Clinical Trials
OVERVIEW
The Division of Gastroenterology and Hepatology conducts clinical trials on novel therapeutics for various liver diseases, bringing promising and innovative therapies to our patients.
Our team has extensive experience selecting the right patients for the right trials.
Clinical trials are an important part of the research involved in developing new medical treatments. Enrolling in a clinical trial enables participants to take an active role in their own health care, gain entrance to new research, and contribute to medical science.
Participants must meet specific criteria to be eligible for enrollment in a clinical trial. Some research studies seek participants with illnesses or specific conditions to be studied in the clinicaltrial, while others ask for healthy participants.
CURRENT AND ONGOING TRIALS
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