Chronic Hepatitis B, HBeAg NegativeNCT03643172
Terminator 2 Register
An observational study of Chronic Hepatitis B, HBeAg Negative, run by Hannover Medical School at 1 site in Germany.
Trial summary
All patients with chronic HBeAg negative hepatitis B treated with nucleos(t)ide analogues, who discontinue treatment based in the criteria outlined in the EASL hepatitis B guidelines shall be included in the present study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis B, HBeAg Negative
- How many people
- 50 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2018to Jul 2024
- 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: 1. Non-cirrhotic male and female patients with chronic hepatitis B virus infection documented by detectable HBsAg. 2. Age > 18 years 3. ongoing antiviral therapy with Entecavir or Tenofovir (TDF) 4. At least 3 years HBV-DNA < 20 IU/ml (=100 copies/ml) 5. HBeAg negative
Who may be able to join
- Male and female patients with chronic hepatitis B virus infection documented by detectable HBsAg.
- Age > 18 years
- Ongoing antiviral therapy with Entecavir or Tenofovir (TDF)
- At least 3 years HBV-DNA < 20 IU/ml (=100 copies/ml)
- HBeAg negative
- Willingness to give written informed consent and willingness to participate and to comply with the protocol.
Who cannot join
- HIV infection, persistent HDV-infection, persistent HCV infection
- History or other evidence of a medical condition associated with chronic liver disease other than HBV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- Patients with advanced liver fibrosis and liver cirrhosis (fibroscan >10.0 kPa)
- Patients with hepatocellular carcinoma
- History of major organ transplantation or other immunosuppressive conditions
Show all 9Show fewer
- History or other evidence of severe illness, malignancy or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- History of any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) 12 months prior to cessation of antiviral therapy or the expectation that such treatment will be needed at any time during the study
- -
Trial locations and contacts
1 site in 1 country.
Christoph Höner zu Siederdissen, MD contact
Germany1 site, 1 recruiting
- Recruiting
Hannover Medical School
Hanover, Lower Saxony, 30625
Markus Cornberg, MD, cornberg.markus@mh-hannover.de
Christoph Höner zu Siederdissen, MD, hoenerzusiederdissen.christoph@mh-hannover.de
About this study
Official title: Termination of Nucleos(t)Ide Analogue Therapy of HBeAg Negative Chronic Hepatitis B - 2nd Register Study
All patients with chronic HBeAg negative hepatitis B treated with nucleos(t)ide analogues, who discontinue treatment based in the criteria outlined in the EASL hepatitis B guidelines shall be included in the present study. The aim is to evaluate the clinical outcome (virological relapse, HBsAg decline) and associated virological and immunological parameters.
- Conditions
- Chronic Hepatitis B, HBeAg Negative
- Medical subject headings
- Hepatitis B, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
HBsAg
HBsAg Change > 1 log 48 weeks after stopping NA
Measured: 48 weeks
Secondary outcomes (9)
Virological relapse
HBV DNA > 2,000 IU/ml
Measured: at every visit up to 96 weeks
Biochemical relapse
ALT > 2 x upper limit of normal
Measured: at every visit up to 96 weeks
Retreatment
Retreatment until week 48 according to current EASL guidelines
Measured: at every visit up to 48 weeks
Negativity for HBsAg
HBsAg negative until week 96 of follow-up
Measured: at every visit up to 96 weeks
timepoint of relapse
timepoint of relapse
Measured: at every visit up to 96 weeks
T cell response
> 3x change of T cell responses from baseline after in vitro culture with HBV specific peptides
Measured: at every visit up to 96 weeks
Cytokine response
> 3x change of cytokines from baseline measured by ELISA and Multiplex assay
Measured: at every visit up to 96 weeks
Chance in HBcrAg
Chance in HBcrAg (U/mL)
Measured: at every visit up to 96 weeks
Change in HBV RNA
Chance in HBV RNA (U/mL)
Measured: at every visit up to 96 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2018
- Study start1 Sep 2018
- Primary completionJul 2020 (estimated)
- Study completionJul 2024 (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 Chronic Hepatitis B, HBeAg NegativeStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- German Center for Infection Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03643172
- Sponsor's protocol ID
- 2
- Status last verified
- Aug 2018
- First submitted
- 19 Jun 2018
- Last updated
- 25 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ohlendorf V, Wubbolding M, Honer Zu Siederdissen C, Bremer B, Deterding K, Wedemeyer H, Cornberg M, Maasoumy B. Limited Value of HBV-RNA for Relapse Prediction After Nucleos(t)ide Analogue Withdrawal in HBeAg-negative Hepatitis B Patients. J Viral Hepat. 2025 Apr;32(4):e14026. doi: 10.1111/jvh.14026. Epub 2024 Oct 19.
