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

Phase 1

• Conditions: Hepatitis C virus infected relapsed male and female patients; MedDRA version: 12.1Level: LLTClassification code 10008912Term: Chronic hepatitis C

• Registration Number: EUCTR2009-017740-13-GR
• Lead Sponsor: PHF SA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02-16
• Last Update Posted: 10 October 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

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