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

April 30, 2015 updated by: Fundación Pública Andaluza Progreso y Salud
Define the patients who lost HBsAg, studying the loss predictive factors and if there was suspension of treatment, study the evolution after that

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

86

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
      • Almería, Spain
        • Hospital Torrecardenas
      • Barcelona, Spain
        • Hospital Del Mar
      • Barcelona, Spain
        • Hospital Clinic
      • Barcelona, Spain
        • Hospital Universitario Vall d'Hebron
      • Córdoba, Spain
        • Hospital Universitario Reina Sofía
      • Madrid, Spain
        • Hospital Puerta de Hierro
      • Oviedo, Spain
        • Hospital Universitario Central de Asturias
      • Pamplona, Spain
        • Hospital de Navarra
      • San Sebastián, Spain
        • Hospital Donosti
      • Santander, Spain
        • Hospital Marques de Valdecilla
      • Sevilla, Spain
        • Hospital Universitario Virgen del Rocio
      • Sevilla, Spain
        • Hospital Universitario Virgen De La Macarena
      • Sevilla, Spain
        • Hospital Universitario Virgen de Valme
      • Toledo, Spain
        • Hospital Virgen de la Salud
      • Valencia, Spain
        • Hospital la Fé
      • Valencia, Spain
        • Hospital General Universitario de Valencia
      • Zaragoza, Spain
        • Hospital Miguel Servet
      • Zaragoza, Spain
        • Hospital Clinico Universitario Lozano Blesa
    • Barcelona
      • Badalona, Barcelona, Spain
        • Hospital Germans Trias I Pujol
      • L'Hospitalet de Llobregat, Barcelona, Spain
        • Hospital Universitario Bellvitge
    • La Coruña
      • Santiago de Compostela, La Coruña, Spain
        • Complejo Hospitalario Universitario Santiago
    • Madrid
      • Leganés, Madrid, Spain
        • Hospital Severo Ochoa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with chronic hepatitis B with HBsAg loss treated with nucleoside/nucleotide analogues

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Epidemiological characteristics from hepatitis B patients who lost HBsAg related to treatment with nucleoside/nucleotide analogues
Time Frame: 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.
15 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundación Pública Andaluza Progreso y Salud

Investigators

  • Principal Investigator: Emilio Suárez García, Hospital Universitario Virgen de Valme
  • Principal Investigator: Miguel Ángel Simón Marco, Hospital Clinico Universitario Lozano Blesa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

November 15, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Estimate)

May 1, 2015

Last Update Submitted That Met QC Criteria

April 30, 2015

Last Verified

April 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ESG-HEP-2013-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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