Effect of Chronic Viral Hepatitis on the Pharmacokinetics of NRL972.

Exclusion Criteria

• •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