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 sitesFebruary 16, 2010

Overview

No summary available.

Registry

who.int

Start Date

February 16, 2010

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

PHF SA

•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.

•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);