NCT00915057已完成2 期
An Open Study to Investigate the Effects of Chronic Viral Hepatitis B or C on the Pharmacokinetics of Cholyl-lysyl-fluorescein (NRL972) Before, During and After Standard Treatment.
Norgine4 个研究点 分布在 2 个国家目标入组 100 人开始时间: 2009年3月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 4
- 主要终点
- Pharmacokinetics of NRL972
研究概览
简要总结
Little is known about the nature and extent of the disturbance in hepatic function and biliary hepatic clearance in chronic viral hepatitis, while the course of this disease, the functional implications and response to treatment are difficult to predict. This study aims to assess this in patients with chronic viral hepatitis B (CHB) and chronic viral hepatitis C (CHC) who are eligible for treatment in accordance with the established consensus guidelines in the involved countries. The pharmacokinetics of NRL972 will be determined at baseline (within one month of starting treatment), at 3-monthly intervals during treatment, for up to 12 months (or at the end of treatment), and at 3 and 6 months after the end on treatment. This will provide a clearer understanding regarding the use of the pharmacokinetics of NRL972 in detecting changes in biliary clearance during and after treatment for CHB and CHC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic viral 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 within 24 months before screening visit)
- •Not having been treated for chronic viral hepatitis previously ("de novo" i.e. "naïve")
- •Eligible for treatment of chronic viral 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 viral 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 within 24 months before screening visit)
- •Not having been treated for chronic viral hepatitis previously ("de novo" i.e. "naïve")
- •Eligible for treatment of chronic viral 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 viral hepatitis C plus chronic viral hepatitis B
- •Patients with combined CHB and CHC will be managed (in terms of eligibility and standard treatment in accordance with the hepatitis type with predominant viral replication.
排除标准
- •Trial specific criteria: CHB, CHC & CHB+CHC
- •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 viral hepatitis
- •Relapse after previous treatment for chronic viral hepatitis
- •Any other known cause of liver disease other than chronic viral 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
- •Criteria specifically related to the standard treatment of chronic viral 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 10 exp9/mL
- •Granulocyte count < 1,500 10 exp9/mL
- •Lymphocyte count < 500 10 exp9/mL
- •Platelets < 75,000 10 exp9/mL
- •Prothrombin time - INR > 1.4
- •Bilirubin > 25 micromol/L (except in functional hyperbilirubinaemia)
- •Albumin < 35 g/L
- •Serum creatinine > 133 micromol/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)
- •All females
- •Positive pregnancy test
- •Lactating
- •Not using medically appropriate contraception and/or not willing to maintain such contraception during the treatment of chronic viral hepatitis and up to 6 months thereafter
研究组 & 干预措施
NRL972
Experimental
Single 2mg intravenous dose of NRL972, administered on up to seven occasions
干预措施: NRL972 (Drug)
结局指标
主要结局
Pharmacokinetics of NRL972
时间窗: Up to one hour post-dosing
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
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