EUCTR2009-010808-28-GB进行中（未招募）1 期
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
Kings College Hospital NHS Foundation Trust0 个研究点目标入组 0 人开始时间: 2010年3月15日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
入选标准
- •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
排除标准
- •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.
研究者
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