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The Royal Adelaide Hospital (RAH) Hepatology/Viral Hepatitis Centre (VHC) provides a dynamic service for the South Australian public to access quality care and management of liver disorders and viral hepatitis infections.

The VHC established a clinical research unit over 15 years ago to enable access to new and innovative treatments for patients living with liver disease in South Australia. We have developed into an internationally recognised unit, with experience working with many different Sponsors across a wide range of liver disorders.

Our unit is capable of conducting clinical trials in Phase 1 (in conjunction with CMAX -https://www.cmax.com.au/) and Phase 2 - 4 trials, as well as Long Term Registry Studies, Audits, Observational Studies and Translation Research. The number of clinical trials in respective areas for the last 3 years is as listed below -
o Hepatitis C Virus (HCV) - 53
o HCV/HIV co-infection - 4
o Hepatitis B Virus (HBV) - 8
o Recently Acquired HCV - 7
o Hepatocellular Carcinoma (HCC) - 3
o Non-alcoholic steatohepatitis (NASH) - 7
o Primary biliary cirrhosis (PBC) - 3
o Chronic liver disease/thrombocytopenia - 1
o Auto Immune Hepatitis – 1
o Hepatic Encephalopathy – 1
Our Health region is very supportive of research; the evidence of this is in the fast turnaround times for both Ethics and Governance reviews and approvals. Once protocols are approved, The Royal Adelaide Hospital Research Ethics Committee will review in real time. This has resulted in our site being the lead site of preference for many sponsors.

https://www.rahresearchfund.com.au/rah-research-institute/for-researchers/clinical-trials/

Our team is proud of our exemplary track record in clinical trials resulting in 95% of patient recruitment goals being met and less than a 2% drop-out rate. We also boast low screen failure rates, due to careful and thorough pre-screening of patients.
The VHC is a unique centre formed collaboratively between the Hepatology and Infectious Disease Units within the Royal Adelaide Hospital - the largest public hospital in South Australia. Our multidisciplinary team consists of physicians, nurses and scientists.

Our unit works closely with two other major teaching hospitals (The Queen Elizabeth Hospital and Lyell McEwin Hospital Gastroenterology/Hepatology and Infectious Disease Units), covering two of the state’s three health networks - some of our Consultants work in more than one hospital - enabling excellent lines of communication. The large number of clinical research trials run within our unit, over the past 15 years, has generated a team of motivated clinicians that have seen first-hand the direct benefits to patients from their involvement in these trials.

The links between these three major hospitals results in access to a large and varied demographic of patients with chronic liver disease including Hepatocellular Carcinoma (HCC), NAFLD/NASH, PBC, PSC, HBV, HBV/HDV co-infection, HCV and HIV Co-infections. Demographics include large cohorts of patients from South East Asia, The Middle East, Europe and Africa. Access to private patients, of consultants working at the above hospitals, is also possible.

A fortnightly HCC MDT meeting, including hepatologists, medical and radiation oncology physicians, hepatobiliary surgeons, interventional radiologists, pathologists and nurses from across all three hospitals, is held to discuss and manage the ongoing care of patients. This is an excellent conduit for patients with advanced HCC to be referred for treatment in clinical research protocols. Each meeting assesses approximately 12 – 15 patients, including 1- 3 new referrals.

Study Search 

  • Primary Biliary Cirrhosis - Intercept 747-302

    Currently Recruiting  -  A Phase 3b, Double-Blind, Randomized, Placebo-Controlled,
    Multicenter Study Evaluating the Effect of Obeticholic Acid on
    Clinical Outcomes in Subjects with Primary Biliary Cirrhosis 

  • NASH Intercept - 747-303

    Currently recruiting  -  A Phase 3, Double-Blind, Randomized, Long-Term, Placebo-Controlled, Multicenter Study Evaluating the Safety and Efficacy of Obeticholic Acid in Subjects with Nonalcoholic Steatohepatitis

  • NASH - Tobira AURORA 652-306

    Currently recruiting  -  A randomized, double-blind, placebo‑controlled, multinational study to evaluate the efficacy and safety of cenicriviroc (CVC) in adult subjects with NASH and Stage 2 to 3 liver fibrosis (NASH CRN system). The study will be conducted in 2 parts: Part 1 will evaluate the efficacy of CVC at Year 1 based on a surrogate endpoint, using liver biopsy; Part 2 will evaluate the effect of CVC on long-term clinical outcomes, including all-cause mortality and liver-related events.

  • Hepatocellular Carcinoma - Sillagen JX594-HEP024

    Currently recruiting  -  A Phase 3 Randomized, Open-Label Study Comparing Pexa-Vec (Vaccinia GM-CSF /
    Thymidine Kinase-Deactivated Virus) Followed by Sorafenib Versus Sorafenib in Patients
    with Advanced Hepatocellular Carcinoma (HCC) Without Prior Systemic Therapy

  • NAFLD/NASH Pfizer Inc - C1171002

    Currently recruiting  - A Phase 2a, randomized, double-blind, placebo-controlled, dose-ranging, parallel group study to evaluate safety, tolerability, and pharmacodynamics of PF 05221304 administered daily for 16-weeks to adult subjects with nonalcoholic fatty liver disease. 

Information

Therapeutic Areas

Demographic Data

  • SITE INFORMATION 
  • Start year clinical research2004
  • Phases of clinical studiesPhase I, Phase II, Phase III, Phase IV
  • Types of studiesDrugs, Medical Devices, Vaccines
  • PopulationsAdult 18-64 yrs, Senior 65 yrs and over
  • SPECIFIC SITE INFORMATION 
  • Type of siteAcademic
  • # of employees involved in research6
  • # of investigators8
  • Days openMonday, Tuesday, Wednesday, Thursday, Friday
  • Extended office hoursYes
  • Overnight facilitiesYes
  • Dry iceYes
  • Blinded pharmacistYes
  • Dedicated monitoring spaceYes
  • Internet access for the monitorYes
  • Onsite laboratoryYes
  • Central laboratoryYes
  • Infusion capabilityYes
  • Shipping optionsFedEx, DHL, Other
  • REGULATORY INFORMATION 
  • Contact for regulatory documentsMegan Phelps
  • Regulatory phone number+61 8 7074 2193
  • # of days to turn around regulatory documents5
  • Type of IRB used by this siteCentral, Local
  • How often does your local IRB meet?Monthly
  • Appropriate storage facilities for productYes
  • Able to appropriately store Schedule II drugsYes
  • FINANCIAL INFORMATION 
  • # days to turn around budget and contract10