NIPH Clinical Trials Search

JAPANESE
国立保健医療科学院
JRCT ID: jRCT2061210044

Registered date:14/10/2021

A Study of JNJ-73763989, Pegylated Interferon Alpha-2a and Nucleos(t)ide Analogs in Participants With Chronic Hepatitis B Virus Infection

Basic Information

Recruitment status Complete
Health condition(s) or Problem(s) studiedHepatitis B, Chronic
Date of first enrollment12/01/2022
Target sample size102
Countries of recruitmentCanada,Japan,Spain,Japan,United Kingdom Of Great Britain,Japan,Hong Kong,Japan,Korea,Japan,Poland,Japan,Russian Federation,Japan,Thailand,Japan,Taiwan,Japan,UnitedStates OfAmerica,Japan
Study typeInterventional
Intervention(s)JNJ-73763989:JNJ-73763989 will be administered subcutaneously once every 4 weeks. PegIFN-alpha-2a:PegIFN-alpha-2a will be administered subcutaneously once weekly. Tenofovir disoproxil:Tenofovir disoproxil film-coated tablet will be administered orally once daily. TAF:TAF film-coated tablet will be administered orally once daily. ETV:ETV film-coated tablet will be administered orally once daily.

Outcome(s)

Primary OutcomePercentage of Participants with Reduction of at least 2log10 IU/ml in Hepatitis B Surface Antigen (HBsAg) Levels from Baseline at Week 24 (EOSI): Week 24:Percentage of participants with a reduction of at least 2 log10 international units per milliliters (IU/mL) in HBsAg levels from baseline at Week 24 (end of study intervention [EOSI]) will be reported.
Secondary Outcome-Percentage of Participants with Adverse Events (AEs):Up to Week 72:An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study. -Percentage of Participants with Serious Adverse Events (SAEs):Up to Week 72:A SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. -Percentage of Participants with Abnormalities in Clinical Laboratory Tests:Up to Week 72:Percentage of participants with abnormalities in clinical laboratory test (including hematology, blood biochemistry, blood coagulation, urinalysis, urine chemistry, renal biomarkers) will be reported. -Percentage of Participants with Abnormalities in 12-Lead Electrocardiograms (ECGs):Up to Week 28:Percentage of participants with abnormalities in 12- lead ECGs (heart rate, PR, QRS and QT corrected [QTc]) will be reported. -Percentage of Participants with Abnormalities in Vital Signs:Up to Week 72:Percentage of participants with abnormalities in vital signs (systolic blood pressure [SBP], diastolic blood pressure [DBP], and pulse rate) will be reported. -Percentage of Participants with Abnormalities in Ophthalmologic Examination:Week 8:Percentage of participants with abnormalities in ophthalmologic examination will be reported. -Percentage of Participants with Abnormalities in Physical Examination:Week24:Percentage of participants with abnormalities in physical examination will be reported. -Percentage of Participants Meeting the Protocol- defined NA Treatment Completion Criteria Based on the Week 24 EOSI or Follow-up (FU) Week 2 Results:Week 24 and FU Week 2:Percentage of participants meeting the protocol-defined NA treatment completion criteria based on the Week 24 (EOSI) or FU Week 2 results will be reported. -Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) Seroclearance at Follow-up (FU) Weeks 24 and 48 without Re-starting Nucleos(t)ide Analog (NA) Treatment:Follow-up Weeks 24 and 48:Percentage of participants with HBsAg seroclearance at FU Weeks 24 and 48 (after completion of all study interventions at Week 24) without re-starting NA treatment will be reported. -Percentage of Participants with Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <lower limit of quantification (LLOQ) at FU Weeks 24 and 48 Without Re-starting NA Treatment:Follow-up Weeks 24 and 48:Percentage of participants with HBV DNA <LLOQ at FU Weeks 24 and 48 (after completion of all study interventions at Week 24) without re-starting NA treatment will be reported. -Percentage of Participants with Virologic Flares:Up to Week 72:Percentage of participants with virologic flares will be reported. -Percentage of Participants with Biochemical Flares:Up to Week 72:Percentage of participants with biochemical flares will be reported. -Percentage of Participants Requiring NA Re-treatment:Up to Week 72:Percentage of participants requiring NA re-treatment based on failure in NA treatment completion criteria will be reported. -Percentage of Participants with HBsAg, Hepatitis B e Antigen (HBeAg), HBV DNA, and Alanine Aminotransferase (ALT) Levels Below/Above Different Cut-offs Over Time:Up to Week 72:Percentage of participants with HBsAg, HBeAg, HBV DNA, and ALT levels below/above different cut-offs over time will be reported. -Percentage of Participants with HBsAg Seroconversion:Up to Week 72:Percentage of participants with HBsAg seroconversion will be reported. -Change from Baseline Over Time in HBsAg:Baseline up to Week 72:Change from baseline over time in HBsAg will be reported. -Time to Achieve HBsAg Seroclearance/ Seroconversion:Up to Week 72:Time to achieve HBsAg seroclearance/ seroconversion will be reported. -Time to Achieve HBV DNA <LLOQ:Up to Week 72:Time to achieve HBV DNA <LLOQ will be reported. -Percentage of Participants with Virologic Breakthrough:Up to Week 24:Percentage of participants with virologic breakthrough will be reported. -Serum Concentration of JNJ-73763989 (JNJ-73763924 and JNJ-73763976):Days 1, 29, 85, 113, 169:Serum samples will be analyzed to determine concentrations of JNJ-73763989 (JNJ-73763924 and JNJ-73763976). -Serum Concentration of NA:Days 1, 29, 85, 113, 169:Serum samples will be analyzed to determine concentrations of NA. -Serum Concentration of PegIFN-alpha-2a:Days 1, 29, 85, 113, 169:Serum samples will be analyzed to determine concentrations of PegIFN-alpha-2a.

