Clinical trial NCT02005146: 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
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues
Keywords: Hepatitis B
Nucleoside/nucleotide
HBsAg loss
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
First posted: 2013-12-09
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with chronic hepatitis B with HBsAg loss treated with nucleoside/nucleotide analogues

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


Eligibility criteria: 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.

Primary outcomes:
measure: Epidemiological characteristics from hepatitis B patients who lost HBsAg related to treatment with nucleoside/nucleotide analogues
timeFrame: 15 months
Secondary outcomes:
measure: Epidemiological characteristics in case of suspension of treatment.
timeFrame: 15 months
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
state: Barcelona
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitario Bellvitge
state: Barcelona
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario Santiago
state: La Coruña
city: Leganés
country: Spain
facility: Hospital Severo Ochoa
state: Madrid
city: Almería
country: Spain
facility: Hospital Torrecárdenas
city: Barcelona
country: Spain
facility: Hospital Clínic
city: Barcelona
country: Spain
facility: Hospital del Mar
city: Barcelona
country: Spain
facility: Hospital Universitario Vall d'Hebron
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Puerta de Hierro
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Pamplona
country: Spain
facility: Hospital de Navarra
city: San Sebastián
country: Spain
facility: Hospital Donosti
city: Santander
country: Spain
facility: Hospital Marqués de Valdecilla
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de la Macarena
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen de Valme
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Toledo
country: Spain
facility: Hospital Virgen de la Salud
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital La Fe
city: Zaragoza
country: Spain
facility: Hospital Clínico Universitario Lozano Blesa
city: Zaragoza
country: Spain
facility: Hospital Miguel Servet
Study officials:
affiliation: Hospital Universitario Virgen de Valme
name: Emilio Suárez García
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clínico Universitario Lozano Blesa
name: Miguel Ángel Simón Marco
role: PRINCIPAL_INVESTIGATOR
References: