E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Chronic liver disease caused by the hepatitis B virus. |
|
E.1.1.1 | Medical condition in easily understood language |
Chronic liver disease caused by the hepatitis B virus. |
|
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 | 17.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10019743 |
E.1.2 | Term | Hepatitis B virus (HBV) |
E.1.2 | System Organ Class | 100000004848 |
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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 |
- Using genome-wide association study (GWAS) approach to retrospectively evaluate the association of single nucleotide polymorphisms with ≥24-week post-treatment follow-up and/or 12-week and/or 24-week on-treatment responses in subjects with
HBe-antigen positive or negative Chronic Hepatitis B (CHB), who have completed therapy with Peg-IFN ± nucleos(t)ide analogue.
- Using genome-wide association study (GWAS) approach to retrospectively evaluate the association of functional exonic markers with ≥24-week post-treatment follow-up and/or 12-
week and/or 24-week on-treatment responses in subjects with HBe-antigen positive or negative Chronic Hepatitis B (CHB), who have completed therapy with Peg-IFN ± nucleos(t)ide analogue. |
|
E.2.2 | Secondary objectives of the trial |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Previously enrolled in a Roche study and treated for CHB for at least 24 weeks with Peg-IFN ± nucleoside analogue (lamivudine or entacavir) or Peg-IFN ± nucleotide analogue (adefovir) with ≥24-week post-treatment follow-up or;
• Treated in general practice for CHB with Peg-IFN according to standard of care and in line with the current summary of product characteristics (SPC) / local labeling who have no contra-indication to Peg-IFN therapy as per the local label and have been
treated with Peg-IFN for at least 24 weeks and have ≥24-week post-treatment response available at the time of blood collection. |
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E.4 | Principal exclusion criteria |
Patients infected with HAV, HCV, or HIV
|
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E.5 End points |
E.5.1 | Primary end point(s) |
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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) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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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 | 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 | Yes |
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
| No |
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 | 3 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 17 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Austria |
Bulgaria |
China |
France |
Germany |
Greece |
Italy |
Korea, Republic of |
New Zealand |
Poland |
Portugal |
Romania |
United Kingdom |
|
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
|
The end of the study is defined as the date when the last patient, last visit (LPLV) occurs.
LPLV is expected to occur in the first quarter of 2014. |
|
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 | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 5 |
E.8.9.2 | In all countries concerned by the trial days | 0 |