Key inclusion & exclusion criteria

Age minimum>= 18age old
Age maximum<= 65age old
GenderBoth
Include criteria- Medically stable based on physical examination, medical history, vital signs, and 12-lead electrocardiogram (ECG) performed at screening - Participants must have a body mass index between 18.0 and 35.0 kilograms per meter square (kg/m^2) inclusive - Participants with chronic hepatitis B who should: a) be chronic hepatitis B e antigen (HBeAg) -negative; b) be anti-HBe antibody-positive; c) be currently receiving nucleos(t)ide analog (NA) treatment for at least 2 years prior to screening; d) have serum hepatitis B virus (HBV) deoxyribonucleic acid (DNA) less than (<) 60 international unit/milliliter (IU/mL) on 2 sequential measurements at least 6 months apart; e) have alanine aminotransferase (ALT) values < 2.0x upper limit of normal (ULN) on 2 sequential measurements at least 6 months apart - Hepatitis B surface antigen (HBsAg) greater than (>) 5 IU/mL at screening - Fibroscan liver stiffness measurement less than or equal to (<=) 9.0 kilopascal (kPa) within 6 months prior to screening
Exclude criteria- History or signs of cirrhosis or portal hypertension - Evidence of hepatitis A, C, D, E virus infection, or human immunodeficiency virus (HIV) infection - Liver disease of non-HBV etiology - Clinically relevant alcohol or drug abuse within 12 months of screening - Participants who meet any of the additional exclusion criteria for pegylated interferon alpha-2a (PegIFN-alpha2a) as described in local prescribing information (example, refer to Pegasys SmPC or Pegasys USPI) per the investigator's discretion. Key exclusion criteria for PegIFN-alpha2a include: a) Participants with signs or symptoms compatible with autoimmune disorders. b) Participants with bone marrow suppression. c) Participants with hypoglycaemia, hyperglycaemia, and/or diabetes mellitus, who cannot be effectively controlled by medication. d) Participants with pre-existing ophthalmologic disorders. e) Participants with one or more of the following laboratory abnormalities: i) Absolute neutrophil count less than (<)1,500 cells/mm3 (<1,000 cells/mm3 for black or African American participants). ii) Serum creatinine >1.5x ULN. iii) Inadequately controlled thyroid function (thyroid stimulating hormone [TSH] and thyroxine [T4]). f) Participants with a history of a severe psychiatric disorder including severe depression, suicidal ideation and attempted suicide, or a current depression or other psychiatric disorder that is not adequately controlled on a stable medication regimen

Related Information

Contact

Public contact
Name Medical Information Center
Address 3-5-2 Nishikanda Chiyoda-ku Tokyo Tokyo Japan 101-0065
Telephone +81-120-183-275
E-mail DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Affiliation Janssen Pharmaceutical K.K.
Scientific contact
Name Takahiro Nakama
Address 3-5-2 Nishikanda Chiyoda-ku Tokyo Tokyo Japan 101-0065
Telephone +81-120-183-275
E-mail DL-JANJP-JCO_TL_TSG_EMP@its.jnj.com
Affiliation Janssen Pharmaceutical K.K.