Clinical Trials Unit

We need written consent from all participants in our clinical trials. We will fully discuss all aspects of your participation with you before you give consent. You are welcome to ask questions and clarify information at any time throughout the study.

We have a comfortable waiting room and reception area for when you first arrive.

Most participants are here for between an hour and half a day, depending on the study. However, some studies require a longer stay, and some patients may need to stay overnight or longer.

Our patient lounge has comfy chairs, a table and a television. There is a kitchen for making refreshments, including a microwave and fridge. You are welcome to bring in food.

If you are staying overnight or longer, your meals will be provided. We can cater for special dietary requirements.

Each bed for patients staying overnight has a dedicated television.

Ethics approval is required for all trials, and guidelines exist that set out the established ethical standards that all researchers must meet when undertaking health and disability research in New Zealand.

Read more about this on the Health and Disability Ethics Committees website.

Health and Disability Ethics Committees (external link)

For more clinical trials in New Zealand, visit CenterWatch.

New Zealand — CenterWatch (external link)

If you would like to participate in one of our trials, or would like more information, call 04 918 5117 or email marina.dzhelali@ccdhb.org.nz

The Clinical Trials Unit does not recruit healthy volunteers. If you are healthy and would like to volunteer for a trial, you can contact the Medical Research Institute of New Zealand.

Volunteer participation — Medical Research Institute of New Zealand (external link)

Our Clinical Trials Unit has a dedicated pharmacy for dispensing and storing study agents.

Services include:

• controlled ambient room temperature with 24-hour monitoring
• secure storage of study drugs and devices
• a facility for the preparation of monoclonal antibodies and cytotoxic drugs
• 24-hour alarm-monitored refrigerated storage (4°C) of IP.

As part of a regional hospital, we also have access to all the usual hospital services, including our hospital pharmacy.

We have a dedicated laboratory in our unit with up-to-date services, including:

• secure access and storage
• temperature controlled centrifuges (chilled and regular)
• 24-hour monitored freezer storage (-5°C, -20°C and -80°C)
• sample processing facilities
• biohazard disposal
• sample incubator.

We also have access to all hospital services, including analytical laboratory processing.

Our dedicated research unit includes a range of facilities to meet the needs of different clinical trials, including:

• a 4-bed isolation suite — equipped with monitoring equipment, plus isolation toilet and shower
• 2 double bedrooms — with monitoring equipment, suitable for studies requiring a calm and private environment
• a 4-bed suite — with monitoring equipment suitable for day-cases or overnight studies
• spacious, multi-functional procedure room — capable of accommodating specialised equipment
• treatment room and phlebotomy facilities — for taking samples and giving treatments
• 2 consulting suites
• research kitchen — a dedicated space is available for research related to dietary and nutritional intake. The kitchen also has tea- and coffee-making facilities and television
• 2 interview rooms, ideally suited for:
  • informed consent
  • monitoring visits
  • interviews
  • questionnaire completion.

ANZACS -QI

New Zealand-wide acute coronary syndrome audit (MOH)

This project is currently active.

• Clinical director: Alex Sasse
• Study coordinators: Beverley Scott and Donna Wylie

ORIGAMI

Inflammation genetics and risk following Myocardial Infarction

This study is in follow-up.

• Study coordinators: Bronwyn Davies and Donna Wylie

PROTECT-ICD

Programmed Ventricular Stimulation to Risk Stratify for Early Cardioverter-Defibrillator (ICD) Implantation to Prevent Tachyarrhythmias Following Acute Myocardial Infarction

This study is currently recruiting participants.

Primary objective: The PROTECT-ICD trial is a physician-led, multi-centre randomised controlled trial targeting prevention of sudden cardiac death in patients who have poor cardiac function following a myocardial infarct (MI). The trial aims to assess the role of electrophysiology study (EPS) in guiding implantable cardioverter-defibrillator (ICD) implantation, in patients early following MI (first 40 days). The secondary aim is to assess the utility of cardiac MRI (CMR) in analysing cardiac function and viability as well as predicting inducible and spontaneous ventricular tachyarrhythmia when performed early post MI.

