Phase II trial for assessing different benznidazol regimens in the treatment of Chagas disease in adult patients on chronic phase . BERINECE project

Phase 1

• Conditions: Chagas Disease on chronic phase; MedDRA version: 19.0Level: LLTClassification code 10008384Term: Chagas' diseaseSystem Organ Class: 100000004862; Therapeutic area: Diseases [C] - Parasitic Diseases [C03]

• Registration Number: EUCTR2016-003789-21-ES
• Lead Sponsor: Fundación Hospital Universitari Vall d'Hebron - Institut de Recerca

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-17
• Last Update Posted: 31 January 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 240

Inclusion Criteria

-Patients = 18 years old
-Patients diagnosed of Chagas disease through 2 positive serologic tests, using different antigens.
-Detectable DNA of T.Cruzi in peripheral blood through PCR.
-Written Informed Consent
-Weight = 50 kg to =80 kg
-Patients capable to fulfill with the protocol visits and procedures and have a permanent address
-Patients must be residents of Free Areas transmission vector (Triatoma infestans). (Defined by local health programs or under the definition of PAHO / WHO
-Childbearing Woman with a negative pregnancy test in serum or urine at baseline. During the treatment phase, breastfeeding is not allow and a barrier contraceptive method has to be used.
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 200
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 40

Exclusion Criteria

-Patients treated previously with benznidazol o nifurtimox (complete or incomplete)
-Inability to do the Follow Up at the stipulated dates
-Acute or chronic health problems, that according to PI opinion can interfere in the efficacy and/or safety drug evaluation (exemple: acute infections, HIV infection, hepatic disease with liver function affected and renal disease that needs supportive treatment)
-Precedent of alcohol abuse
-Patients with Known hypersensibility to nitroimidazols, for example metronidazol
-Any concomitant use or a history of use of allopurinol, antimicrobial or anti-parasitic agents or antifungal
-Laboratory parameters out of range o clinically relevant according to investigator criteria:
oLeukocytes must be within the normal range, with an acceptable margin of +/- 5%
oPlatelets must be within the normal range up to 550,000 / mm3 or 550x109 / L
oTotal bilirubin must be within the normal range

oTransaminases (ALT and AST) should be within the normal range, with an acceptable margin of 25% above the upper limit of normal (ULN) <1.25 x ULN.
oCreatinine should be within the normal range, with an acceptable margin of 10% above the ULN, <1.10 x ULN.
oAlkaline phosphatase must be within the normal range until CTCAE Grade 1 (<2.5 x ULN)
oGGT should be within the normal range up to 2x ULN.
oFasting glucose should be within the normal range

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified