A Study of JNJ-73763989 + Nucleos(t)ide Analog in Participants Co-infected with Hepatitis B and Hepatitis D Virus

JRCT ID: jRCT2071200049

Registered date:30/10/2020

Basic Information

• Recruitment status: Complete
• Health condition(s) or Problem(s) studied: Hepatitis D, Chronic
• Date of first enrollment: 30/11/2022
• Target sample size: 190
• Countries of recruitment: Brazil,Japan,China,Japan,Germany,Japan,Spain,Japan,France,Japan,United Kingdom Of Great Britain And Northern Irel,Japan,Italy,Japan,New Zealand,Japan,Russian Federation,Japan,Sweden,Japan,Turkey,Japan,Taiwan, Province Of China,Japan,United States Of America,Japan
• Study type: Interventional

Intervention(s)

JNJ-73763989 : JNJ-73763989 will be administered as a SC
injection.
Placebo : Matching placebo to JNJ-73763989 will be administered as a SC injection.
Entecavir (ETV) monohydrate : ETV monohydrate film coated tablet will be administered orally.
Tenofovir disoproxil : Tenofovir disoproxil film-coated tablet will be administered orally.
Tenofovir alafenamide (TAF) : TAF film coated tablet will be administered orally.

Outcome(s)

• Primary Outcome: Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination with Normal ALT at Week 48

Secondary Outcome

- Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND at Week 48
- Percentage of Participants With Normal ALT at Week 48
- Percentage of Participants with HBsAg Seroclearance at Week 48
- Percentage of Participants with >=2 kPa Reduction From Baseline in LSM assessed by VCTE (FibroScan) at Week 48
- Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND in Combination with Normal ALT
- Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline in Combination with Normal ALT
- Percentage of Participants with HDV RNA TND in Combination with Normal ALT
- Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline or HDV RNA TND
- Percentage of Participants with HDV RNA >=2 log10 IU/mL Decline From Baseline
- Percentage of Participants with HDV RNA TND
- Percentage of Participants with Normal ALT
- Time to Reach HDV RNA >=2 log10 IU/mL Decline or HDV RNA TND
- Change from Baseline in HDV RNA
- Changes from Baseline in ALT
- Percentage of Participants with Adverse Events (AEs) and Serious AEs
- Percentage of Participants with Abnormalities in Laboratory Parameters
- Percentage of Participants with Abnormalities in 12-lead Electrocardiogram (ECGs)
- Percentage of Participants with Abnormalities in Vital Signs
- Percentage of Participants with Abnormalities in Physical Examination
- Percentage of Participants with HBsAg Seroclearance and/or Seroconversion
- Change from Baseline Over Time in HBsAg
- Change from Baseline Over Time in HBeAg
- Change from Baseline Over Time in HBV DNA
- Percentage of Participants with HBsAg levels below/above different cut-offs
- Percentage of Participants with HBeAg levels below/above different cut-offs
- Percentage of Participants with HBV DNA levels below/above different cut-offs
- Percentage of Participants with HBsAg Change From Baseline Below/Above Different Cut-offs
- Percentage of Participants with HBeAg Change From Baseline Below/Above Different Cut-offs
- Percentage of Participants with HBV DNA Change From Baseline Below/Above Different Cut-offs
- Time to Reach Efficacy Thresholds such as HBsAg <1 IU/mL
- Percentage of Participants with HBV DNA Virologic Breakthrough
- Area Under the Plasma Concentration-time Curve (AUC) of JNJ-73763989 and Optionally NA
- Percentage of Participants with >=2 kPa Reduction from Baseline in LSM Assessed by VCTE (FibroScan)
- Change from Baseline in LSM Over Time Assessed by VCTE (FibroScan)
- Percentage of Participants with Sustained HDV Response Off-treatment Post end of JNJ-73763989 Treatment
- Percentage of Participants with HDV Relapse Post End of JNJ 73763989 Treatment
- Percentage of Participants with Sustained HBV Response Off-Treatment Post End of JNJ-73763989 Treatment.
- Percentage of Participants with HBV Flare (Virologic, Biochemical, and Clinical) Post End of Treatment
- Change from Baseline in Hepatitis B Quality of Life (HBQOL) Scale And Subscales

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: <= 65age old
• Gender: Both

Include criteria

- Medically stable based on physical examination, medical history, vital signs, electrocardiogram (ECG) at screening
- Chronic hepatitis B virus (HBV) and hepatitis D virus (HDV) co-infection with documentation at least 6 months prior to screening
- For Part 1: Hepatitis D RNA (HDV RNA) greater than or equal to (>=) 1000 international units per milliliter (IU/mL) at screening. For Part 2: must have HDV RNA values >= 500 IU/mL, and must have hepatitis B surface antigen (HBsAg) values less than or equal to (<=) 10,000 IU/mL at screening or HDV RNA values at screening are <= 100,000 IU/mL
- Alanine aminotransferase (ALT) greater than upper limit normal (ULN) but less than 10 times (ULN)
- Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included
- Highly effective contraceptive measures in place for female participants of childbearing potential or male participants with female partners of childbearing potential
- Non-cirrhotic participants and participants with compensated cirrhosis (Child Pugh class A) at screening (Part 1) and participants must have absence of cirrhosis and platelet count of >= 140,000 per deciliter (dL) for enrollment into Part-2

Exclude criteria

- Evidence of infection with hepatitis A, C, or E virus infection or evidence of human immunodeficiency, virus type 1 (HIV-1) or HIV-2 infection at screening
- History or evidence of clinical signs/symptoms of hepatic decompensation including but not limited to: portal hypertension, ascites, hepatic encephalopathy
- Evidence of liver disease of non-HBV/HDV etiology
- Signs of hepatocellular carcinoma (HCC)
- Significant laboratory abnormalities as defined in the protocol at screening
- Participants with a history of malignancy within 5 years before screening
- Abnormal sinus rhythm or ECG parameters at screening as defined in the protocol
- History of or current cardiac arrhythmia or history or clinical evidence of significant or unstable cardiac disease
- Participants with any current or previous illness for which, in the opinion of the investigator and/or sponsor, participation would not be in the best interest of the participant
- History of or current clinically significant skin disease or drug rash
- Participants with known allergies, hypersensitivity, or intolerance to JNJ-3989 or its excipients
- Contraindications to the use of entecavir (ETV), tenofovir disoproxil, or tenofovir alafenamide (TAF) per local prescribing information
- Participants who have taken any therapies disallowed per protocol
- Female participants who are pregnant, or breast-feeding, or planning to become pregnant while enrolled in this study or within 90 days after the last dose of study intervention
- Male participants who plan to father a child while enrolled in this study or within 90 days after the last dose of study intervention.
- Participants who had or planned major surgery, (example, requiring general anesthesia) or who have received an organ transplant
- Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)

Related Information

• Primary Sponsor: Nakama Takahiro
• Secondary ID(s): NCT04535544