• Principal investigator: Matthew Webber
• Study coordinator: Beverley Scott

PROTECT-ICD — ClinicalTrials.gov (external link)

M16-066 Abbvie

A Study to Assess the Efficacy and Safety of Risankizumab in Subjects with Ulcerative Colitis Who Responded to Induction Treatment in M16-067 or M16-065

This study is currently recruiting participants.

Primary objective: The purpose of this multicenter, randomized, double-blind, placebo-controlled 52-week maintenance and an open-label extension study is to evaluate safety and efficacy of risankizumab in subjects with ulcerative colitis (UC) in subjects who responded to induction treatment with risankizumab in a prior AbbVie study of risankizumab in UC.

• Principal investigator: Ben Griffiths
• Study coordinator: Jonathan Barrett

A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis (COMMAND) — ClinicalTrials.gov (external link)

BRII-179 for Chronic Hepatitis B

Brii-179-001: A Study to Evaluate Safety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) among Subjects with Chronic Hepatitis B

This study is currently recruiting participants.

Primary objective: The main goal of this study is to assess the safety and tolerability of two dose levels of BRII-179 in people without significant liver damage but with chronic HBV infection. The study will also assess the antiviral activity of BRII-179 (VBI-2601) given by intramuscular injection. To take part in this study, participants must be 18-60 years old and have been on a drug that suppresses replication of the hepatitis B virus e.g. tenofovir or entecavir and have to continue to take this drug throughout the study. If eligible, participation in the study will last up to several months.

• Principal investigator: Dr Nigel Stace
• Study coordinator: Gizelle Lopez

A Study to Evaluate Safety, Tolerability, and Antiviral Activity of BRII-179 (VBI-2601) among Subjects with Chronic Hepatitis B — ANZCTR (external link)

O'HAND MS (WA40404)

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults with Primary Progressive Multiple Sclerosis

This study will begin recruiting participants soon.

Primary objective: This study will evaluate the efficacy and safety of ocrelizumab compared with placebo in participants with primary progressive multiple sclerosis (PPMS), including participants later in their disease course. This study focuses on upper limit disability progression.

• Principal investigator: Dr Jennifer Taylor
• Study coordinator: Bri Boljonis

A Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis (O'HAND) — ClinicalTrials.gov (external link)

TASTE

Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation (TASTE) Trial

This study is not yet recruiting participants.

Primary objective: The aim of this study is to test the hypothesis that patients who have experienced an acute hemispheric ischaemic stroke who have a penumbra on perfusion CT or MRI within 4.5 hours of symptom onset will have less disability at 3 months when treated with intravenous Tenecteplase (IV TNK) compared to intravenous Alteplase(IV tPA). This is a Phase III Multicentre, prospective, randomised open label blinded endpoint (PROBE) study.

• Principal investigator: Anna Ranta
• Study coordinator: Bri Boljonis

Tenecteplase versus Alteplase for Stroke Thrombolysis Evaluation (TASTE) Trial — ANZCTR (external link)

Koru

A Phase 1b, Multicentre, Open Label, Study of the Efficacy, Safety and Tolerability of R131 Ointment in Women with Cytological Abnormalities of the Uterine Cervix

This study is currently recruiting participants.

Primary objective: This study aims to investigate efficacy, safety and tolerability of R131 vaginal ointment in women with low grade and high grade cervical intraepithelial neoplasia (CIN) who have been diagnosed with Human papilloma virus (HPV).

• Principal investigator: Amanda Tristram
• Study coordinator: Michelle Hennessy

A Phase 1b, Multicentre, Open Label, Study of the Efficacy, Safety and Tolerability of R131 Ointment in Women with Cytological Abnormalities of the Uterine Cervix  (external link)— ANZCT (external link)R

FeMME

This study is in start-up.

• Principal investigator: Amanda Tristram
• Study coordinator: Marina Dzhelali

Medical Oncology

Breast: MK3475 KEYNOTE-756

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination with Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/HER2-) Breast Cancer

This study is currently recruiting participants.

Primary objective: The purpose of this randomized, double-blind, phase III study is to assess the efficacy and safety of pembrolizumab (MK-3475) versus placebo in combination with neoadjuvant (pre-surgery) chemotherapy and adjuvant (post-surgery) endocrine therapy in the treatment of adults who have high-risk early-stage estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) breast cancer.

