E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis C virus infection |
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E.1.1.1 | Medical condition in easily understood language |
Hepatitis C virus infection |
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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 | 20.1 |
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 |
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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 |
The main objective of this study is to identify which one of three methods of treatment is the most effective in curing hepatitis C infection in people who inject drugs. The three methods we are testing are: 1. patients receiving their medication daily at their local pharmacy or needle exchange, 2. patients receiving their medication on a fortnightly basis from the needle exchange, 3. patients receiving their medication on a fortnightly basis from the needle exchange AND getting help from a psychologist to remember to take their medicine every day. |
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E.2.2 | Secondary objectives of the trial |
1. To compare how many times patients have missed a dose of medicine in each of the three groups: 1. patients receiving their medication daily at their local pharmacy or needle exchange, 2. patients receiving their medication on a fortnightly basis from the needle exchange, 3. patients receiving their medication on a fortnightly basis from the needle exchange AND getting help from a psychologist to remember to take their medicine every day. 2. To compare how many patients in each of the three groups become reinfected with hepatitis C virus after they have been cured. 3. To measure certain proteins in the blood of patients who are not cured by the medication to see whether they have become resistant to the medicine. 4. To assess the types of illicit drugs being taken by the patients and determine whether there are any interactions with the therapeutic drugs they are prescribed for their Hepatitis C. |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
• Male or Female. (Age limit 18-70) • HCV PCR confirmed active infection, genotype 1 or 3. • If female, must have negative urine test results for pregnancy during initial screening period (for trial inclusion) and be advised of limited safety data in pregnancy. • Current illicit drug use established through patient history or active injection sites. • Able to provide informed consent, agreeing to study and monitoring criteria
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E.4 | Principal exclusion criteria |
• • Aggressive or violent behaviour. • Platelet count < 75 x 10 9 /ml • Alanine transaminase > 350U/l • Inability to provide informed consent. • Clinical history or abnormal valves for albumin< 30 g/l, Bilrubin >35 umol/l ot PTR >1.5 consistent with decompensated liver failure Childs-Pugh B or C • Clinical history of primary hepatocellular carcinoma • Pregnancy or breast feeding. • Participation in a drug trial within the previous 30 days • Hepatitis B surface antigen positive • HIV infection. • Hypersensitivity to elbasvir and grazoprevir • Hypersensitivity to sofosbuvir (genotype 3 infected-participants ony) • Currently being treated with an inhibitor of organic anion transporting polypeptide 1B, e.g. rifampicin, atazanavir, daruavir, lopinavir, saquinavir, tipranavir, cobicistat or ciclosporin. • Currently being treated with inducers of cytochrome P450 3A or P-glycoprotein, such as efavirenz, phenytoin, carbamazepine, bosentan, etravirine, modafinil or St John’s Wort (Hypericum perforatum) • Currently being treated with amiodarone (Participants infected with genotype 3 HCV only)
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary outcome measure is the rate of sustained viral response at 12 weeks obtained following oral antiviral treatment of active drug users with hepatitis C in each of three groups: daily observed therapy, fortnightly pick-up or fortnightly pick-up with a psychological interview. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
12 to 24 weeks following end of treatment. For participants treated with genotype 1 (12 week treatment) this is 24 to 36 weeks after beginning treatment. For participants treated with genotype 3 (8 week treatment) this is 20 to 32 weeks after beginning treatment. |
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E.5.2 | Secondary end point(s) |
1. To demonstrate that the achieved SVR rates in HCV PWID participants with DAA treatment are similar to RCT results and therefore a cost-effective treatment 2. To assess reinfection rates in active PWIDs treated with oral DAA regimes 3. To assess resistance profiles in those who do not achieve SVR 4. To assess the types of illicit drugs taken by trial participants and identify any interaction with the DAAs |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1. Adherence calculated at end of treatment (daily logs and counting tablets) 2. Hepatitis C viral loads measure annually at clinic visits 3. Profiles of the HCV viral resistance proteins, NS5a and NS3 from blood collected at baseline, end of treatment and SVR12 4. Urine toxicology at end of treatment |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
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) | 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 | 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 | 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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End of trial is defined as the date of database lock. This will enable data cleaning and verification to be carried out prior to end of trial and is the recommended end of trial point by the sponsor. |
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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 | 1 |
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 | 1 |