- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT00915057
Effect of Chronic Viral Hepatitis on the Pharmacokinetics of NRL972.
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.
Przegląd badań
Typ studiów
Zapisy (Oczekiwany)
Faza
- Faza 2
Kontakty i lokalizacje
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
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.
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
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Diagnostyczny
- Przydział: Nielosowe
- Model interwencyjny: Zadanie dla jednej grupy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
---|---|
Eksperymentalny: NRL972
Single 2mg intravenous dose of NRL972, administered on up to seven occasions
|
Single dose of NRL972 administered at baseline, at 3-monthly intervals during treatment for up to 12 months (or the end of treatment) and at 3 and 6 months after the end of treatment.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Ramy czasowe |
---|---|
Pharmacokinetics of NRL972
Ramy czasowe: Up to one hour post-dosing
|
Up to one hour post-dosing
|
Współpracownicy i badacze
Sponsor
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- NRL972-09/2008 (CHBC)
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