• Principal investigator: Sarah Barton
• Research coordinator: Judy Murray

Study of Pembrolizumab (MK-3475) Versus Placebo in Combination With Neoadjuvant Chemotherapy & Adjuvant Endocrine Therapy in the Treatment of Early-Stage Estrogen Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative (ER+/​HER2-) Breast Cancer (MK-3475-756/​KEYNOTE-756) — ClinicalTrials.gov (external link)

Melanoma: MK3475 KEYNOTE-587

Long-term Safety and Efficacy Extension Study for Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab

This study is currently recruiting participants.

Primary objective: A Multicenter, Open label, Phase III Extension Trial to Study the Long-term Safety and Efficacy in Participants with Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab Trial

• Principal investigator: Catherine Barrow
• Research coordinator: Susan Millmow

Long-term Safety and Efficacy Extension Study for Participants With Advanced Tumors Who Are Currently on Treatment or in Follow-up in a Pembrolizumab (MK-3475) Study (MK-3475-587/​KEYNOTE-587) — ClinicalTrials.gov (external link)

Pancreas: PURPLE Registry

Understanding Routine Practice and Lifting End results (PURPLE): A Prospective Pancreatic Cancer clinical registry

Primary objective: This project is non-interventional registry of the treatment and outcomes of patients with pancreatic cancer. This registry will capture data on presentation and the disease course of pancreatic cancer, surgical interventions for primary and metastatic disease, prescription of systemic therapies, and information regarding multi-disciplinary management and outcomes of this disease in the routine clinical practice setting.

This registry is currently enrolling participants.

• Principal investigator: Kate Clark
• Research coordinator: Tali Cocker

Pancreatic cancer: Understanding Routine Practice and Lifting End Results (PURPLE). A Prospective Pancreatic Cancer Clinical Registry — ANZCTR

Radiation Oncology

Breast: EXPERT ANZBCTG

EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer

This study is currently recruiting participants.

Primary objective: This is a randomised, phase III, non-inferiority trial evaluating radiation therapy versus observation following breast conserving surgery and planned endocrine therapy in patients with stage I breast cancer of luminal A subtype defined using the Prosigna (PAM50) Assay.

• Principal investigator: Anna Nicholson
• Research coordinators: Judy Murray, Debra Morris

EXamining PErsonalised Radiation Therapy for Low-risk Early Breast Cancer (EXPERT) — ClinicalTrials.gov (external link)

Haematology

CML: KISS

Kinase Inhibition with Sprycel Start up

This study is currently recruiting participants.

Primary objective: This phase II study will investigate the efficacy and safety of a treatment plan for patients with newly diagnosed CML-CP, where dasatinib will be used to more rapidly induce a molecular response (MR3.0) within 12 months, after which imatinib will be used to maintain the CML in that remission. It is hypothesised that imatinib is safe and effective in maintaining MR3.0 in patients with CML who achieve MR3.0 at 12 months following initial induction therapy with dasatinib.

• Principal investigator Travis Perera
• Research coordinator: Anjela Stewart

KISS Study: Kinase Inhibition With Sprycel Start up (KISS) (external link)

Myeloma: MRDR Registry

Myeloma & Related Diseases Registry (Monash University)

This registry is currently enrolling participants.

Primary objective: The Myeloma and Related Diseases Registry (MRDR) is a register of patients diagnosed with multiple myeloma, monoclonal gammopathy of undetermined significance (MGUS), plasma cell leukaemia or plasmacytoma. The MRDR collects data on patterns of treatment and variation in patient outcomes (both survival and quality of life). Ultimately, it will help clinicians and hospitals to provide the best possible care to people with these conditions and allow evaluation of the translation of advances in therapy (such as the introduction of new targeted therapies) into long-term outcomes, outside the setting of clinical trials.

• Principal investigator: Anup George
• Research coordinator: Anup George, Kelly Harrison, CTU

Myeloma and Related Diseases Registry (external link)

BELIEVE 1

Research — Wellington Intensive Care Unit (external link)