Randomized, Observational Study of Entecavir to Assess Long-term Outcomes Associated With Nucleoside/Nucleotide Monotherapy for Patients With Chronic HBV Infection: The REALM Study

CompletadoClinicalTrials.gov

ID: NCT00388674Tipo: OBSERVATIONALInicio: 18 de dic de 2006Fin estimado: 26 de oct de 2016

Gastroenterología Enfermedades Infecciosas

Traducción no disponible, mostrando original

Resumen

The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection. For the China substudy, patients randomized to entecavir will have safety and efficacy assessments performed during the first year of the study.

Elegibilidad

Edad mínima: 16 YearsSexo: ALL

Criterios de inclusión

Chronic HBV infection
HBV nucleoside/tide-naive or -experienced
Patients who, in opinion of investigator, are appropriate for initiating or modifying their HBV therapy and who are appropriate for a treatment regimen comprised of nucleoside/tide monotherapy with either ETV or another standard of care HBV nucleoside/tide analogue
Age 16 and older or minimum age required in a given country

Criterios de exclusión

Women who are pregnant or breastfeeding
Patients who, in the opinion of the investigator, are expected to have a liver transplant-free survival of less than one year
Patients who, in the opinion of the investigator, are virologically controlled on their current treatment regimen and clinically responding to treatment, unless the regimen needs to be modified for medication intolerance
Coinfection with HIV
History of malignant neoplasm(s), including hepatocellular carcinoma (HCC) and carcinoma in situ (CIS), but excluding non-melanoma skin cancers
Patients with chronic renal insufficiency, defined as a creatinine clearance \< 50 ml/min who do not have either of the following means of dose reducing ETV:
i. an approved country-specific ETV label which includes the extended interval ETV dose modification method and/or ii. an approved country specific label for the ETV oral solution AND access to the oral solution
History of dysplastic liver nodules
Known history of allergy to nucleoside/tide analogues
Prior or current treatment with entecavir
An investigator proposed study regimen which will include only interferon-alfa
An investigator proposed study regimen of combination (two or more) HBV nucleoside/tide analogues

Intervenciones

drug

entecavir

Tablets / Oral Solution, Oral, ETV = 0.5 mg - 1 mg, once daily, Investigator/Patient decision

drug

Other anti-HBV medication

Tablets / Oral Solution, Oral, depends on chosen active comparator, depends on chosen active comparator, Investigator/Patient decision

Ubicaciones

Local Institution

Ciudad de Buenos Aires, Buenos Aires, Argentina

Local Institution

El Palomar, Buenos Aires, Argentina

Local Institution

San Salvador de Jujuy, Jujuy Province, Argentina

Local Institution

Villa Nueva, Mendoza Province, Argentina

Local Institution

Salta, Salta Province, Argentina

Local Institution

Buenos Aires, Argentina

Local Institution

Buenos Aires, Argentina

Local Institution

Neuquén, Argentina

Patrocinadores

PrincipalBristol-Myers Squibb

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