Trial record 138 of 445 for:    hepatitis b | Open Studies

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 is currently recruiting participants. (see Contacts and Locations)
Verified June 2014 by Fundación Pública Andaluza Progreso y Salud
Sponsor:
Information provided by (Responsible Party):
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT02005146
First received: November 15, 2013
Last updated: June 16, 2014
Last verified: June 2014
  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 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


Estimated Enrollment: 75
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 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
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

Contacts
Contact: Emilio Suárez García 955 01 50 00
Contact: María del Mar Benjumea Vargas gestionensayosclinicos.fps@juntadeandalucia.es

Locations
Spain
Hospital Germans Trias i Pujol Not yet recruiting
Badalona, Barcelona, Spain
Contact    934 97 86 00      
Principal Investigator: Rosa María Morillas Cunill         
Principal Investigator: Ramón Planas Vila         
Hospital Universitario Bellvitge Recruiting
L'Hospitalet de Llobregat, Barcelona, Spain
Contact: Teresa Casanovas Taltavull         
Complejo Hospitalario Universitario Santiago Recruiting
Santiago de Compostela, La Coruña, Spain
Contact: Esther Molina Pérez         
Hospital Severo Ochoa Not yet recruiting
Leganés, Madrid, Spain
Contact: Francisco Gea Rodríguez         
Hospital Torrecárdenas Not yet recruiting
Almería, Spain
Contact: Marta Casado Martín         
Hospital Clínic Recruiting
Barcelona, Spain
Contact: José María Sánchez Tapias         
Hospital Universitario Vall d'Hebron Recruiting
Barcelona, Spain
Contact    934 89 30 00      
Principal Investigator: María Buti Ferret         
Principal Investigator: Rafael Esteban Mur         
Hospital del Mar Recruiting
Barcelona, Spain
Contact: Ricard Solà Lamoglia         
Hospital Universitario Reina Sofía Recruiting
Córdoba, Spain
Contact: Enrique Fraga Rivas         
Hospital Puerta de Hierro Recruiting
Madrid, Spain
Contact: José Luis Calleja Panero         
Hospital Universitario Central de Asturias Not yet recruiting
Oviedo, Spain
Contact: Manuel Rodríguez García         
Hospital de Navarra Recruiting
Pamplona, Spain
Contact: José Manuel Zozaya Urmeneta         
Hospital Donosti Recruiting
San Sebastián, Spain
Contact: Juan Ignacio Arenas Ruiz-Tapiador         
Hospital Marqués de Valdecilla Not yet recruiting
Santander, Spain
Contact: Javier Crespo García         
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain
Contact: Juan Manuel Pascasio Acevedo         
Hospital Universitario Virgen de Valme Recruiting
Sevilla, Spain
Contact: Emilio Suárez García         
Hospital Universitario Virgen de la Macarena Recruiting
Sevilla, Spain
Contact: Juan Pérez         
Hospital Virgen de la Salud Recruiting
Toledo, Spain
Contact: Rafael Gómez Rodríguez         
Hospital La Fe Recruiting
Valencia, Spain
Contact: Martín Prieto Castillo         
Hospital General Universitario de Valencia Recruiting
Valencia, Spain
Contact: Moisés Diago Madrid         
Hospital Clínico Universitario Lozano Blesa Recruiting
Zaragoza, Spain
Contact: Miguel Ángel Simón Marco         
Hospital Miguel Servet Recruiting
Zaragoza, Spain
Contact: Javier Fuentes Olmo         
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

No publications provided

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: June 16, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Fundación Pública Andaluza Progreso y Salud:
Hepatitis B
Nucleoside/nucleotide
HBsAg loss

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

ClinicalTrials.gov processed this record on July 31, 2014