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

Completed

• Conditions: Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues

• Registration Number: NCT02005146
• Lead Sponsor: Fundación Pública Andaluza Progreso y Salud

Brief Summary

Define the patients who lost HBsAg, studying the loss predictive factors and if there was suspension of treatment, study the evolution after that

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2013-11-15
• Study Start: 2013-12
• Study First Submitted QC: 2013-12-03
• Study First Posted: 2013-12-09
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-30
• Last Update Posted: 2015-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 86

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Epidemiological characteristics from hepatitis B patients who lost HBsAg related to treatment with nucleoside/nucleotide analogues	15 months	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.

Secondary Outcome Measures

Name	Time	Method
Epidemiological characteristics in case of suspension of treatment.	15 months	Count the diferents characteristics virological, histological, serological, and the clinical course of this patients whom must to be suspended the treatment

Trial Locations

Locations (22)

Hospital Universitario Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Germans Trias i Pujol; 🇪🇸 Badalona, Barcelona, Spain

Hospital Clínic; 🇪🇸 Barcelona, Spain

Hospital Severo Ochoa; 🇪🇸 Leganés, Madrid, Spain

Hospital Universitario Vall d'Hebron; 🇪🇸 Barcelona, Spain

Complejo Hospitalario Universitario Santiago; 🇪🇸 Santiago de Compostela, La Coruña, Spain

Hospital Torrecárdenas; 🇪🇸 Almería, Spain

Hospital del Mar; 🇪🇸 Barcelona, Spain

Hospital Puerta de Hierro; 🇪🇸 Madrid, Spain

Hospital Universitario Central de Asturias; 🇪🇸 Oviedo, Spain

Hospital La Fe; 🇪🇸 Valencia, Spain

Hospital Donosti; 🇪🇸 San Sebastián, Spain

Hospital de Navarra; 🇪🇸 Pamplona, Spain

Hospital Marqués de Valdecilla; 🇪🇸 Santander, Spain

Hospital Universitario Virgen de Valme; 🇪🇸 Sevilla, Spain

Hospital Universitario Virgen del Rocío; 🇪🇸 Sevilla, Spain

Hospital General Universitario de Valencia; 🇪🇸 Valencia, Spain

Hospital Virgen de la Salud; 🇪🇸 Toledo, Spain

Hospital Miguel Servet; 🇪🇸 Zaragoza, Spain

Hospital Clínico Universitario Lozano Blesa; 🇪🇸 Zaragoza, Spain

Hospital Universitario Reina Sofía; 🇪🇸 Córdoba, Spain

Hospital Universitario Virgen de la Macarena; 🇪🇸 Sevilla, Spain