Clinical trials

Many pharmaceutical companies are working on a cure for hepatitis B. These cures will target people living with chronic hepatitis B. The process includes clinical trials, which give patients a chance to get involved with developing a cure.

The criteria for participating in these trials varies, so please check your eligibility with the clinical trial unit nearest you.

What is a clinical trial?

A clinical trial is a study that observes or treats patients to develop or discover new treatments or medications. It means scientists can accurately evaluate medications by studying their effects on healthy people and others who have the condition the drug is designed to target.

Volunteer participants are vital to clinical trials. As a participant, your rights are paramount and will be respected. All trial operators will ensure prospective participants fully understand what's involved before giving consent.

How can I get involved?

Please contact the clinical trial facility nearest you if you’re interested in being considered for trials or would like more information about what’s involved. It's also recommended you involve your doctor so you can make an informed decision.

People accepted into clinical trials may be reimbursed for their time, but this varies and is dependent on the trial.

What organisations run clinical trials?

Facilities currently running clinical trials in New Zealand are:

NZCR - Auckland Clinical Studies

Aotearoa Trials - Middlemore Clinical Trials Unit

Waikato DHB Clinical Trials Unit

Capital and Coast DHB Clinical Trials Unit

Momentum Clinical Research (P3 Research) (NZ-wide)

Current Clinical Trials

The “Rhythm” Clinical Trial

New Zealand Clinical Research (NZCR) is assessing the safety and effectiveness of Tune-401 – an investigational epigenetic gene silencing approach for the treatment of Chronic Hepatitis B.

Epigenetic gene silencing (also known as HBV viral silencing) are LNP-RNA drugs that bind to DNA and switch off target genes in order to treat illness and disease. They are a form of genetic medicine– related to gene editing, but different in that epigenetic proteins cannot and do not cut DNA or alter DNA sequence. Tune-401 targets HepB Virus DNA, and aims to switch off the genes essential for viral reproduction and infection.

Am I suitable for this trial? Are you…..

18-75 years old
HepB positive for greater than 12 months
Taking antiviral medication (NUCs) for more than 12 months
Have a HBV DNA less than 90 IU/mL
Not cirrhotic
No other significant medical conditions e.g. cancer, heart failure.

Potential Benefits:

May achieve improved control and clearance of HepB infection
Possibility of lasting effect from a one-time only treatment
Precise, targeted approach with no risk of cutting DNA

Potential Risks:

Epigenetic silencing is an investigational approach that has not yet been approved for the treatment of chronic HepB in humans; since no clinical data are available, its precise effects and side effects are not yet known.
Using Lipid Nanoparticles (LNPs) to deliver drugs like Tune-401 has been known to create toxicity and immune/allergic reactions in some individuals.

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