Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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ClinicalTrials.gov |
Last refreshed on:
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3 August 2015 |
Main ID: |
NCT02498782 |
Date of registration:
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20/08/2014 |
Prospective Registration:
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No |
Primary sponsor: |
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Public title:
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Study to Evaluate Fexinidazole Dosing Regimens for the Treatment of Adult Patients With Chagas Disease
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Scientific title:
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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:
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July 2014 |
Target sample size:
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140 |
Recruitment status: |
Recruiting |
URL:
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https://clinicaltrials.gov/show/NCT02498782 |
Study type:
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Interventional |
Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 2
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Countries of recruitment
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Bolivia
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Contacts
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Name:
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Isabela Ribeiro, MD |
Address:
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Telephone:
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+552125290400 |
Email:
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iribeiro@dndi.org |
Affiliation:
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Name:
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Lourdes O Daza, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Plataforma de Antención Integral de Pacientes con Enfermedad de Chagas, Tarija, Bolivia |
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Name:
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Faustino Torrico, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Plataforma de Antención Integral de Pacientes con Enfermedad de Chagas, Cochabamba, Bolivia |
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Name:
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Joaquim Gascón, MD |
Address:
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Telephone:
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Email:
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Affiliation:
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Centro de Salud Internacional, Hospital Clínico de Barcelona |
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Key inclusion & exclusion criteria
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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
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Health Condition(s) or Problem(s) studied
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Chagas Disease
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Disease, Chagas
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South American Trypanosomiasis
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Trypanosomiasis, South American
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Intervention(s)
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Drug: Placebo
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Drug: Fexinidazole
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Primary Outcome(s)
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Parasitological cure rate (PCR)
[Time Frame: 8 weeks and sustained until 6 months]
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Serious Adverse events
[Time Frame: 7 months]
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Adverse events
[Time Frame: 7 months]
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Secondary Outcome(s)
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Parasite Clearance (qualitative PCR)
[Time Frame: weeks 2, 3, 4, 6, 10, and at 4 and 6 months follow-up]
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Parasite load
[Time Frame: weeks 2, 3, 4, 6, 10 and 4 and 6 months]
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Blood culture for parasite genotyping
[Time Frame: 6 months]
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Serological response
[Time Frame: week 10, 4 and 6 months]
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Secondary ID(s)
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DNDi-CH-FEXI-001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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