- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica 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.
Panoramica dello studio
Tipo di studio
Iscrizione (Anticipato)
Fase
- Fase 2
Contatti e Sedi
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Sperimentale: 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.
|
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Lasso di tempo |
---|---|
Pharmacokinetics of NRL972
Lasso di tempo: Up to one hour post-dosing
|
Up to one hour post-dosing
|
Collaboratori e investigatori
Sponsor
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- NRL972-09/2008 (CHBC)
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su NRL972
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NorgineCompletato
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Cairo UniversityAhmed Elgazzar HospitalCompletato