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 |
To document that 8 weeks treatment with ledipasvir-sofosbuvir is effective in chronic HCV genotype 4 patients without cirrhosis. |
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E.2.2 | Secondary objectives of the trial |
To document that 8 weeks of treatment with ledipasvir-sofosbuvir is effective in chronic HCV genotyp 4 patients without cirrhosis, with and without HIV, with and without high viral load. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. ≥18 years
2. Chronic HCV genotype 4 infection according to definition mentioned below
3. F0-3 with biopsy or fibroscan result (stiffness <12.5 kPa) ≤24 months old for F0-2 and <12 months old for F3**
4. HVC viral load < 10 million IU/ml, ≤6 months old
**In case the HCV infection is <24 months old (=documented negative HCV IgG or negative HCV RNA < 24 months) and there is no HBV
infection currently active or a history of alcohol abuse, then a fibroscan is not mandatory. |
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E.4 | Principal exclusion criteria |
1. HCV viral load >10 million IU/ml
2. Fibroscan >12.5 Kpa or F4 on liver biopsy or signs of portal hypertension or liver cirrhosis on imaging **
3. Disallowed co-medication that cannot be stopped or replaced: Therefore ALL co-medication, including over-the-counter drugs should be checked for potential drug-drug interactions using the summary of product characteristics (appendix A). When in doubt about drug-drug interactions, contact the coordinating investigator.
4. eGFR < 30 ml/min
5. Previous therapy with any DAA for current HCV genotype 4 infection
**In case the HCV infection is <24 months old (=documented negative HCV IgG or negative HCV RNA < 24 months) and there is no HBV infection currently active or a history of alcohol abuse, then a fibroscan is not mandatory. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Sustained viral response 12 weeks after the end of therapy (SVR12) in on-treatment study population with HCV RNA < 10 million IU/ml at start of therapy (baseline) *
*Patients with HCV RNA <10 million IU/mL at screening but > 10 million IU/mL at baseline, should extent therapy to 12 weeks and will leave the study as soon as the baseline HCV RNA load has become available. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
SVR12 in ITT study population
SVR12 in the population with < 6 million IU/ml HCV RNA
SVR12 in the population with HCV RNA < limit of detection at week 4 of therapy
SVR12 in HIV positive population |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
All 12 weeks after therapy |
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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 | No |
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 | 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 | 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 | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
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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End of the trial is last patient visit at week 12 after the end of treatment |
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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 | 0 |
E.8.9.1 | In the Member State concerned months | 3 |
E.8.9.1 | In the Member State concerned days | |
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 | 0 |