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

NCT ID: NCT02005146

Last Updated: 2015-05-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

86 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-12-31

Study Completion Date

2014-12-31

Brief Summary

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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

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Conditions

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Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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Patients with chronic hepatitis B treated with nRTI

Patients with chronic hepatitis B with HBsAg loss treated with nucleoside/nucleotide analogues (Lamivudine, Adefovir, Tenofovir, Telbivudine, Entecavir, Emtricitabine)

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Pública Andaluza Progreso y Salud

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilio Suárez García

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario Virgen de Valme

Miguel Ángel Simón Marco

Role: PRINCIPAL_INVESTIGATOR

Hospital Clínico Universitario Lozano Blesa

Locations

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Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status

Hospital Universitario Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Site Status

Complejo Hospitalario Universitario Santiago

Santiago de Compostela, La Coruña, Spain

Site Status

Hospital Severo Ochoa

Leganés, Madrid, Spain

Site Status

Hospital Torrecárdenas

Almería, , Spain

Site Status

Hospital Clínic

Barcelona, , Spain

Site Status

Hospital del Mar

Barcelona, , Spain

Site Status

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario Reina Sofía

Córdoba, , Spain

Site Status

Hospital Puerta de Hierro

Madrid, , Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, , Spain

Site Status

Hospital de Navarra

Pamplona, , Spain

Site Status

Hospital Donosti

San Sebastián, , Spain

Site Status

Hospital Marqués de Valdecilla

Santander, , Spain

Site Status

Hospital Universitario Virgen de la Macarena

Seville, , Spain

Site Status

Hospital Universitario Virgen de Valme

Seville, , Spain

Site Status

Hospital Universitario Virgen del Rocío

Seville, , Spain

Site Status

Hospital Virgen de la Salud

Toledo, , Spain

Site Status

Hospital General Universitario de Valencia

Valencia, , Spain

Site Status

Hospital La Fe

Valencia, , Spain

Site Status

Hospital Clínico Universitario Lozano Blesa

Zaragoza, , Spain

Site Status

Hospital Miguel Servet

Zaragoza, , Spain

Site Status

Countries

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Spain

Other Identifiers

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ESG-HEP-2013-01

Identifier Type: -

Identifier Source: org_study_id

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