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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02005146

Enrollment

Registered

2013-12-09

Start date

2013-12-31

Completion date

2014-12-31

Last updated

2015-05-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues

Keywords

Hepatitis B, Nucleoside/nucleotide, HBsAg loss

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

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Epidemiological characteristics from hepatitis B patients who lost HBsAg related to treatment with nucleoside/nucleotide analogues	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

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

Countries

Spain

Outcome results