Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues Clinical Trial
Official title:
Retrospective Observational Study to Define HBsAg Loss With or Without Seroconversion to antiHBs in Patients With Chronic Hepatitis by B Virus Treated With Nucleoside/Nucleotide Analogs
Define the patients who lost HBsAg, studying the loss predictive factors and if there was suspension of treatment, study the evolution after that
| Status | Completed |
| Enrollment | 86 |
| Est. completion date | December 2014 |
| Est. primary completion date | December 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - >18 years old - Chronic hepatitis B (HBeAg+ or HBeAg-) - HBsAg loss - Treated with nucleoside/nucleotide analogues - With or without previous interferon (IFN/PEG-IFN) - Patients with HBsAg loss after 2006 - Immunocompetent patients Exclusion Criteria: - Spontaneous HBsAg loss - HBsAg loss while treatment in monotherapy or combinated with IFN or PEG-IFN. - Patients with hepatitis delta virus (HDV) coinfection. - Patients with hepatitis C virus (HCV) coinfection. - Patients with HIV coinfection. - Patients with liver transplant. - Patients with reactivated hepatitis B virus (HBV) by immuno-suppressive treatment. |
Observational Model: Cohort, Time Perspective: Retrospective
| Country | Name | City | State |
|---|---|---|---|
| Spain | Hospital Torrecárdenas | Almería | |
| Spain | Hospital Germans Trias i Pujol | Badalona | Barcelona |
| Spain | Hospital Clínic | Barcelona | |
| Spain | Hospital del Mar | Barcelona | |
| Spain | Hospital Universitario Vall d'Hebron | Barcelona | |
| Spain | Hospital Universitario Reina Sofía | Córdoba | |
| Spain | Hospital Universitario Bellvitge | L'Hospitalet de Llobregat | Barcelona |
| Spain | Hospital Severo Ochoa | Leganés | Madrid |
| Spain | Hospital Puerta de Hierro | Madrid | |
| Spain | Hospital Universitario Central de Asturias | Oviedo | |
| Spain | Hospital de Navarra | Pamplona | |
| Spain | Hospital Donosti | San Sebastián | |
| Spain | Hospital Marqués de Valdecilla | Santander | |
| Spain | Complejo Hospitalario Universitario Santiago | Santiago de Compostela | La Coruña |
| Spain | Hospital Universitario Virgen de la Macarena | Sevilla | |
| Spain | Hospital Universitario Virgen de Valme | Sevilla | |
| Spain | Hospital Universitario Virgen del Rocío | Sevilla | |
| Spain | Hospital Virgen de la Salud | Toledo | |
| Spain | Hospital General Universitario de Valencia | Valencia | |
| Spain | Hospital La Fe | Valencia | |
| Spain | Hospital Clínico Universitario Lozano Blesa | Zaragoza | |
| Spain | Hospital Miguel Servet | Zaragoza |
| Lead Sponsor | Collaborator |
|---|---|
| Fundación Pública Andaluza Progreso y Salud |
Spain,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Epidemiological characteristics from hepatitis B patients who lost HBsAg related to treatment with nucleoside/nucleotide analogues | Study the number of diferents virological, serological, clinical, histological, biochemical characteristics from hepatitis B patients who lost HBsAg related to treatment with nucleoside/nucleotide analogues. | 15 months | No |
| Secondary | Epidemiological characteristics in case of suspension of treatment. | Count the diferents characteristics virological, histological, serological, and the clinical course of this patients whom must to be suspended the treatment | 15 months | No |