PubMed 39425534
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Termination of Nucleos(t)Ide Analogue Therapy of HBeAg Negative Chronic Hepatitis B - 2nd Register Study
- ClinicalTrials.gov ID
- NCT03643172
- Acronym / sponsor ID
- 2
- Conditions
- Chronic Hepatitis B, HBeAg Negative
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Collaborators
- German Center for Infection Research
- Study start
- 1 Sep 2018 (actual)
- Primary completion
- Jul 2020 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 22 Aug 2018 (actual)
- 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.
All patients with chronic HBeAg negative hepatitis B treated with nucleos(t)ide analogues, who discontinue treatment based in the criteria outlined in the EASL hepatitis B guidelines shall be included in the present study. The aim is to evaluate the clinical outcome (virological relapse, HBsAg decline) and associated virological and immunological parameters.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Non-cirrhotic male and female patients with chronic hepatitis B virus infection documented by detectable HBsAg. 2. Age > 18 years 3. ongoing antiviral therapy with Entecavir or Tenofovir (TDF) 4. At least 3 years HBV-DNA < 20 IU/ml (=100 copies/ml) 5. HBeAg negative
Key inclusion criteria (6 listed)
- Male and female patients with chronic hepatitis B virus infection documented by detectable HBsAg.
- Age > 18 years
- Ongoing antiviral therapy with Entecavir or Tenofovir (TDF)
- At least 3 years HBV-DNA < 20 IU/ml (=100 copies/ml)
- HBeAg negative
Key exclusion criteria (9 listed)
- HIV infection, persistent HDV-infection, persistent HCV infection
- History or other evidence of a medical condition associated with chronic liver disease other than HBV associated (e.g., hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposures).
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- Patients with advanced liver fibrosis and liver cirrhosis (fibroscan >10.0 kPa)
- Patients with hepatocellular carcinoma
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
HBsAg
Time frame: 48 weeks
HBsAg Change > 1 log 48 weeks after stopping NA
9 secondary outcomes
Virological relapse
Time frame: at every visit up to 96 weeks
Biochemical relapse
Time frame: at every visit up to 96 weeks
Retreatment
Time frame: at every visit up to 48 weeks
Negativity for HBsAg
Time frame: at every visit up to 96 weeks
timepoint of relapse
Time frame: at every visit up to 96 weeks
T cell response
Time frame: at every visit up to 96 weeks
Cytokine response
Time frame: at every visit up to 96 weeks
Chance in HBcrAg
Time frame: at every visit up to 96 weeks
Change in HBV RNA
Time frame: at every visit up to 96 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2019.
- Derived from this study: PubMed 39425534Ohlendorf V, Wubbolding M, Honer Zu Siederdissen C, Bremer B, Deterding K, Wedemeyer H, Cornberg M, Maasoumy B. Limited Value of HBV-RNA for Relapse Prediction After Nucleos(t)ide Analogue Withdrawal in HBeAg-negative Hepatitis B Patients. J Viral Hepat. 2025 Apr;32(4):e14026. doi: 10.1111/jvh.14026. Epub 2024 Oct 19.
- Individual participant dataSharing planned: No
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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 Höner zu Siederdissen, MD contact
1 site 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, HBeAg Negative, run by Hannover Medical School at 1 site 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 9 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 25 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Markus Cornberg, MD, Prof (0049-511-532-6821, cornberg.markus@mh-hannover.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBsAg (time frame: 48 weeks). 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 NCT03643172, 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 25 Feb 2019.