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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud ( Fundación Pública Andaluza Progreso y Salud )
ClinicalTrials.gov Identifier:
NCT02005146
First received: November 15, 2013
Last updated: April 30, 2015
Last verified: April 2015
  Purpose
Define the patients who lost HBsAg, studying the loss predictive factors and if there was suspension of treatment, study the evolution after that

Condition
Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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

Resource links provided by NLM:


Further study details as provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Epidemiological characteristics from hepatitis B patients who lost HBsAg related to treatment with nucleoside/nucleotide analogues [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    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:
  • Epidemiological characteristics in case of suspension of treatment. [ Time Frame: 15 months ] [ Designated as safety issue: No ]
    Count the diferents characteristics virological, histological, serological, and the clinical course of this patients whom must to be suspended the treatment


Enrollment: 86
Study Start Date: December 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
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)

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with chronic hepatitis B with HBsAg loss treated with nucleoside/nucleotide analogues
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02005146

Locations
Spain
Hospital Germans Trias i Pujol
Badalona, Barcelona, Spain
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Complejo Hospitalario Universitario Santiago
Santiago de Compostela, La Coruña, Spain
Hospital Severo Ochoa
Leganés, Madrid, Spain
Hospital Torrecárdenas
Almería, Spain
Hospital Clínic
Barcelona, Spain
Hospital del Mar
Barcelona, Spain
Hospital Universitario Vall d'Hebron
Barcelona, Spain
Hospital Universitario Reina Sofía
Córdoba, 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
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, Spain
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
Principal Investigator: Emilio Suárez García Hospital Universitario Virgen de Valme
Principal Investigator: Miguel Ángel Simón Marco Hospital Clínico Universitario Lozano Blesa
  More Information

Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02005146     History of Changes
Other Study ID Numbers: ESG-HEP-2013-01 
Study First Received: November 15, 2013
Last Updated: April 30, 2015
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud:
Hepatitis B
Nucleoside/nucleotide
HBsAg loss

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis B
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections

ClinicalTrials.gov processed this record on August 25, 2016