A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon

• Status: Completed
• Trial end date: 2014-10-01
• Target enrollment: 0
• Participant gender: All

Summary

The current proposed study aims to bring answers following issues: the antiviral efficacy and safety profiles in Korean Chronic Hepatitis B (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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yonsei University
• Treatments: Interferon alpha-2; Interferon-alpha; Interferons; Peginterferon alfa-2a

Criteria

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 therapy.

• 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 HDV.

• 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 excipients)

• A history of liver transplantation or planned for liver transplantation

• Subjects who receive concomitant therapy with telbivudine.