Current Research and Clinical Studies at NUH

TELBIVUDINE (LdT) VS. LAMIVUDINE FOR HEP B AND DECOMPENSATED LIVER DISEASE

Aims:

  • To compare efficacy, safety & tolerability of LdT vs Lamivudine.

Method:

  • Patients with decompensated liver disease will be randomized into 0:0 ratio in receiving either LdT or lamivudine.

Advantage of the study:

  • New antiviral agent for decompensated liver disease can be developed.

  • Patients who take part in the study receive free medication, free blood tests, and consultation.
ENTACAVIR Vs ADEFOVIR FOR CHRONIC HEP B WITH LAMIVUDINE RESISTANCE & HEPATIC DECOMPENSATION

Introduction:

  • Entacavir has good results in suppressing hep B virus in Phase I & II study. It may be more effective than adefovir , with no renal toxicity.

Aim:

  • To compare safety & efficacy of Entacavir Vs Adefovir in patients with Lamivudine resistance & Hepatic decompensation.

Method:

  • Patients will be randomised in 1:1 ratio in receiving either entacavir or adefovir.

Advantage of the study:

  • New advantageous agent for decompensated liver disease can be developed.

  • Patients who take part in the study receive free medication, free blood tests, and consultation.
NEW HEP B VACCINE - DYNAVAX VS ENGERIX-B

Introduction:

  • HBV vaccine was first introduced in 1981 and much progress has been made in prevention of HBV infection.

  • Use of current vaccines is hindered by the requirement of 3 doses over a 6 month period.

  • Only 10-20% of adult vaccine recipients mount a protective serum antibody titer (> 10mIU/ml) within 1 month of the first dose. It is also hindered among the non-responders, especially those over 40 years old, patients (35-40%) with renal failure or diabetes (30-60%).

Aim:

  • To compare safety & efficacy of dynavax vs engerix-B

QUALITY OF LIFE STUDY

Introduction:

  • How hepatitis B affect patients' life is uncertain.

Aims:

  • To examine how hepatitis B affects the quality of life of hepatitis B patients.

Method:

  • Study subjects are required to fill up a questionnaire, which usually takes about 15 minutes.

  • All information will be kept utmost confidential and only the investigators will have access to it.

  • At the end of the study, we aim to find out how hepatitis B has affected their quality of life, and whether clinical complications like liver hardening, flares, and liver cancer can severely affect patients' life.

Advantage of the study:

  • It allows doctors to understand which aspects of patients are adversely affected by hepatitis B and allows them to help hepatitis b patients in specific areas.

STUDY ON NATURAL HISTORY OF HEP B

Introduction:

  • Many studies showed that up to 40% of hepatitis B carriers would develop long term problems such as flares, liver cirrhosis, liver failure, and liver cancer. However, the only risk factors identified so far are male gender,family history of liver cancer, and advanced age.

  • It is uncertain if other host factors or viral factors are important in determining long-term outcome with hepatitis B patients.

Aim:

  • This study aims to find out factors that affect long-term outcome of Hepatitis B carriers.

Method:

  • Study subjects are required to answer some basic questions, and have some blood taken for special viral tests on hepatitis B at baseline.

  • Subjects will be followed up as usual.

  • At the end of the follow up, patients with clinical complications will be compared with those without. Factors associated with complications will be evaluated.

Advantage of the study:

  • Medical professionals will gain better understanding of the natural history of chronic hepatitis B. This will allow them to better predict the long-term risk of complications in hepatitis B carriers.

INFLIXIMAB IN TREATMENT OF SEVERE HEP B FLARES

Introduction:

  • Patients with severe flares from hepatitis B had high mortality of up to 50%.

  • Infliximab may be useful in controlling damage of hepatitis B virus in patients with flares.

Aim:

  • To evaluate the efficacy of infliximab in patients with severe flares.

Methods:

  • Patients with severe flares are randomised 1:1 ratio in receiving either infliximab or placebo to determine if there is a difference in outcome.

Advantage:

  • New treatment like infliximab can be evaluated.

REMOFOVIR VS. ADEFOVIR FOR CHRONIC HEP B

Introduction:

  • Adefovir is a new antiviral agent recently approved for treatment of hepatitis B. However, adefovir is associated with kidney side effects in about < 2% of patients.

  • Remofovir, a new antiviral agent, has no known kidney side effect and may be more effective than adefovir in suppressing hepatitis B virus.

Aim:

  • To compare efficacy of remofovir vs. adefovir in treatment of hepatitis B

Methods:

  • Patients will be randomised in 1: 1 ratio in receiving remofovir or adefovir and will be monitored closely for at least two years.

  • The efficacies of the two drugs will be compared.

Advantage of the study:

  • New antiviral agent can be developed

  • Patients who take part in this trial can receive free medication, free blood tests, and consultation.

LdT VS. LAMIVUDINE FOR HEP B CIRRHOSIS

Introduction:

  • Lamivudine has been shown to improve clinical status in patients with hepatitis B related cirrhosis, but it is associated with development of resistant mutants on prolonged usage.

Aim:

  • To compare efficacies of LdT (a new antiviral agent) vs. lamivudine in patients with hepatitis B-related cirrhosis.

Methods:

  • Patients with cirrhosis will be randomised into 1:1 ratio in receiving either LdT or lamivudine

  • The efficacies of the 2 drugs will be compared.

Advantage of the study:

  • New antiviral agent for hepatitis B cirrhosis can be developed

  • Patients who take part in the study receive free medication, blood tests, and consultation.