NCT03643172

Brief 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. The aim is to evaluate the clinical outcome (virological relapse, HBsAg decline) and associated virological and immunological parameters.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2018

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 19, 2018

Completed
2 months until next milestone

First Posted

Study publicly available on registry

August 22, 2018

Completed
10 days until next milestone

Study Start

First participant enrolled

September 1, 2018

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2020

Completed
4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2024

Completed
Last Updated

February 25, 2019

Status Verified

August 1, 2018

Enrollment Period

1.8 years

First QC Date

June 19, 2018

Last Update Submit

February 22, 2019

Conditions

Chronic Hepatitis B, HBeAg Negative

Outcome Measures

Primary Outcomes (1)

  • HBsAg

    HBsAg Change \> 1 log 48 weeks after stopping NA

    48 weeks

Secondary Outcomes (9)

  • Virological relapse

    at every visit up to 96 weeks

  • Biochemical relapse

    at every visit up to 96 weeks

  • Retreatment

    at every visit up to 48 weeks

  • Negativity for HBsAg

    at every visit up to 96 weeks

  • timepoint of relapse

    at every visit up to 96 weeks

  • +4 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, Lower Saxony, 30625, Germany

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39425534DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

blood samples

MeSH Terms

Conditions

Hepatitis B, Chronic

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Markus Cornberg, MD, Prof

CONTACT

0049-511-532-6821cornberg.markus@mh-hannover.de

Christoph Höner zu Siederdissen, MD

CONTACT

hoenerzusiederdissen.christoph@mh-hannover.de

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 19, 2018

First Posted

August 22, 2018

Study Start

September 1, 2018

Primary Completion

July 1, 2020

Study Completion

July 1, 2024

Last Updated

February 25, 2019

Record last verified: 2018-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)