A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon
|ClinicalTrials.gov Identifier: NCT01531166|
Recruitment Status : Completed
First Posted : February 10, 2012
Last Update Posted : August 17, 2016
|Condition or disease||Intervention/treatment|
|Chronic Hepatitis B||Drug: pegylated Interferon-alpha 2a|
- 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.
|Study Type :||Observational|
|Actual Enrollment :||500 participants|
|Official Title:||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|
|Study Start Date :||September 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||October 2014|
|Chronic hepatitis B||
Drug: pegylated Interferon-alpha 2a
Pegasys 180mcg/PFS/ subcutaneous injection / Once a week
Other Name: Pegasys
- HBsAg loss or appearance of anti-HBs antibody in treatment-naïve Korean CHB patients treated with Pegasys [ Time Frame: 2015 (up to 3 years) ]
- Sustained suppression of HBV DNA [ Time Frame: 2015 (up to 3 years) ]
- HBeAg loss and seroconversion in HBeAg-positive CHB [ Time Frame: 2015 (up to 3 years) ]
- ALT normalization [ Time Frame: 2015 (up to 3 years) ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01531166
|Korea, Republic of|
|Sang Hoon Ahn|
|Seoul, Seodaemun-gu, Korea, Republic of, 120-752|
|Study Chair:||Sang Hoon Ahn, MD. PhD||Department of Internal Medicine, Yonsei Universtiy College of Medicine,|