JNJ-73763989 + Antivirals for Hepatitis B and D Co-Infection

(REEF-D Trial)

Recruiting at 94 trial locations

Overseen By Study Contact

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Janssen Research & Development, LLC

Must be taking: Nucleos(t)ide analogs

Disqualifiers: Hepatitis A, C, E, HIV, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

52 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing a new drug called JNJ-73763989 combined with an existing medication to treat hepatitis D virus (HDV). The goal is to see if this combination works better than the current treatment alone. The new drug is expected to enhance the effectiveness of the existing medication.

Research Team

Janssen Research & Development, LLC Clinical Trial

Principal Investigator

Janssen Research & Development, LLC

Eligibility Criteria

This trial is for adults with chronic hepatitis B and D co-infection, stable health, no liver disease from other causes, no recent cancer, and not pregnant. They must have certain levels of HDV RNA in their blood and can't be too sick with liver problems or have a history of heart issues.

Inclusion Criteria

For Part 2: HDV RNA values >= 500 IU/mL and HBsAg values <= 10000 IU/mL at screening or HDV RNA values <= 100000 IU/mL at screening

Body mass index (BMI) between 18.0 and 35.0 kilogram per meter square (kg/m^2), extremes included

I do not have severe liver disease or my liver disease is mild (Child Pugh A), and my platelet count is high enough for Part-2.

Exclusion Criteria

Known allergies, hypersensitivity, or intolerance to JNJ-3989 or its excipients or excipients of the placebo content

I have been diagnosed with liver cancer.

Vulnerable participants (example, incarcerated individuals, individuals under a legal protection measure)

Treatment Details

Interventions

• Entecavir (ETV) monohydrate
• JNJ-73763989
• Tenofovir alafenamide (TAF)
• Tenofovir disoproxil

Trial Overview The study tests the effectiveness of JNJ-73763989 combined with nucleos(t)ide analogs (like Tenofovir or Entecavir) against hepatitis D virus compared to just the nucleos(t)ide analogs alone in treating co-infected patients.

Participant Groups

Group I: Immediate Active Treatment arm: JNJ-73763989 + NA Experimental Treatment 4 Interventions

Participants will receive JNJ-73763989 subcutaneous (SC) injection every 4 weeks (Q4W) along with NA (entecavir \[ETV\], tenofovir disoproxil, or tenofovir alafenamide \[TAF\]) once daily for 144 Weeks in Part 1 and for at least 96 weeks in Part 2.

Group II: Deferred Active Treatment arm: Placebo+NA+JNJ-73763989+NA Placebo Group 5 Interventions

Participants will receive matching placebo to JNJ-73763989 SC injection Q4W along with NA (ETV, tenofovir disoproxil, or TAF) once daily for 52 Weeks followed by JNJ-73763989 SC injection Q4W along with NA once daily for 96 weeks in Part 1 and for at least 48 weeks in Part 2.

Who Is Running the Clinical Trial?

Janssen Research & Development, LLC

Lead Sponsor

Trials

1,022

Recruited

6,408,000+

Giacomo Salvadore

Janssen Research & Development, LLC

Chief Medical Officer since 2023

MD from the University of Rome, Tor Vergata

Ricardo Attar

Janssen Research & Development, LLC

Chief Executive Officer since 2008

PhD in Molecular Biology from the University of Buenos Aires