Chronic Hepatitis B Treated With Nucleoside/Nucleotide AnaloguesNCT02005146
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
An observational study of Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues, run by Fundación Pública Andaluza Progreso y Salud at 22 sites in Spain.
Trial summary
Define the patients who lost HBsAg, studying the loss predictive factors and if there was suspension of treatment, study the evolution after that Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues
- How many people
- 86 participants
- Where
- 22 sitesSpain
- Study dates
- Dec 2013to Dec 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis B with HBsAg loss treated with nucleoside/nucleotide analogues
Who may be able to join
- >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
Who cannot join
- 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.
Trial locations and contacts
22 sites in 1 country.
22 sites in 1 country
Spain22 sites
Hospital Torrecárdenas
Almería
Hospital Germans Trias i Pujol
Badalona, Barcelona
Hospital Clínic
Barcelona
Hospital del Mar
Barcelona
Hospital Universitario Vall d'Hebron
Barcelona
Hospital Universitario Reina Sofía
Córdoba
Hospital Universitario Bellvitge
L'Hospitalet de Llobregat, Barcelona
Hospital Severo Ochoa
Leganés, Madrid
Hospital Puerta de Hierro
Madrid
Hospital Universitario Central de Asturias
Oviedo
Hospital de Navarra
Pamplona
Hospital Donosti
San Sebastián
Hospital Marqués de Valdecilla
Santander
Complejo Hospitalario Universitario Santiago
Santiago de Compostela, La Coruña
Hospital Universitario Virgen de la Macarena
Seville
Hospital Universitario Virgen de Valme
Seville
Hospital Universitario Virgen del Rocío
Seville
Hospital Virgen de la Salud
Toledo
Hospital General Universitario de Valencia
Valencia
Hospital La Fe
Valencia
Hospital Clínico Universitario Lozano Blesa
Zaragoza
Hospital Miguel Servet
Zaragoza
About this study
Define the patients who lost HBsAg, studying the loss predictive factors and if there was suspension of treatment, study the evolution after that
- Keywords
- Hepatitis B, Nucleoside/nucleotide, HBsAg loss
- Medical subject headings
- Hepatitis B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epidemiological characteristics from hepatitis B patients who lost HBsAg related to treatment with nucleoside/nucleotide analogues
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.
Measured: 15 months
Secondary outcomes (1)
Epidemiological characteristics in case of suspension of treatment.
Count the diferents characteristics virological, histological, serological, and the clinical course of this patients whom must to be suspended the treatment
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startDec 2013
- Primary completionDec 2014
- Study completionDec 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B Treated With Nucleoside/Nucleotide AnaloguesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emilio Suárez García, Principal investigator, Hospital Universitario Virgen de ValmeMiguel Ángel Simón Marco, Principal investigator, Hospital Clínico Universitario Lozano Blesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02005146
- Sponsor's protocol ID
- ESG-HEP-2013-01
- Status last verified
- Apr 2015
- First submitted
- 15 Nov 2013
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02005146
- Acronym / sponsor ID
- ESG-HEP-2013-01
- Keywords
- Hepatitis B, Nucleoside/nucleotide, HBsAg loss
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Dec 2014 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Define the patients who lost HBsAg, studying the loss predictive factors and if there was suspension of treatment, study the evolution after that
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis B with HBsAg loss treated with nucleoside/nucleotide analogues
Key inclusion criteria (7 listed)
- >18 years old
- Chronic hepatitis B (HBeAg+ or HBeAg-)
- HBsAg loss
- Treated with nucleoside/nucleotide analogues
- With or without previous interferon (IFN/PEG-IFN)
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Epidemiological characteristics in case of suspension of treatment.
Time frame: 15 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
Related trials for Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues
Recruiting
Three Types of Nucleotide/Nucleoside Analogues Treatment in HBV Related ACLF
Hepatitis B, Acute-On-Chronic Liver Failure
Recruiting
Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.
Hepatitis B Virus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emilio Suárez García principal investigator
Hospital Universitario Virgen de Valme
Miguel Ángel Simón Marco principal investigator
Hospital Clínico Universitario Lozano Blesa
22 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B Treated With Nucleoside/Nucleotide Analogues, run by Fundación Pública Andaluza Progreso y Salud at 22 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 22 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Epidemiological characteristics from hepatitis B patients who lost HBsAg related to treatment with nucleoside/nucleotide analogues (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.