Education and Training
A Study of JNJ-73763989 + Nucleos(t)Ide Analog in Participants Co-Infected With Hepatitis B and Hepatitis D Virus
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.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- drug: JNJ-73763989
- drug: Placebo
- drug: Entecavir (ETV) monohydrate
- drug: Tenofovir disoproxil
- drug: Tenofovir alafenamide (TAF)
Eligibility
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)
Ages Eligible for Study
18 Years - 65 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Recruiting