Patients With Chronic Hepatitis B and Low Viremia Not Rec... | NCT01090531

Studies
Patients With Chronic Hepatitis B and Low Viremia Not Receiving Antiviral Therapy

NCT01090531

Sponsor

Johann Wolfgang Goethe University Hospital

Status

Unknown status

Last Update Posted

Apr 22, 2020Actual

Enrollment

1,000Actual

Phase

Not provided

Conditions

Hepatitis B, Chronic

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

Apr 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Aug 2021Estimated

Completion Date

Aug 2021Estimated

First Submitted Date

Mar 19, 2010

First Submission Date that Met QC Criteria

Mar 19, 2010

First Posted Date

Mar 22, 2010Estimated

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

Apr 20, 2020

Last Update Posted Date

Apr 22, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Georg Dultz, MD, Johann Wolfgang Goethe University HospitalPrincipal Investigator

Lead Sponsor

Johann Wolfgang Goethe University HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief 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. 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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

1,000Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Indication for Antiviral Treatment		10 years
Development of hepatocellular carcinoma (HCC)		10 years
Progression of Liver Fibrosis		10 years

Secondary Outcomes

Measure	Description	Time Frame
HBV-DNA		10 years
Quantitative HBsAg		10 years
Serum ALT

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with chronic hepatitis B not receiving antiviral therapy

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Christoph Sarrazin, MD	Medizinische Klinik 1, Klinikum der J. W. Goethe-Universität Frankfurt am Main, Germany	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Charité Berlin-Campus Virchow-Klinikum		Berlin			Germany
Klinikum der J. W. Goethe-Universität

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39078064	Derived	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.

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