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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT05550519
Other study ID # CR109229
Secondary ID 2021-005588-39NO
Status Withdrawn
Phase Early Phase 1
First received
Last updated
Start date October 31, 2022
Est. completion date August 28, 2025

Study information

Verified date October 2022
Source Janssen Pharmaceutica N.V., Belgium
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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).


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date August 28, 2025
Est. primary completion date August 25, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: - 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 Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Other:
Entecavir (ETV)
ETV will continue throughout screening and will be stopped at baseline.
Tenofovir Disoproxil Fumarate (TDF)
TDF will continue throughout screening and will be stopped at baseline.
Tenofovir Alafenamide (TAF)
TAF will continue throughout screening and will be stopped at baseline.

Locations

Country Name City State
Denmark Sygehus Lillebælt - Kolding Sygehus Kolding
Denmark Odense Universitets Hospital Odense
Denmark Sjællands University hospital Roskilde
France Hôpital Avicenne Bobigny
France CHU Grenoble La Tronche
France Hopital de La Croix Rousse Lyon
France Hopital Pontchaillou Rennes cedex 9
Germany Universitatsklinikum Frankfurt Frankfurt
Germany Medizinische Hochschule Hannover Hannover
Germany Klinikum Sankt Georg Neurologie Leipzig
Germany Universitatsklinikum Leipzig Leipzig
Germany Eberhard Karls Universität Tübingen Tübingen
Greece G.H. of Athens Evangelismos Athens
Greece Laiko General Hospital of Athens Athens
Greece General Hospital of Thessaloniki Ippokrateio Thessaloniki
Italy ASST Spedali Civili di Brescia Brescia
Italy Azienda Ospedaliero Universitaria Ospedali Riuniti di Foggia Foggia
Italy Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico Milano
Italy Azienda Ospedaliero-Universitaria di Modena, Ospedale di Baggiovara Modena
Italy Azienda Ospedaliero Universitaria Pisana Pisa
Italy Casa Sollievo della Sofferenza San Giovanni Rotondo
Italy Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino Torino
Portugal Hosp. Sra. Da Oliveira - Guimaraes Braga
Portugal Centro Hospitalar e Universitario de Coimbra Coimbra
Portugal Centro Hospitalar de Lisboa Norte - Hospital Santa Maria Lisboa
Portugal Centro Hospitalar de Trás os Montes e Alto Douro- Vila Real Vila Real
Spain Hosp. Clinic I Provincial de Barcelona Barcelona
Spain Hosp. Del Mar Barcelona
Spain Hosp. Univ. Marques de Valdecilla Santander
Spain Hosp. Clinico Univ. de Valencia València

Sponsors (1)

Lead Sponsor Collaborator
Janssen Pharmaceutica N.V., Belgium

Countries where clinical trial is conducted

Denmark,  France,  Germany,  Greece,  Italy,  Portugal,  Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 Percentage of Participants with Flares Percentage of participants with flares (virologic, biochemical, and clinical) measured by blood markers (such as HBsAg, hepatitis B virus deoxyribonucleic acid [HBV DNA], and alanine aminotransferase [ALT]) will be reported. At Week 24, Week 48, and Week 96
Secondary Change from Baseline Over Time in HBsAg Level Change from baseline over time in HBsAg level will be reported. Baseline up to 96 weeks
Secondary Change from Baseline Over Time in HBV DNA level Change from baseline over time in HBV DNA level will be reported. Baseline up to 96 weeks
Secondary Time to Achieve First HBsAg Seroclearance Time to achieve first HBsAg seroclearance will be reported. Up to 96 weeks
Secondary Percentage of Sustained Clinical Responders Percentage of sustained clinical responders (those with HBsAg seroclearance) will be reported. At Week 24, Week 48, and Week 96
Secondary Percentage of Participants with HBsAg Seroconversion Percentage of participants with HBsAg seroconversion will be reported. At Week 24, Week 48, and Week 96
Secondary Percentage of Participants with Serious Adverse Events (SAEs) SAE is any untoward medical occurrence that results in any of the following conditions that is death, life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization or results in persistent or significant disability/incapacity. Up to 96 weeks
Secondary Percentage of Participants with Abnormalities in Clinical Laboratory Parameters Percentage of participants with abnormalities in clinical laboratory parameters will be reported. Up to 96 weeks
Secondary Percentage of Participants Who Meet the NA Re-Treatment Criteria Percentage of participants who meet the NA re-treatment criteria will be reported. Up to 96 weeks
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