Terminator 2 Register

NCT ID: NCT03643172

Last Updated: 2019-02-25

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 50 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-09-01
• Study Completion Date: 2024-07-31

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.

Conditions

Chronic Hepatitis B, HBeAg Negative

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

1. 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

6. Willingness to give written informed consent and willingness to participate and to comply with the protocol.

Exclusion Criteria

1. HIV infection, persistent HDV-infection, persistent HCV infection

2. 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).

3. History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease

4. Patients with advanced liver fibrosis and liver cirrhosis (fibroscan >10.0 kPa)

5. Patients with hepatocellular carcinoma

6. History of major organ transplantation or other immunosuppressive conditions

7. 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

8. 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

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• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

German Center for Infection Research

OTHER

Sponsor Role: collaborator

Hannover Medical School

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Hannover Medical School

Hanover, Lower Saxony, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Markus Cornberg, MD, Prof

Role: CONTACT

cornberg.markus@mh-hannover.de

0049-511-532-6821

Christoph Höner zu Siederdissen, MD

Role: CONTACT

hoenerzusiederdissen.christoph@mh-hannover.de

Facility Contacts

Markus Cornberg, MD

Role: primary

cornberg.markus@mh-hannover.de

Christoph Höner zu Siederdissen, MD

Role: backup

hoenerzusiederdissen.christoph@mh-hannover.de

References

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.

Reference Type: DERIVED

PMID: 39425534 (View on PubMed)

Other Identifiers

2

Identifier Type: -

Identifier Source: org_study_id