Hepatitis C virus infected relapsed male and female patients MedDRA version: 12.1 Level: LLT Classification code 10008912 Term: Chronic hepatitis C
Conditions
Interventions
Product Name: Ammonium chloride
Product Code: KGR03
Pharmaceutical Form: Tablet
CAS Number: 12125029
Current Sponsor code: KGR03
Other descriptive name: Ammonium chloride
Concentration unit: mg millig
Sponsors
PHF SA
Eligibility
Sex/Gender
All
Inclusion criteria
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=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To collect preliminary data concerning the efficacy of ammonium chloride 500 mg tablets, in comparison with placebo, in terms of liver protection in hepatitis C virus patients, who relapsed after the previous first course of standard-of-care therapy, during the second cycle of the standard of care therapy of hepatitis C (peginterferon and ribavirin).;Secondary Objective: To collect preliminary data concerning the liver functionality of hepatitis C virus patients, who relapsed after the previous first course of standard-of-care therapy, treated with ammonium chloride 500 mg tablets in comparison with placebo during the second cycle of the standard of care therapy of hepatitis C (peginterferon and ribavirin). To evaluate the safety and tolerability of the addition of ammonium chloride 500 mg tablets to the hepatitis C standard-of-care therapy with peginterferon and ribavirin. ;Primary end point(s): Evaluation of the liver protection after treatment with ammonium chloride vs. placebo by comparing the proportion of subjects achieving ALT normalisation after 12 weeks of treatment between the test treatment and the control treatment. | — |
Countries
Greece
Outcome results
None listed