Role of Non-invasive test in detecting fibrosis in chronic hepatitis B patients - Role of Non-invasive test in detecting Fibrosis in chronic Hepatitis B

Phase 1

• Conditions: evel 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

• Registration Number: EUCTR2009-010808-28-GB
• Lead Sponsor: Kings College Hospital NHS Foundation Trust

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-03-15
• Study Completion: 2013-02-07
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

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
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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.;<br> 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 <35% of the population tested.<br><br> 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.<br> ;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.