Hepatitis B, ChronicNCT01090531
Patients With Chronic Hepatitis B and Low Viremia Not Receiving Antiviral Therapy
An observational study of Hepatitis B, Chronic, run by Johann Wolfgang Goethe University Hospital at 6 sites in Germany.
Trial summary
This observational long-term follow-up study will evaluate demographic, clinical, histological, biochemical, and virological parameters of patients with chronic hepatitis B and low viremia who do not require antiviral therapy according to current guidelines. Read more about this study
- Who is it for?
- Ages 18 to 79 years
- Conditions the study is for
- Hepatitis B, Chronic
- How many people
- 1,000 participants
- Where
- 6 sitesGermany
- Study dates
- Aug 2009to Aug 2021
- 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 to 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with chronic hepatitis B not receiving antiviral therapy
Who may be able to join
- adult patient, age 18-79
- chronic hepatitis B
- HBV-DNA < 100.000 IU/ml
- ALT ≤2 x ULN
- recent liver histology and/or FibroScan measurement
- willingness to sign informed consent
Who cannot join
- current or past antiviral therapy for hepatitis B
- chronic hepatitis B in immune tolerance phase (HBeAg positive, high viral load)
- co-infection with HIV, HCV
- malignant disease
- HCC or other liver tumor
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Germany6 sites
Charité Berlin-Campus Virchow-Klinikum
Berlin
Klinikum der J. W. Goethe-Universität
Frankfurt, 60590
Institut für Interdisziplinäre Medizin
Hamburg
Medizinische Hochschule Hannover
Hanover
Gastroenterologische Gemeinschaftspraxis Herne
Herne
Gastroenterologische Gemeinschaftspraxis Kiel
Kiel
About this study
Official title: A Multicenter, Prospective, Observational, Long-Term Follow-Up Study of Subjects With Chronic Hepatitis B and Low Viremia Who Do Not Receive Antiviral Therapy
This observational long-term follow-up study will evaluate demographic, clinical, histological, biochemical, and virological parameters of patients with chronic hepatitis B and low viremia who do not require antiviral therapy according to current guidelines. Liver stiffness values as detected by FibroScan and ARFI will also be collected if available. All data will be collected at yearly intervals (minimum). Patients included in the study are followed for up to 10 years. The target sample size is <1000.
- Conditions
- Hepatitis B, Chronic
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
Indication for Antiviral Treatment
Measured: 10 years
Development of hepatocellular carcinoma (HCC)
Measured: 10 years
Progression of Liver Fibrosis
Measured: 10 years
Secondary outcomes (5)
HBV-DNA
Measured: 10 years
Quantitative HBsAg
Measured: 10 years
Serum ALT
Measured: 10 years
Serum AFP
Measured: 10 years
FibroTest/ActiTest
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2010 (estimated)
- Study startAug 2009
- Primary completionAug 2021 (estimated)
- Study completionAug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hepatitis B, ChronicStudies 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
- Prospective
- Enrolment
- 1,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johann Wolfgang Goethe University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Georg Dultz, Johann Wolfgang Goethe University Hospital
- Investigators
- Christoph Sarrazin, MD, Principal investigator, Medizinische Klinik 1, Klinikum der J. W. Goethe-Universität Frankfurt am Main, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01090531
- Sponsor's protocol ID
- JWGUHMED1-002
- Status last verified
- Apr 2020
- First submitted
- 19 Mar 2010
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Basic M, Thiyagarajah K, Glitscher M, Schollmeier A, Wu Q, Gorgulu E, Lembeck P, Sonnenberg J, Dietz J, Finkelmeier F, Praktiknjo M, Trebicka J, Zeuzem S, Sarrazin C, Hildt E, Peiffer KH. Impaired HBsAg release and antiproliferative/antioxidant cell regulation by HBeAg-negative patient isolates reflects an evolutionary process. Liver Int. 2024 Oct;44(10):2773-2792. doi: 10.1111/liv.16048. Epub 2024 Jul 30.
PubMed 39078064
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Prospective, Observational, Long-Term Follow-Up Study of Subjects With Chronic Hepatitis B and Low Viremia Who Do Not Receive Antiviral Therapy
- ClinicalTrials.gov ID
- NCT01090531
- Acronym / sponsor ID
- JWGUHMED1-002
- Conditions
- Hepatitis B, Chronic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (actual)
- Lead sponsor
- Johann Wolfgang Goethe University HospitalUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Aug 2021 (estimated)
- Study completion
- Aug 2021 (estimated)
- First posted
- 22 Mar 2010 (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.
This observational long-term follow-up study will evaluate demographic, clinical, histological, biochemical, and virological parameters of patients with chronic hepatitis B and low viremia who do not require antiviral therapy according to current guidelines. Liver stiffness values as detected by FibroScan and ARFI will also be collected if available. All data will be collected at yearly intervals (minimum). Patients included in the study are followed for up to 10 years. The target sample size is <1000.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with chronic hepatitis B not receiving antiviral therapy
Key inclusion criteria (6 listed)
- adult patient, age 18-79
- chronic hepatitis B
- HBV-DNA < 100.000 IU/ml
- ALT ≤2 x ULN
- recent liver histology and/or FibroScan measurement
Key exclusion criteria (5 listed)
- current or past antiviral therapy for hepatitis B
- chronic hepatitis B in immune tolerance phase (HBeAg positive, high viral load)
- co-infection with HIV, HCV
- malignant disease
- HCC or other liver tumor
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
Indication for Antiviral Treatment
Time frame: 10 years
Development of hepatocellular carcinoma (HCC)
Time frame: 10 years
Progression of Liver Fibrosis
Time frame: 10 years
5 secondary outcomes
HBV-DNA
Time frame: 10 years
Quantitative HBsAg
Time frame: 10 years
Serum ALT
Time frame: 10 years
Serum AFP
Time frame: 10 years
FibroTest/ActiTest
Time frame: 10 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Derived from this study: PubMed 39078064Basic M, Thiyagarajah K, Glitscher M, Schollmeier A, Wu Q, Gorgulu E, Lembeck P, Sonnenberg J, Dietz J, Finkelmeier F, Praktiknjo M, Trebicka J, Zeuzem S, Sarrazin C, Hildt E, Peiffer KH. Impaired HBsAg release and antiproliferative/antioxidant cell regulation by HBeAg-negative patient isolates reflects an evolutionary process. Liver Int. 2024 Oct;44(10):2773-2792. doi: 10.1111/liv.16048. Epub 2024 Jul 30.
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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.
Christoph Sarrazin, MD principal investigator
Medizinische Klinik 1, Klinikum der J. W. Goethe-Universität Frankfurt am Main, Germany
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis B, Chronic, run by Johann Wolfgang Goethe University Hospital at 6 sites in Germany.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Germany. 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?
Results are not available in the source record.
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?
Indication for Antiviral Treatment (time frame: 10 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01090531, which also lists 1 linked publication.
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 22 Apr 2020.