Hepatology Clinical Trials
NZSG is pleased to provide a list of clinical trials being run in Aotearoa New Zealand. Information is provided by outside sources. NZSG works at keeping the below information accurate - please let us know if there are non-active trials listed below.
Study Type
Trails of an experimental epigenetic editing therapy for chronic hepatitis B. This marks the first epigenetic editor being tested for an infectious disease and the second therapy aimed at modifying the hepatitis B genome to enter clinical trials.
Therapies are anticipated to provide curative options for patients suffering from a chronic disease that has been notably resistant to a cure. This trail intends to evaluate its experimental therapy, TUNE-401, in adult individuals with chronic HBV.
Requirements
Healthy Males and Females
Inclusion Citeria is:
- 18-75 years, no BMI cut-off
- On NUCs for >12 months
- ALT <1.5x ULN
- HBV DNA <90 IU/mL
- HBsAg >100 IU/mL
- WOCBP on contraception
Exclusion Criteria
- Fibroscan >8.8 KPa
- Other liver disease (ALD, MASLD)
- HCV, HDV, HIV infection
- Non-skin cancer within 5 years
- CrCl <60 ml/min
- Chronic steroid use (>5mg daily)
Study Visits
To find out more please contact the lead investigators in the recruiting cities:
Auckland Investigator: Ed Gane edgane@adhb.govt.nz
Christchurch Investigator: Jeffrey Ngu jeffrey.ngu@cdhb.health.nz
Study Type
A Phase III study of long-term therapy in patients with HDV
Requirements
Inclusion Criteria
- >18 years
- BMI 18-40
- Anti-HDV for at least 6 months
- Detectable HDV RNA
- Cirrhosis allowed up to CTP-6
- ALT <5x ULN
- HBV DNA <20 or started on NUCs
Exclusion Criteria
- HCV/HIV/HEV coinfection
- Other chronic liver disease (MASLD)
- Hepatocellular carcinoma
- Decompensation (CTP score ≥7)
- Platelets <60
- Albumin <28
- CrCl < 30 mL/min
Study Visits
To find out more about the study please contact the lead investigator Ed Gane at ed.gane@adhb.govt.nz
Study Type
A study to assess a gene therapy to correct the genetic mutation that drives AATD.
Requirements
- Male / Female >18 years
- A1AT ZZ or Z/null
- FEV1 >40%
- ALT <1.5x ULN; bilirubin normal
- Platelets >150
- Stage F1-F3 fibrosis/Liver stiffness <12
Study Visits
To be discussed with accepted participants. Core visits include:
- Single injection
- Open labelled (no placebo)
- 2 years then 15 years extended follow-up
Study Type
Target disease: Wilson's disease, a genetic disorder caused by mutations in the ATP7B gene that leads to copper buildup in the liver and brain.
Therapy: A prime editor named PM577, delivered via a lipid nanoparticle (LNP), which is designed to precisely correct the genetic mutations responsible for the disease.
Requirements
- Part 1: >18 years old; Part 2: 12-18 years old
- Part 1&2: on chelation therapy; Part 3: not on chelation
- H1069Q or R778L mutation
- ALT/AST <2.5x ULN; bilirubin <1.5x ULN
- Cirrhosis allowed but no acute or chronic liver failure
Study Visits
- Single injection
- Open labelled (no placebo)
- Serial (x3) Cu64 CT PET to monitor Copper metabolism
- 1 year then 15 years extended follow-up
Are you a clinician and a member of NZSG? If so, we’re building a page where you will be able to access trial data we may hold on research on our clinical data page – watch this space!
Clinical Data Page Clinical Data Page