E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Level of fibrosis in patients with chronic Hepatitis B(HBV). |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10016648 |
E.1.2 | Term | Fibrosis Liver |
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E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10008910 |
E.1.2 | Term | Chronic hepatitis B |
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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 |
Is to validate the usefulness of non-invasive metabolic test (13C methacetin breath test) to detect significant inflammation (NI grade=/> 4) and fibrosis (scarring) (Ishak stage=/>2) in chronic Hepatitis B(HBV) patients. |
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E.2.2 | Secondary objectives of the trial |
The secondary goal of this study is to demonstrate that significant inflammation and fibrosis can be detected with a sensitivity of >80% and specificity>75% in chronic HBV patients, wherein the indeterminate breath tests results are <35% of the population tested.
To compare the outcome of metabolic (13C methacetin) breath test, fibroscan and liver biopsy in detecting significant fibrosis (Ishak stage=/>2) in patients with chronic hepatitis B.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Inclusion Criteria
1. Adult men or women (>18 years of age). 2. Patients with a confirmed diagnosis of Chronic HBV : a. Confirmed by serological testing. b. No other known co-existent liver disease, excluded by appropriate serologic testing. 3. Patients for whom a liver biopsy has been performed within the last 90 days or who will undergo a liver biopsy within the timeframe of the study.
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E.4 | Principal exclusion criteria |
Exclusion Criteria 1. Any other liver disorder including but not limited to: a. Autoimmune hepatitis b Haemochromatosis c. Wilson’s disease d. Alpha-1-antitrypsin deficiency e. Alcohol induced liver disease f. Drug induced liver disease 2. Severe congestive heart failure 3. Severe pulmonary hypertension 4. Chronic renal insufficiency defined by a serum creatinine above the limits of normal. 5. Uncontrolled diabetes mellitus 6. Any autoimmune disorder, which is currently being treated with prednisone or any other immune suppressive medication 7. Proven or suspected hepatocellular carcinoma 8. Previous surgical bypass surgery for morbid obesity 9. Extensive small bowel resection 10. Patients currently receiving total parenteral nutrition 11. Recipients of any organ transplant 12. Women who are pregnant or breastfeeding 13. Have started any kind of HBV treatment if biopsy is not on same day as of breath test. 14.Patients currently taking antibiotics, steroids or anti-fungal medications. 15. Patients who are allergic to or any other related medications. 16. Patients that based on the opinion of the investigator should not be enrolled into this study. 17. Patients unable or unwilling to sign informed consent. 18.Patient has consumed >20cc of an alcohol or have taken acetaminophen/ paracetamol in the past 24 hours prior to breath test 19.Drugs including: corticosteroids, amiodarone, tetracycline, niacin, valproic acid, methotrexate, stavudine, zidovudine. 20.History of chronic obstructive pulmonary disease or symptomatic bronchial asthma. 21.Patients that received systemic anaesthesia in the last 24 hours prior to the breath test.
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E.5 End points |
E.5.1 | Primary end point(s) |
Is to validate the usefulness of non-invasive metabolic test (13C methacetin breath test) to detect significant inflammation (NI grade=/> 4) and fibrosis (scarring) (Ishak stage=/>2) in chronic Hepatitis B(HBV) patients. |
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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 | 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 | 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 | Information not present in EudraCT |
E.8.1.2 | Open | Information not present in EudraCT |
E.8.1.3 | Single blind | Information not present in EudraCT |
E.8.1.4 | Double blind | Information not present in EudraCT |
E.8.1.5 | Parallel group | Information not present in EudraCT |
E.8.1.6 | Cross over | Information not present in EudraCT |
E.8.1.7 | Other | Information not present in EudraCT |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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 | 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 | Information not present in EudraCT |
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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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 | 6 |
E.8.9.1 | In the Member State concerned days | 0 |
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 | 6 |
E.8.9.2 | In all countries concerned by the trial days | 0 |