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.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10065051 |
E.1.2 | Term | Acute 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 primary objective is to test if vitamin D supplementation improves the chances of standard treatment for HCV infection being effective. To test this we will measure if there is an improvement in the virologic response - ie the level of virus in the blood, 12 weeks after completion of treatment.
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E.2.2 | Secondary objectives of the trial |
• To determine the proportion of patients with rapid virological response (RVR is defined as negative viral load after only 4 weeks of therapy) • To determine the proportion of eligible patients undergoing standard therapy for HCV infection who consent to the study and the drop out rate from therapy of those who consent as compared to those who do not consent in order to establish if a larger multi centre trial to follow this one is feasible. • To determine the proportion of patients with sustained virologic response (SVR) at 24 weeks. (A SVR is defined as undetectable viral load 24 weeks after cessation of therapy). • To determine the impact on the immune system of supplementation with Vitamin D3 as measured by immune markers in the blood. • To determine the effect of supplementation with Vitamin D on adherence to standard HCV therapy. • To establish the cost effectiveness of the Vitamin D intervention modelled on treating all and treating those deficient on testing.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Have confirmed hepatitis C with positive PCR for genotype 1 or 3 • Are planned to commence on standard eradication therapy for HCV • Aged 18 or over
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E.4 | Principal exclusion criteria |
• Hepatitis C genotype other than 1 or 3 • Previous treatment with interferon/ribivarin • Contraindications to interferon / ribavirin therapy • eGFR <30 ml/min (by MDRD4 method) • Currently decompensated liver disease o Ascites, encephalopathy or variceal bleeding • History of renal calculi • Serum calcium <2.15 mmol/L or >2.60 mmol/L • History of sarcoidosis, metastatic malignancy • Hepatocellular carcinoma (current or previous) • Taking >400 units/day of vitamin D • HIV positive • Pregnancy • Breastfeeding • Of childbearing potential and not taking reliable contraception • Participation in another drug trial concurrently or within 30 days of screening for this one • Unable to provide written informed consent |
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E.5 End points |
E.5.1 | Primary end point(s) |
To determine the proportion of patients with sustained virologic response (SVR) at 12 weeks post standard therapy on Vitamin D3 as compared to placebo. |
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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) |
1) To determine the proportion of patients with rapid virological response (RVR is defined as negative HCV PCR at 4 weeks of therapy) and who therefore receive response guided shortened therapy. 2) To determine the proportion of eligible patients undergoing standard therapy for HCV infection who consent to the study and the drop out rate from therapy of those who consent as compared to those who do not consent. 3) To determine the proportion of patients with sustained virologic response (SVR) at 24 weeks. (A SVR is defined as undetectable HCV RNA 24 weeks after cessation of therapy. If this is not available a surrogate of undetectable HCV RNA at greater than 12 weeks after cessation of therapy will be used). 4). To determine the impact on the immune system of supplementation with Vitamin D3 as measured by immune markers. 5)To determine the effect of supplementation with Vitamin D3 on adherence to standard HCV therapy. 6) To establish the cost effectiveness of the Vitamin D intervention modelled on treating all and treating those deficient on testing.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
1)- 1 month 2)- 2.5 year (at study end post LPLV) 3)-12 month 4)-12 month 5)-12 month 6) - 1.5 year (at study end post LPLV) |
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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) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
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 | Yes |
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 | 5 |
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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Last visit of the last participant |
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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 | 2 |
E.8.9.1 | In the Member State concerned months | 11 |
E.8.9.1 | In the Member State concerned days | 31 |
E.8.9.2 | In all countries concerned by the trial years | 2 |
E.8.9.2 | In all countries concerned by the trial months | 11 |
E.8.9.2 | In all countries concerned by the trial days | 31 |