondary ID(s)

DNDi-CH-FEXI-001

Source(s) of Monetary Support

Please refer to primary and secondary sponsors