E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis C Virus infection - genotype 1. Genotype 1 is least responsive to current treatment and is the focus of this study. HCV can cause severe liver damage - this study will only recruit those with no evidence of severe disease (i.e. no cirrhosis). |
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E.1.1.1 | Medical condition in easily understood language |
Inflammation of the liver occurring as a result of infection with a virus, known as hepatitis C virus, or HCV. The virus has numerous strains, known as genotypes. |
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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 |
The primary aim of the study is to determine whether rimantadine (a drug developed and used for the treatment of Influenza A infection) has antiviral effects on hepatitis C virus (HCV). |
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E.2.2 | Secondary objectives of the trial |
Whether rimantadine has an additional therapeutic benefit when given in conjunction with standard of care therapy for HCV. Whether rimantadine has additional side effects or tolerability issues when given in conjunction with standard of care therapy for HCV. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Each patient MUST: • Have a diagnosis of HCV infection, genotype 1 • Be eligible for standard combination therapy with pegylated IFN and ribavirin • Be at least 18 but no more than 65 years of age • Have signed an informed consent indicating that the patient is aware of the infectious nature of their disease and have been informed of the procedures of the protocol, the experimental nature of the therapy, alternatives, potential benefits, side effects, risks, and discomforts • Be willing and able to comply with scheduled visits, the treatment plan, and laboratory tests • Have no contraindications to receiving rimantadine therapy |
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E.4 | Principal exclusion criteria |
No patient may: • Have dementia or altered mental status that would prohibit informed consent. • Have any condition which would deem the patient ineligible for combination therapy with pegylated IFN or ribavirin. This includes pregnancy, significant cardiac, renal or autoimmune disease, severe depression or psychosis, and previous organ transplantation • Any condition which would preclude the use of rimantadine. This comprises cirrhosis or liver failure (specific criteria for diagnosis are detailed in the research protocol), significant renal impairment, pregnancy, epilepsy or history of unexplained seizures • Have any other severe, acute, or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration or may interfere with the interpretation of study results and, in the judgment of the Chief Investigator, would make the patient inappropriate for this study. This includes the presence of end stage liver disease (i.e. cirrhosis). |
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E.5 End points |
E.5.1 | Primary end point(s) |
Rimantadine-specific alterations in HCV genomic sequence. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Sample collection will end for the patient 24 weeks after the cessation of all hepatitis C treatment (i.e. 72 weeks after commencing therapy and starting the trial). Specific genomic sequence changes identified in the blood of patients given rimantadine will then form the basis for the laboratory analysis. Laboratory based analysis will not use patient samples themselves, but instead use this information to design suitable laboratory in vitro analytical samples. |
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E.5.2 | Secondary end point(s) |
Improvment in treatment response for patients receiving IMP, defined as (compared with standard of care): reduced virus load PCR during treatment, improved sustained virological response following treatment. |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
PCR levels during treatment at weeks 1, 2, 4, 12, 24, 48. Then at 6 months post-cessation (week 72). |
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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 | No |
E.8.1.2 | Open | Yes |
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 | Yes |
E.8.2.3.1 | Comparator description |
Standard of care treatment (without IMP) |
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E.8.2.4 | Number of treatment arms in the trial | 2 |
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 | No |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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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30 days after the last visit of the last subject |
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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 | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |