Chagas disease MedDRA version: 14.0 Level: LLT Classification code 10008384 Term: Chagas' disease System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Trade Name: Radanil
Product Name: Benznidazol
Pharmaceutical Form: Tablet
INN or Proposed INN: BENZNIDAZOLE
CAS Number: 22994-85-0
Current Sponsor code: Benznidazole
Concentration unit: mg milligram(s
Sponsors
Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ?Participant willing and able to give informed consent for participation in the study ?Ability to understand study procedures and to comply with them for the entire length of the study ?Men and women, more than 20 and less than 50 years old with asymptomatic chronic Chagas disease ?No urgent need for benznidazole therapy ?Detectable T. cruzi in blood (positive qualitative PCR) ?For women of childbearing age an effective contraceptive method must be used during the treatment period and in the month following treatment Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ?Symptomatic acute or chronic Chagas disease ?Current pregnancy ?Previous therapy with benznidazole, nifurtimox or any other tripanocidal drug ?Severe hepatic or renal impairment ?Inability to give written informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To compare the evolution of the parasite load at baseline and during therapy with benznidazole and in the following 16 months after therapy, in treated and untreated patients. ? To compare the evolution of the specific immune response against T. cruzi at baseline and during therapy with benznidazole and in the following 16 months after therapy, in treated and untreated patients.;Secondary Objective: ? To evaluate and standardized molecular and immunological techniques for use in clinical practice. ? To describe the safety profile of treatment with benznidazole. ? To evaluate quantitative PCR and the specific immune response against T. cruzi as long term response surrogate markers.;Primary end point(s): The change in parasite load from baseline by quantitative PCR and the development of a specific immune response against T. cruzi analising of the frequency of T. cruzi specific T-cells secreting ?-IFN and IL-2, as well as measurements of the degree of activation of CD4 and CD8 T lymphocytes and B lymphocytes.;Timepoint(s) of evaluation of this end point: At baseline, day +15, day +60, month +5, month +11 and month +18. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Adverse events reported;Timepoint(s) of evaluation of this end point: Day +15 and day +60. | — |
Countries
Spain
Contacts
Public ContactJosé A. Pérez Molina
Fundación para la Investigación Biomédica del Hospital Ramón y Cajal
Outcome results
None listed