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