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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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02005146
Recruitment Status : Completed
First Posted : December 9, 2013
Last Update Posted : May 1, 2015
Sponsor:
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud )

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

Condition or disease
Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues

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Study Type : Observational
Actual Enrollment : 86 participants
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
Study Start Date : December 2013
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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)



Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02005146


Locations
Show Show 22 study locations
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Investigators
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Principal Investigator: Emilio Suárez García Hospital Universitario Virgen de Valme
Principal Investigator: Miguel Ángel Simón Marco Hospital Clínico Universitario Lozano Blesa
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Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT02005146    
Other Study ID Numbers: ESG-HEP-2013-01
First Posted: December 9, 2013    Key Record Dates
Last Update Posted: May 1, 2015
Last Verified: April 2015
Keywords provided by Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud ):
Hepatitis B
Nucleoside/nucleotide
HBsAg loss
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis B
Hepatitis B, Chronic
Hepatitis
Hepatitis, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections