EUCTR2008-003547-36-BG进行中（未招募）不适用
An open study to investigate the effects of chronic hepatitis B or C on the pharmacokinetics of cholyl-lysyl-fluorescein (NRL972) before, during and after standard treatment - NRL972 in chronic heptatitis
orgine Ltd0 个研究点目标入组 120 人开始时间: 2009年2月14日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- 性别
- All
入选标准
- •Chronic hepatitis B
- •Adult, male or female, age = 18 years and < 65 years
- •Body weight (BW) : 45 - 110 kg
- •Body mass index (BMI) : 18 – 30 kg.m-2
- •HBV Serology: HBsAg+ for = 6 months (at the time of application for treatment)
- •Serum ALT = 1.5 times ULN = 6 months (at the time of application for treatment)
- •Positive liver biopsy within 24 months before screening visit
- •Positive biopsy with signs of active disease (any level of activity by Knodell, METAVIR or ISHAK)
- •HBV DNA counts determined by quantitative PCR: = 20,000 IU/mL
- •ALT < 10 times ULN
- •HIV-Ab negative
- •Non-cirrhotic liver disease on histology
- •Not having been treated for chronic hepatitis previously (de novo i.e. naïve)
- •Eligible for treatment of chronic hepatitis in accordance with the national consensus guidelines pertinent to the country and site of conduct of the trial
- •Willing and able to provide informed consent
- •Chronic hepatitis C
- •Adult, male or female, age = 18 years and < 65 years
- •Body weight (BW) : 45 - 110 kg
- •Body mass index (BMI) : 18 – 30 kg.m-2
- •HCV-Ab+ for = 6 months (at the time of application for treatment)
- •HCV RNA counts > 10,000 U/L by quantitative PCR assay within the last 6 months (at the time of application for treatment)
- •Positive liver biopsy within 24 months before application for treatment
- •Positive biopsy with signs of fibrotic disease (levels of fibrosis METAVIR = F1 or ISHAK = F2)
- •ALT < 10 times ULN
- •HIV-Ab negative
- •Non-cirrhotic liver disease (on histology histology)
- •Not having been treated for chronic hepatitis previously (de novo i.e. naïve)
- •Eligible for treatment of chronic hepatitis in accordance with the national consensus guidelines pertinent to the country and site of conduct of the trial
- •Willing and able to provide informed consent
- •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) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •A. General criteria
- •Previous participation in the trial
- •Participation in any other clinical trial within 30 days of entry to this protocol
- •Treatment with any investigational drug within 30 days of entry to this protocol
- •Non-response to previous treatment for chronic hepatitis
- •Relapse after previous treatment for chronic hepatitis
- •Any other known cause of liver disease other than chronic hepatitis B and/or C, including but not limited to hepatitis D, haemochromatosis, alpha1-antitrypsin deficiency, Wilson’s disease, autoimmune hepatitis, drug-related liver disease
- •Evidence of advanced liver disease, such as history or presence of ascites, bleeding varices, encephalopathy
- •Patients with organ transplants
- •Hypersensitivity to prospective standard treatment
- •Any relevant co-morbidity, for instance, but not limited to:
- •- Limiting uncompensated psychiatric condition (e.g. severe depression, or a history of severe psychiatric disorder)
- •- CNS trauma or seizure disorder requiring medication
- •- Significant cardiovascular dysfunction within the past 6 months (e.g. angina, congestive cardiac failure, recent myocardial infarction, severe hypertension or significant arrhythmia)
- •- Patients with an ECG showing clinically significant abnormalities
- •- Poorly controlled diabetes mellitus
- •- Patients on haemodialysis
- •Daily use of > 40 g alcohol
- •Positive alcohol test at SCR-visit
- •Evidence or suspicion of social drug abuse
- •Positive drug test at SCR-visit
- •Use of prohibited medication
- •Suspicion or evidence that the subject is not trustworthy and reliable
- •Suspicion or evidence that the subject is not able to make a free consent or to under-stand the information in this regard
- •B. Exclusion criteria related to the medicaiton used for the standard treatment of chronic hepatitis:
- •Relevant clinical laboratory test abnormalities, for instance, but not limited to:
- •- Haemoglobin (Hgb) <11 g dL–1 for women and <13 g dL–1 for men
- •- White Blood Cell count (WBC) < 3,000 109/mL
- •- Granulocyte count < 1,500 109/mL
- •- Lymphocyte count < 500 109/mL
- •- Platelets < 75,000 109/mL
- •- Prothrombin time – INR > 1.4
- •- Bilirubin > 25 ?mol/L (except in functional hyperbilirubinaemia)
- •- Albumin < 35 g/L
- •- Serum creatinine > 133 ?mol/L
- •- Fasting blood glucose > 7.4 mmol/L for non-diabetic patients
- •- HbA1c > 7% for diabetic patients
- •- Positive auto-immune antibodies
- •- TSH outside the normal range (for patients intended for interferon)
- •Relevant co-morbidity, for instance, but not limited to:
- •- Limiting uncompensated chronic pulmonary disease (e.g. chronic obstructive pulmonary disease)
- •- Any medical condition requiring, or likely to require during the course of the study, - chronic systemic administration of steroids
- •- Gout – (for patients intended for interferon)
- •- Immunologically mediated disease (e.g. inflammatory bowel disease, Crohn’s disease, ulcerative colitis, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune haemolytic anaemia, scleroderma, severe psoriasis, cryoglobulinaemia with vasculitis) – (for patients intended for interferon)
- •Patients with clinically significant retinal abnormalities – (for patients intended for interferon)
- •C. Criteria applicable to all female subjects:
- •Positive pregnancy test
- •Not using medically appropriate contraception and/or not willing to maintain such contraception during the treatment of chronic hepatitis and up to 6 months thereafter
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