E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLT |
E.1.2 | Classification code | 10019715 |
E.1.2 | Term | Hepatic viral infections |
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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 |
STUDY OBJECTIVES: Primary study objectives of the ARNICA project are the following: -To evaluate factors influencing patients willingness to access therapeutic program for chronic hepatitis C (CHC) and -To evaluate efficacy, safety and adherence of antiviral treatment for CHC with pegylated interferon (PEG-IFN) alfa 2b plus ribavirin (RBV) in patients with active substance use dependence and/or in substitution or support therapy. |
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E.2.2 | Secondary objectives of the trial |
Tolerability and security of antiviral therapy with PEG-IFN and RBV; -Adherence to antiviral treatment; -Prevalence of HBV infection and its role in influencing antivaral therapy for CHC; -Prevalence of HIV coinfection and its impact on response to antiviral therapy for HCV; -Prevalence of HAVAb IgG; -Impact of HCVAb screening on alcohol consumption. ARNICA project has the porpouse to offer an HBV and HAV vaccination program among IDUs with CHC, without protection against these two hepatotrophic viruses. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
-age over 18 years; -HCVAb positivity (ELISA third generation test); -HCVRNA detected with a sensitive polimerase chain reaction (PCR) technique (cut-off<50UI/ml) at least in two recordings before screening; -HCV genotyping (InnoLipa); -compensated liver disease (Child-Pugh score <5, without any history of ascites, hepatic encefalopathy, bleeding from gastrointestinal tract); -willingness to avoid pregnancy during the whole study period and in the six months after last drug intake; -ability to read and sign a written informed consent to the study and willingness to adhere to the study. For patients with HIV/HCV coinfection following inclusion criteria are added: -HIVAb positivity (ELISA test and Western blot confirmation test for anti HIV-1 antibody); -CD4+ lymphocyte count over 200/mm3 in the last six months; -stability of the HIV infection in physician opinion. |
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E.4 | Principal exclusion criteria |
-Ipersensibility to interferon or ribavirin -pregnancy or breast feeding -Clinical history of cardiac failure, severe psichiatric disease, seizure, tyroid not compensated disease, any other severe chronic disease in sperimentator's opinion -Autoimmune hepatitis -decompenstaed liver failure -Hb<11g/dL in women and <12g/dL in men -Neutrophil count<1500/mmc -platelet count <90000/mmc -creatinine level<1.5 upper limit of normal range -Severe retinopathy For HIVAb+ patients: -opportunistic infection or neoplastic malignancy -concomitant antiretroviral theraoy with AZt or d4T or ddI |
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E.5 End points |
E.5.1 | Primary end point(s) |
efficacy of antiviral therapy with PEG-IFN and RBV will be evaluated as rate of Sustained Virologic Response (SVR) indicated by undetectable levels of HCVRNA [limit of detection of 50 IU/ml] 24 weeks after treatment termination. |
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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 | Yes |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
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) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 3 |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 2 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 2 |