| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Chronic Hepatitis C (CHC) |
| Epatite cronica C (CHC) |
|
| E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 14.1 |
| E.1.2 | Level | PT |
| E.1.2 | Classification code | 10008912 |
| E.1.2 | Term | Chronic hepatitis C |
| E.1.2 | System Organ Class | 10021881 - Infections and infestations |
|
| 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 provide treatment or re-treatment with PEGASYS as monotherapy or in combination with COPEGUS, to patients with CHC who participated in a previous Roche or Roche partner protocol where access to treatment or re-treatment was promised or deemed appropriate following completion of the original protocol (‘donor' protocol). |
| Fornire il trattamento o ritrattamento con PEGASYS in monoterapia o in combinazione a COPEGUS ai pazienti affetti da CHC che hanno partecipato ad un precedente protocollo di Roche o di partner Roche, dove il trattamento o il ritrattamento con PEGASYS in monoterapia o in combinazione e' stato promesso o ritenuto appropriato dopo completamento del protocollo di provenienza (protocollo 'donatore') |
|
| E.2.2 | Secondary objectives of the trial |
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
| • Be eligible for treatment or re-treatment as defined in the donor protocol; • Have completed safety and efficacy assessments as defined in the donor protocol without violation or major deviation; • Have had at least a 6 month washout period from date of last dose from donor protocol NV19865. To ensure a proper balance between risk and benefit, a longer washout period should be considered for patients who experienced lymphopenia for extended periods of time in donor protocol NV19865; • Have not received any other anti-HCV treatment after the completion of the donor protocol; • Have a negative pregnancy test (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. Additionally, fertile patients (males and females) must use two reliable forms of effective contraception(combined) during the entire period of the study (treatment and follow-up) in accordance with the locally approved label for ribavirin (COPEGUS). |
| •essere eleggibile per il trattamento o il ritrattamento come definito nel protocollo di provenienza; •avere completato le valutazioni di efficacia e di sicurezza come definite nel protocollo di provenienza senza violazioni o deviazioni; •avere avuto almeno un periodo di washout di almeno 6 mesi a partire dalla data di ultima dose del protocollo di provenienza NV19865. Per assicurare un equilibrio adeguato fra rischio e beneficio, un periodo piu' lungo di washout dovrebbe essere considerato per i pazienti che hanno manifestato la linfopenia per periodi estesi nel protocollo di provenienza NV19865; •non aver ricevuto qualunque altro trattamento anti-HCV dopo il completamento del protocollo di provenienza; •avere un test di gravidanza negativo(per le donne in eta' fertile) effettuato entro un periodo di 24 ore prima dell'assunzione della prima dose del farmaco in studio. Inoltre, i pazienti in eta' fertile (uomini e donne) devono usare due forme efficaci di contraccezione (combinate),durante l'intero periodo dello studio (trattamento e follow-up) in accordo a quanto riportato sul foglio informativo localmente approvato per la ribavirina (COPEGUS). |
|
| E.4 | Principal exclusion criteria |
| • Females who are pregnant or breast-feeding • Male partners of females who are pregnant • Patients with hemoglobinopathies • Hepatic decompensation (Child-Pugh class B and C) before or during treatment • Neutrophil counts < 1500 cells/mm3, platelet counts < 90,000 cells/mm3 or Hgb < 12 g/dL in females or < 13 g/dL in males, lymphocyte counts < 1500 cells/mm3 • Non-responder patients (defined as patients previously treated with PEGASYS and COPEGUS combination therapy at standard doses, with ≥ 80% compliance(defined as having taken ≥ 80% of PEGASYS doses, ≥ 80% of COPEGUS doses for ≥ 80% of the time between day of first dose and week 12), for at least 12 weeks and did not achieve at least a 2 log drop from their baseline viral load) History of: • Severe neuropsychiatric disease, especially depression • Significant or unstable cardiac disease • Inadequately controlled hypothyroidism or hyperthyroidism • Inadequately controlled hyperglycemia, hypoglycemia or diabetes mellitus • Immunologically mediated disease including myositis, inflammatory bowel disease,idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis, interstitial nephritis, rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management • Chronic pulmonary disease associated with functional limitation • Severe retinopathy, optic neuropathy or other serious ocular adverse event • Major organ transplantation with an existing functional graft • History or other evidence of a medical condition