Terminator 2 Register | NCT03643172

Studies
Terminator 2 Register

NCT03643172

Sponsor

Hannover Medical School

Status

Unknown status

Last Update Posted

Feb 25, 2019Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Chronic Hepatitis B, HBeAg Negative

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2018

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 1, 2018Actual

Primary Completion Date

Jul 2020Estimated

Completion Date

Jul 2024Estimated

First Submitted Date

Jun 19, 2018

First Submission Date that Met QC Criteria

Aug 21, 2018

First Posted Date

Aug 22, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 22, 2019

Last Update Posted Date

Feb 25, 2019Actual

Name	Class
German Center for Infection Research	OTHER

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

50Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
HBsAg	HBsAg Change > 1 log 48 weeks after stopping NA	48 weeks

Secondary Outcomes

Measure	Description	Time Frame
Virological relapse	HBV DNA > 2,000 IU/ml	at every visit up to 96 weeks
Biochemical relapse	ALT > 2 x upper limit of normal	at every visit up to 96 weeks

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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.

Exclusion Criteria:

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

-

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Non-cirrhotic 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

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Markus Cornberg, MD, Prof	Contact	0049-511-532-6821		cornberg.markus@mh-hannover.de
Christoph Höner zu Siederdissen, MD	Contact			hoenerzusiederdissen.christoph@mh-hannover.de

Facility	Status	City	State	ZIP	Country	Contacts
Hannover Medical School	Recruiting	Hanover	Lower Saxony	30625	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39425534	Derived	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.

ID	Term
D006509	Hepatitis B
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections