Pilot study to evaluate the efficacy, safety and tolerability of ammonium chloride in terms of protection from hepatotoxic effect of Hep C infection and normalisation of altered liver parameters, in a 3-month treatment, during the standard of care combination therapy of relapsed chronic hepatitis C patients. - Ammonium chloride pilot study

PHF SA0 个研究点开始时间: 2010年2月16日最近更新: 2016年10月10日

适应症

试验速览

暂无简介。

•1.male and female hepatitis C virus infected patients aged 18-65 years inclusive;
•2.hepatitis C virus infected patients relapsed after a previous 3 month standard of care therapy (peginterferon and ribavirin);
•3.hepatitis C virus ribonucleic acid >600 International Units per mL ;
•4.ALT >1.5 x upper limit of normality range;
•5.absence of advanced hepatic fibrosis: i.e. APRI<2;
•6.liver stiffness <14 KPa by FibroScan®;
•7.absence of detectable hepatitis A and B surface antigens and of HIV 1/2 antibodies;
•8.ability to comprehend the full nature and purpose of the study, including possible risks and side effects; ability to co-operate with the Investigator and to comply with the requirements of the entire study;
•9.signed written informed consent prior to inclusion in the study;
•10.females of child-bearing potential following highly effective contraceptive methods according to the definition of Note 3 of ICH M3 Guideline (implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner) (25) or females of not child-bearing potential permanently sterilized or in post-menopausal status since at least 2 years.
•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
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.ascertained or presumptive hypersensitivity to the active principle and/or formulations ingredients;
•2.history of anaphylaxis to drugs or allergic reactions in general;
•3.prolonged treatment with any severely hepatotoxic drug product during the 4 weeks preceding the study;
•4.concomitant underlying disease that the Investigator deems may interfere with the aims of the study: e.g. autoimmune chronic hepatitis, haemochromatosis, Wilson’s disease and a-1 anti-trypsin deficiency, signs of decompensated liver failure, presence of either respiratory or metabolic alkalosis, liver cirrhosis defined by a Child-Pugh value >5, haemoglobinopathies like thalassaemia and sickle cell anaemia;
•5.any abnormality in physical examination, ECG or diagnostic tests, any data of medical history that the Investigator deems may interfere with the aims of the study;
•6.neutropenia (<1500 neutrophils/mm3);
•7.thrombocytopenia (=100000 platelets/ mm3);
•8.abnormal value of albumin;
•9.creatinine <50 mL/min;
•10.abnormal glucose (with the exception of underlying diabetes to mild intensity: i.e. no glycaemia =140 mg/dL);
•11.subjects likely to be non-compliant or unco-operative during the study according to the Investigator or designee’s judgement;
•12.illiterate subjects;
•13.pregnant or lactating females.

发起方

PHF SA