Level of fibrosis in patients with chronic Hepatitis B(HBV). MedDRA version: 12.0 Level: LLT Classification code 10016648 Term: Fibrosis Liver MedDRA version: 12.0 Level: LLT Classification code 10008910 Term: Chronic hepatitis B
Conditions
Interventions
Product Name: 13C- labelled substrate 13C - methacetin
Product Code: 13C- labelled substrate 13C - methacetin
Pharmaceutical Form: Oral solution
INN or
Sponsors
Kings College Hospital NHS Foundation Trust
King's College London
Eligibility
Sex/Gender
All
Inclusion criteria
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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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.; Secondary Objective: 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 2) in patients with chronic hepatitis B. ;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. | — |
Countries
United Kingdom
Outcome results
None listed