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

Fundación Hospital Universitari Vall d'Hebron - Institut de Recerca0 个研究点目标入组 240 人开始时间: 2016年11月17日最近更新: 2017年1月31日

试验速览

暂无简介。

•-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

•-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

发起方

Fundación Hospital Universitari Vall d'Hebron - Institut de Recerca