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

NCT05550519 | Withdrawn Early Phase 1

• 3 other identifiers: CR109229NOPRODHPB00172021-005588-39
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Hepatitis B, Chronic

Outcome Measures

Primary Outcomes (3)

• Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance After Discontinuation of Nucleos(t)ide Analog (NA) Treatment

  Percentage of participants with HBsAg seroclearance after discontinuation of NA treatment will be reported.

  At Week 24

• Percentage of Participants with HBsAg Seroclearance After Discontinuation of NA Treatment

  Percentage of participants with HBsAg seroclearance after discontinuation of NA treatment will be reported.

  At Week 48

• Percentage of Participants with HBsAg Seroclearance After Discontinuation of NA Treatment

  Percentage of participants with HBsAg seroclearance after discontinuation of NA treatment will be reported.

  At Week 96

Secondary Outcomes (9)

• Percentage of Participants with Flares

  At Week 24, Week 48, and Week 96

• Change from Baseline Over Time in HBsAg Level

  Baseline up to 96 weeks

• Change from Baseline Over Time in HBV DNA level

  Baseline up to 96 weeks

• Time to Achieve First HBsAg Seroclearance

  Up to 96 weeks

• Percentage of Sustained Clinical Responders

  At Week 24, Week 48, and Week 96

Study Arms (1)

Discontinuation of Nucleos(t)ide (NA) Treatment

EXPERIMENTAL

Participants will receive standard of care NA treatment (Entecavir \[ETV\], Tenofovir Disoproxil Fumarate \[TDF\], Tenofovir Alafenamide \[TAF\]) in screening phase (up to 6 weeks) and in baseline visit (Day -1). NA treatment will be discontinued on Day 1 up to 96 weeks (Post-NA discontinuation off-treatment phase). Off-treatment refers to the phase after baseline, in which NA treatment will be discontinued.

Other: Entecavir (ETV); Other: Tenofovir Disoproxil Fumarate (TDF); Other: Tenofovir Alafenamide (TAF)

Interventions

Entecavir (ETV) OTHER

ETV will continue throughout screening and will be stopped at baseline.

Discontinuation of Nucleos(t)ide (NA) Treatment

Tenofovir Disoproxil Fumarate (TDF) OTHER

TDF will continue throughout screening and will be stopped at baseline.

Discontinuation of Nucleos(t)ide (NA) Treatment

Tenofovir Alafenamide (TAF) OTHER

TAF will continue throughout screening and will be stopped at baseline.

Discontinuation of Nucleos(t)ide (NA) Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Medically stable on the basis of physical examination, medical history, vital signs, and clinical laboratory tests performed at screening and during the pre-biopsy assessments. If the results of the serum chemistry panel including liver enzymes, blood coagulation, other specific tests, or hematology are outside the normal reference ranges, the participant may be included only if the investigator judges the abnormalities or deviations from normal to be not clinically significant or to be appropriate and reasonable for the population under study (in consultation with sponsor)
• Hepatitis B surface antigen (HBsAg) less than or equal to (\<=) 500 International units per milliliters (IU/mL) (and greater than \[\>\] 5 IU/mL) at screening
• Hepatitis B e antigen (HBeAg) less than (\<) lower limit of quantification and hepatitis B e antibody (HBeAb) positive at screening
• Normal liver ultrasound (at screening or within 3 months before screening \[documented evidence\])
• Participants must have a body mass index between 18.0 and 35.0 Kilograms per meter square (kg/m\^2), extremes included

You may not qualify if:

• History of or signs of cirrhosis or portal hypertension (absence of nodules, no smooth liver contour, no normal portal vein, spleen size greater than or equal to \[\>=\] 12 centimeters \[cm\]) or signs of hepatocellular carcinoma (HCC) or clinically relevant renal abnormalities on an abdominal ultrasound performed within 3 months prior to screening (based on documented evidence, if available) or at the time of screening. In case of suspicious findings on conventional ultrasound the participant may still be eligible if HCC or clinically relevant renal abnormalities have been ruled out by a more specific imaging procedure (contrast enhanced ultrasound, computed tomography \[CT\] or magnetic resonance imaging \[MRI\])
• Participant's refusal to accept blood transfusions
• Participants with clinically relevant drug or alcohol abuse within 12 months before screening
• Received an investigational intervention or used an invasive investigational medical device within 3 months before the planned enrollment or is currently enrolled in an investigational study
• Participants of Asian descent

Sponsors & Collaborators

• Janssen Pharmaceutica N.V., Belgium: lead

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

entecavir; Tenofovir; tenofovir alafenamide

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Organophosphonates; Organophosphorus Compounds; Organic Chemicals; Adenine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Janssen Pharmaceutica N.V., Belgium Clinical Trial

  Janssen Pharmaceutica N.V., Belgium

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2022
• First Posted: September 22, 2022
• Study Start: October 31, 2022
• Primary Completion: August 25, 2025
• Study Completion: August 28, 2025
• Last Updated: June 25, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share