Clinical trials conducted in the Gastroenterology and Liver Department

Within our clinical service, there are occasions where participation in a clinical trial is a good choice for patients, either to access therapies not otherwise available for their condition or because it is unclear which of the available choices is the optimal one. Under the governance of South Western Sydney Local Health District Ethics Committee, participation in clinical trials may be offered to our patients. Each year clinical trials will vary, so keep an eye out on this page for any new trials as they become available.

When you attend our clinical service, you may be invited to consider information about clinical trials available for your condition. Clinical trials will remain a small but important part of our work, ensuring patients can access cutting edge new therapies and that as clinicians we are always questioning existing practices and alert to new treatments that may improve patient outcome.

If you would like to learn more about any of the clinical trials below, please email SWSLHD-LiverpoolGastro@health.nsw.gov.au using the subject line “Clinical Trials” and the name of the study you are interested in, and we will be in touch!

  • Primary Sclerosing Cholangitis

    PHASE 2

    VISTAS - A Randomized Double-Blind Placebo-Controlled Study to Evaluate the Efficacy and Safety of Volixibat in the Treatment of Cholestatic Pruritus in Patients with Primary Sclerosing Cholangitis

    NCT04663308

    The purpose of this clinical research study is to learn more about the use of the study medicine, volixibat, for the treatment of pruritus (itching) associated with Primary Sclerosing Cholangitis (PSC), and to assess the possible impact on the disease progression of PSC.

    INCLUSION CRITERIA

    1. Adults aged 18 and over
    2. Have been diagnosed with Primary Sclerosing Cholangitis (PSC), either large duct or small duct type
    3. Experience itching (pruritus) related to PSC
    4. Can still join if taking certain medications for itching or PSC, as long as other conditions are met
    5. People with Inflammatory Bowel Disease (IBD) can join, if they meet extra requirements

    EXCLUSION CRITERIA

    1. Itching caused by something other than PSC
    2. Signs of severe liver damage or past serious liver complications
    3. Have had surgeries that affect how bile moves through the body (like ileostomy or certain bowel surgeries)
    4. Have or are suspected to have other liver diseases (except PSC with autoimmune hepatitis, which is okay)
    5. Had certain procedures on the bile ducts (like stents or drains) in the last 12 weeks
    6. Blood test results are too far outside the normal range for liver or kidney function, clotting, or other measures
    7. Have had a liver transplant

    MEDICATION INFO

    Oral Tablets
    Once Daily

    Primary Sclerosing Cholangitis

  • Hepatitis B

    PHASE 1b/2

    BJT-008-001 - A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod Alone and in Combinations in Subjects with Chronic Hepatitis B Infection

    ACTRN12624000808549

    This study is testing a new treatment for chronic hepatitis B in adults aged 18–65 who are already on standard medication and don’t have serious liver damage.

    It aims to check if the treatment is safe and if it helps control the virus.

    Small groups will try different doses. Most will get the real treatment, and one person in each group will get a placebo. A safety team will monitor the results at each step.

    INCLUSION CRITERIA

    1. Adults aged 18 to 65 years
    2. Have had chronic hepatitis B for at least 6 months
    3. Be on standard hepatitis B medication (nucleos(t)ide therapy) for at least 2 months, and agree to keep taking it during the study
    4. Have a low level of hepatitis B virus in your blood
    5. Have a detectable amount of hepatitis B surface antigen (HBsAg) in your blood

    EXCLUSION CRITERIA

    1. Pregnant, breastfeeding, or not willing to use birth control during the study
    2. Have signs of serious liver damage, like fluid in the belly, confusion, or bleeding from veins in the stomach or esophagus
    3. Have other liver diseases besides hepatitis B (like hepatitis C, hepatitis D, or alcohol-related liver disease)
    4. Have HIV, hepatitis C, or hepatitis D
    5. Have had a liver transplant or other organ transplant
    6. Are taking immune-suppressing medications, like steroids
    7. Have or had liver cancer
    8. Are allergic to the study drug or have had serious reactions to injections
    9. Have major heart problems, autoimmune diseases, or cancer in the past 3 years
    10. Have a history of heavy alcohol use or drug abuse (except cannabis)

    MEDICATION INFO

    Subcutanous Injection
    Once Weekly

    Hepatitis B

If you have any enquiries or would like to make an appointment, please email:

Gastroenterology and Liver
Clinic E (123), Level 1
Liverpool Hospital
Corner of Elizabeth and Goulburn Streets
LIVERPOOL NSW 2170

  02 8738 4085
  FAX: 02 8738 7960
Our phones cannot always be answered, so the best way to contact us is via email or fax

8.30am - 4.00pm
Monday to Friday

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