NCT05550519

A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment

A Prospective Study to Investigate the Relationship Between Hepatitis B Surface Antigen (HBsAg) Loss and the Dynamics in Host and Viral Markers After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment in Chronic Hepatitis B E-antigen Negative Patients With Low On-treatment HBsAg Level

• Status: Withdrawn
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Janssen Pharmaceutica N.V., Belgium · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to assess the incidence of participants who reach hepatitis B surface antigen (HBsAg) seroclearance after discontinuing nucleos(t)ide analog (NA) therapy in participants with HBsAg less than or equal to (\<=) 100 international units per milliliter (IU/mL) and participants with HBsAg greater than (\>) 100 IU/mL to \<= 500 IU/mL at baseline.

Detailed description

Hepatitis B virus (HBV) virus infects the human liver. It consists of a nucleocapsid with hepatitis B core (HBc) protein and a membranous envelope containing hepatitis B surface antigen (HBsAg). Chronic hepatitis B (CHB) virus infection may lead to liver cirrhosis and hepatocellular carcinoma (HCC). Recent guidelines (European Association for the Study of the Liver \[EASL\] guidelines, Asian Pacific Association for the Study of the Liver \[APASL\] guidelines) suggest that discontinuation of treatment with nucleos(t)ide analog (NA) (Entecavir \[ETV\], tenofovir disoproxil fumarate \[TDF\] or tenofovir alafenamide \[TAF\]) in non-cirrhotic Hepatitis B e antigen (HBeAg) negative patients after a minimum of three years of viral suppression can trigger changes in virological and immune composition resulting in achieving HBsAg seroclearance (up to 25 percent \[%\]). The study will be conducted in 3 phases: screening phase (up to 6 weeks), baseline visit (1 day), and post-NA discontinuation phase (up to 96 weeks) which refers to the phase after baseline, in which treatment will be discontinued (off treatment). Discontinuation of NA treatment is considered as study intervention in this study. Collection of core liver biopsy, fine needle aspiration (FNA), and blood samples are considered study investigations/procedures. The participants will be followed for up to 2 years post-NA treatment discontinuation. The total duration of an individual participation will be up to 102 weeks (including up to 6 weeks for screening and baseline).

Conditions

• Hepatitis B, Chronic

Interventions

Type	Name	Description
OTHER	Entecavir (ETV)	ETV will continue throughout screening and will be stopped at baseline.
OTHER	Tenofovir Disoproxil Fumarate (TDF)	TDF will continue throughout screening and will be stopped at baseline.
OTHER	Tenofovir Alafenamide (TAF)	TAF will continue throughout screening and will be stopped at baseline.

Timeline

• Start date: 2022-10-31
• Primary completion: 2025-08-25
• Completion: 2025-08-28
• First posted: 2022-09-22
• Last updated: 2025-06-25