The trial is taking place at:

Universitatsklinikum Essen | Ruhrlandklinik - Zentrum fur Schlaf- und Telemedizin

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A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus (REEF-D)

Janssen (J&J Innovative Medicine) logo

Janssen (J&J Innovative Medicine)

Status and phase

Active, not recruiting
Phase 2


Hepatitis D, Chronic


Drug: Placebo
Drug: JNJ-73763989
Drug: Tenofovir alafenamide (TAF)
Drug: Entecavir (ETV) monohydrate
Drug: Tenofovir disoproxil

Study type


Funder types



2023-506763-33-00 (Registry Identifier)
2020-001249-37 (EudraCT Number)
73763989HPB2004 (Other Identifier)

Details and patient eligibility


The purpose of the study is to evaluate on-treatment efficacy against hepatitis D virus (HDV) of JNJ-73763989 + nucleos(t)ide analog (NA) regimen compared to NA alone.


52 patients




18 to 65 years old


No Healthy Volunteers

Inclusion 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 (<=) 10000 IU/mL at screening or HDV RNA values at screening are <= 100000 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 >= 140000 per deciliter (dL) for enrollment into Part-2

Exclusion 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, esophageal varices or any laboratory abnormalities indicating a reduced liver function as defined in the protocol
  • 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 or excipients of the placebo content
  • 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
  • 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)

Trial design

Primary purpose




Interventional model

Parallel Assignment


Double Blind

52 participants in 2 patient groups, including a placebo group

Immediate Active Treatment arm: JNJ-73763989 + NA
Experimental group
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.
Drug: Tenofovir disoproxil
Drug: Entecavir (ETV) monohydrate
Drug: Tenofovir alafenamide (TAF)
Drug: JNJ-73763989
Deferred Active Treatment arm: Placebo+NA+JNJ-73763989+NA
Placebo Comparator group
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.
Drug: Tenofovir disoproxil
Drug: Entecavir (ETV) monohydrate
Drug: Tenofovir alafenamide (TAF)
Drug: Placebo
Drug: JNJ-73763989

Trial contacts and locations



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