associated with chronic liver disease(e.g., hemochromatosis, autoimmune hepatitis, Wilson's disease, α1-antitrypsin deficiency, alcoholic liver disease, and toxin exposures) • Evidence of an active or suspected cancer or a history of malignancy where the risk of recurrence is ≥ 20% within 2 years. Patients with a lesion suspicious for hepatic malignancy on the screening imaging study will only be eligible if the likelihood of carcinoma is ≤ 10% following an appropriate evaluation. • History of any systemic anti-neoplastic or immunomodulatory treatments (including steroids given at non-physiologic doses and radiation) • History or other evidence of severe illness or any other conditions (e.g., pancreatitis)which would make the patient, in the opinion of the investigator, unsuitable for the study • Evidence of alcohol and/or drug abuse • Inability or unwillingness to provide informed consent or abide by the requirements of the study. |
| •Donne in gravidanza o che stanno allattando •Partner uomini di donne in gravidanza •Pazienti con emoglobinopatia •Scompenso epatico (classe B e C Child-Pugh) prima o durante il trattamento •Conta neutrofili < 1500 cells/mm3, conta delle piastrine < 90.000 cells/mm3 o di Hgb < 12 g/dL nelle donne o negli uomini < 13 g/dL, conta linfocitaria < 1500 cells/mm3 •Pazienti non responder (definiti come pazienti precedentemente trattati con la terapia di combinazione COPEGUS e PEGASYS alle dosi standard, con una aderenza alla terapia del ≥ 80% (definita come l'aver assunto l'80% o piu' di dosi di PEGASYS, l'80% o piu' di dosi di COPEGUS per almeno l' ≥ 80% del tempo fra il giorno della prima dose e la settimana 12), per almeno 12 settimane e non hanno ottenuto una riduzione almeno 2 log della loro carica virale rispetto al basale). Storia di: • malattia neuropsichiatrica severa, particolarmente depressione • malattia cardiaca significativa o instabile • ipotiroidismo o ipertiroidismo insufficientemente controllato • iperglicemia, ipoglicemia o diabete mellito insufficientemente controllati • malattia immunologicamente mediata, compresi miosite, malattia infiammatoria intestinale, porpora trombocitopenica idiopatica, lupus eritematoso sistemico, anemia emolitica autoimmune, dermatosclerosi, psoriasi severa, nefrite interstiziale, artrite reumatoide che non puo' essere trattata con soli farmaci antiinfiammatori non steroidei somministrati al bisogno • malattia polmonare cronica associata a limitazione funzionale • retinopatia severa, neuropatia ottica o altro evento avverso oculare serio • trapianto d'organo maggiore con organo trapiantato funzionante • storia o altra evidenza di una condizione medica associata a malattia epatica cronica (e.g. emocromatosi, epatite autoimmune, malattia di Wilson, deficienza di alfa1-antitripsina, affezione epatica alcolica, esposizione a tossine • evidenza di cancro attivo o sospetto o storia di malignita' dove il rischio di ricorrenza e' > 20% entro i 2 anni. I pazienti con una lesione sospetta di malignita' epatica ad una valutazione di screening per immagini saranno eleggibili soltanto se la probabilita' di carcinoma e' <10%, seguita da appropriata valutazione • storia di trattamenti sistemici antineoplastici o immunomodulatori (compresi steroidi dati alle dosi non fisiologiche e radiazioni) • storia o altra evidenza di malattia severa o diu qualsiasi altra condizione (e.g. pancreatite) che renderebbe il paziente, secondo il parere dello sperimentatore, inadatto allo studio • evidenza di abuso di alcool e/o droghe • incapacita' o rifiuto a fornire il consenso informato o ad attenersi ai requisiti dello studio |
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| E.5 End points |
| E.5.1 | Primary end point(s) |
|
| 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 | No |
| 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) | Yes |
| E.7.4 | Therapeutic use (Phase IV) | No |
| 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.8.2.4 | Number of treatment arms in the trial | 1 |
| 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 | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 26 |
| 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 | No |
| 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
|
| Il termine dello studio coincide con l'ultima visita dell'ultimo paziente arruolato o la data in cui sono raccolti gli ultimi dati riguardanti l'ultimo paziente, necessari per l'esecuzione dell'analisi statistica, qualunque si verifichi per ultima. |
|
| E.8.9 Initial estimate of the duration of the trial |
| E.8.9.1 | In the Member State concerned years | 0 |
| E.8.9.1 | In the Member State concerned months | 18 |
| 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 | 18 |
| E.8.9.2 | In all countries concerned by the trial days | 0 |
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