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OpenTrials
Completed

NCT Number: NCT02005146

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

Define the patients who lost HBsAg, studying the loss predictive factors and if there was suspension of treatment, study the evolution after that

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Key information

Conditions

Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues Blood-Borne Infections Communicable Diseases DNA Virus Infections Digestive System Diseases Hepadnaviridae Infections Hepatitis Hepatitis B Hepatitis, Viral, Human Infections Liver Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Germans Trias i Pujol, Badalona, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza Progreso y Salud

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Dec 9, 2013
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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