In-vivo diagnostic marker for liver dysfunction. MedDRA version: 9.1 Level: LLT Classification code 10009213 Term: Cirrhosis of liver
Conditions
Interventions
Product Name: NRL972 Injection
Product Code: NRL972
Pharmaceutical Form: Solution for injection
INN or Proposed INN: FLuorescein lisicol
CAS Number: 140616-46-2
Current Sponsor code: NRL972
Other desc
Sponsors
Norgine Ltd
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Chronic hepatitis B Adult, male or female, age = 18 years and 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 =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 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) 1.4 - Bilirubin > 25 ?mol/L (except in functional hyperbilirubinaemia) - Albumin 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 Lactating 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Quantification of liver function by NRL972-pharmacokinetics before, during and after standard treatment of chronic hepatitis B and C;Secondary Objective: Safety and tolerability of repeated single doses of 2 mg NRL972 before, during and after standard treatment of chronic hepatitis;Primary end point(s): Pharmacokinetics of NRL972 in terms of the C(30):C(10)-ratio, clearance (CL & CL/BW), and apparent terminal disposition half-life (t1/2) and urinary excretion of NRL972 | — |
Countries
Bulgaria
Outcome results
None listed