E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
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 |
Do patients with genotype 3 hepatitis C and cirrhosis who have failed to respond to pegylated interferon and ribavirin respond to retreatment with pegylated interferon, ribavirin and telaprevir? Does pre-treatment viral phenotyping identify patients who respond to pegylated interferon, ribavirin and telaprevir? |
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E.2.2 | Secondary objectives of the trial |
What are the side effects of therapy with pegylated interferon/ribavirin and telaprevir in a cohort of patients with genotype 3 HCV and cirrhosis? |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Patients with genotype 3 HCV and advanced fibrosis - defined as a liver biopsy within 2 years showing an Ishak fibrosis score of >4 OR rdiological evidence of cirrhosis (ultrasound scan or fibroscan reading >10.6) Previous therapy with pegylated interferon and ribavirin for at least 24 weeks with undetectable HCV RNA at the end of therapy and detectable HCV RNA six months after treatment cessation Chronic genotype 3 HCV infection, RNA positivity with genotype 3 infection confirmed at a local laboratory. HBsAg negative and no clinical evidence of co-infection with HIV Platelet count >20,000 cells/mm3, Neutrophil count > 600 cells/mm3 Negative urine pregnancy test result (for females of childbearing potential) documented within the 24-hour period prior to the first dose of study drugs. Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during treatment and 6 months after treatment end • Able and willing to give informed consent and able to comply with study requirements
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E.4 | Principal exclusion criteria |
Evidence of other cause of significant liver disease – serum ferritin > 1000, biochemical evidence of Wilson’s disease, autoantibody titres in excess of 1:160 Poorly controlled diabetes that, in the investigators opinion, precludes therapy Severe retinopathy that, in the opinion of the investigator, precludes therapy Ascites Haemoglobin concentration <11 g/dL in females or <12 g/dL in males or any patient with an increased risk for anaemia (e.g., thalassemia, sickle cell anaemia, spherocytosis, history of gastrointestinal bleeding) or for whom anaemia would be medically problematic Females who are pregnant or breast-feeding History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease within the last 2 years History of immunologically mediated disease (e.g., inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis (defined as affecting >10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected), rheumatoid arthritis requiring more than intermittent nonsteroidal anti-inflammatory medications for management Other on-going serious medical condition in the opinion of the investigator that would prohibit treatment Poorly controlled thyroid dysfunction History of major organ transplantation with an existing functional graft
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E.5 End points |
E.5.1 | Primary end point(s) |
Proportion of patients treated with telaprevir who achieve a sustained virolgical response |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
24 weeks after last dose of medication |
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E.5.2 | Secondary end point(s) |
Does pre-treatment phenotyping of hepatitis C allow us to identify which patients will respond to pegylated interferon, ribavirin and telaprevir |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
28 weeks after last dose of medication |
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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 | No |
E.6.4 | Safety | No |
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) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
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 | 4 |
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 | 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
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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 | 6 |
E.8.9.1 | In the Member State concerned days | 1 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 6 |
E.8.9.2 | In all countries concerned by the trial days | 1 |