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An Observational, Multi-Center, Cohort Study Evaluating the Antiviral Efficacy, Safety, and Tolerability in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon-alpha 2a (Pegasys®): TRACES STUDY

20 Years
65 Years
Open (Enrolling)
Chronic Hepatitis B

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Trial Information

An Observational, Multi-Center, Cohort Study Evaluating the Antiviral Efficacy, Safety, and Tolerability in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon-alpha 2a (Pegasys®): TRACES STUDY

- Korea is known to be an endemic area for HBV infection. Some studies have reported that
more than 95% of patients in Korea with chronic HBV have genotype C infection.

- Compared with other genotypes, genotype C is associated with increased viral loads,
higher histologic activity, more severe acute exacerbations, a longer viral clearance
phase and worse antiviral response to peg-interferon therapy.

- Long-term nucleos(t)ide analogue (NA) therapy is recommended for chronic hepatitis B
(CHB) patients with compensated and decompensated liver disease. However, a possibility
of cessation of antiviral treatment with oral NAs is unlikely due to rebound of HBV DNA
levels after termination of NAs administration. In addition, NA therapy has been
reported to have lower chance of HBsAg seroclearance compared to that with
immunomodulatory agents such as peginterferon.

- Pegasys® has been proved to induce HBsAg loss, which is the closest to cure of disease.
However, a better understanding of HBV treatment with Pegasys® in the real-life
clinical setting in Korea can be helpful for decision of treatment strategy in the
future. Asian experience with Pegasys® therapy in CHB is limited. Study populations of
investigator-initiated trials consist of selected group with smaller number of Korean
patients. Therefore, long-term efficacy and safety data in real practice with Pegasys®
treatment in both HBeAg-positive and -negative Korean patients are necessary.

- In addition, the current proposed collected data study may be helpful to bring answers
to many unresolved issues: the antiviral efficacy and safety profiles in Korean CHB
patients who are mostly infected with solely genotype C HBV, a proper duration of
Pegasys® therapy post-treatment durability or accumulation of HBeAg
seroconversion/HBsAg loss, preventable effect on long-term disease progression to liver
cirrhosis and liver cancer. In addition, this study aims to collect more data on the
efficacy and safety in a real-life clinical setting of Pegasys® therapy in patients
with CHB.

Inclusion Criteria:

- Adult subjects receiving treatment for CHB with PEGASYS according to standard of care
and in line with the current summary of product characteristics(SPC)/ local labeling
who have no contra-indication to PEGASYS therapy as per the local label.

- Adult chronic hepatitis B patients (20 years of age or older) who has been completed
or are currently receiving or are planned to receive Pegasys® as a first-line

- Those with baseline HBV DNA > 2,000 IU/mL and elevation of ALT level.

- HBeAg positive or HBeAg negative serologically proven chronic hepatitis B(CHB)

- Subjects treated with previous NAs therapy are eligible for this study.

Exclusion Criteria:

Subjects with ALT > 10 x ULN or evidence of hepatocellular carcinoma.

- Subjects should be without serological evidence of co-infection with HCV, HIV, or

- Subjects with decompensated liver disease, as well as pregnant or breast-feeding
women, will not be eligible for the study.

- Subjects should have no other diseases that might be contraindication to
peg-interferon therapy as per local SPC (e.g., severe psychiatric diseases,
immunological diseases, severe retinopathy or thyroid dysfunction, history of severe
pre-existing cardiac disease, etc)

- Subjects with other contra-indications to PEGASYS therapy as detailed in the label
(hypersensitivity to the active substance, to alpha interferons, or to any of the

- A history of liver transplantation or planned for liver transplantation

- Subjects who receive concomitant therapy with telbivudine.

Type of Study:


Study Design:

Observational Model: Cohort, Time Perspective: Prospective

Outcome Measure:

HBsAg loss or appearance of anti-HBs antibody in treatment-naïve Korean CHB patients treated with Pegasys

Outcome Time Frame:

2015 (up to 3 years)

Safety Issue:


Principal Investigator

Sang Hoon Ahn, MD. PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Internal Medicine, Yonsei Universtiy College of Medicine,


Korea: Institutional Review Board

Study ID:




Start Date:

January 2012

Completion Date:

January 2015

Related Keywords:

  • Chronic Hepatitis B
  • Chronic hepatitis B
  • pegylated Interferon-alpha 2a
  • Korean
  • Hepatitis
  • Hepatitis A
  • Hepatitis B
  • Hepatitis, Chronic
  • Hepatitis B, Chronic