E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis C virus infected relapsed male and female patients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008912 |
E.1.2 | Term | Chronic hepatitis C |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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). |
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E.2.2 | Secondary objectives of the trial |
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.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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 α-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.
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E.5 End points |
E.5.1 | 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. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 2 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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Last visit of last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |