Treatment With Peginterferon Alfa-2a (40 KD) of Chronic Hepatitis B Patients, Who Have Failed Anti-viral Treatment
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Treatment With Peginterferon Alfa-2a (40 KD) (PEGASYS®) of Chronic Hepatitis B Patients, Who Have Failed Anti-viral Treatment. A Pilot Study.|
- HBeAg positive patients response is defined as HBeAg loss and presence of anti-HBe (HBeAg seroconversion), HBeAg Negative patients response is defined as DNA<20,000 copies/ml and ALT normalization both measured at week 72
- Percentage of patients with HBV DNA levels <100,000 copies/ml at week 72, Percentage of patients with HBV DNA levels <10,000 copies/ml at week 72
- - Percentage of patients with HBV DNA levels negative by PCR at week 72, ALT normalization at week 72, HBsAg seroconversion at week 72, Safety of treatment
|Study Start Date:||January 2005|
|Study Completion Date:||April 2008|
|Primary Completion Date:||April 2008 (Final data collection date for primary outcome measure)|
Drug: Pegylated Interferon-alfa-2a
Chronic hepatitis B is the commonest cause of liver cirrhosis and hepatocellular carcinoma in Hong Kong. Persistent high viraemia and necro-inflammation is associated with higher risk of liver-related complications.
Lamivudine and adefovir dipivoxil are the two anti-viral agents that can suppress the replication of the virus. However, these drugs using either alone or in combination only induce HBeAg seroconversion in less than 20% of patients. Most patients therefore required long-term treatment, which has a risk of development of drug resistance. Premature cessation of these anti-viral agents is usually accompanied by relapse of viraemia and hepatitis.
Pegylated interferon-alfa-2a is modified form of interferon with a 40 kDa polyethylene glycol strand attached to a recombinant interferon. This formulation increases the product's half-life from 7-10 hours to 77 hours. Therefore it can be administered on a more convenient once weekly basis. Pegylated interferon-alfa-2a monotherapy for 24 weeks has been shown to induce sustained HBeAg seroconversion in 35% of patients at the optimal dose of 180 mcg weekly. This drug has been found to be more effective than conventional interferon-alfa in the treatment of chronic hepatitis B as well as chronic hepatitis C.
Data on interferon-based treatment among chronic hepatitis B patients who have failed previous anti-viral treatment is scanty. It is uncertain whether pegylated interferon-alfa-2a treatment will be effective in this group of patients. This is a single-center, pilot study on the virological response of chronic HBV infection to pegylated interferon-alfa-2a among patients who have failed anti-viral treatment in the past. This study will investigate the HBV DNA suppression (and HBeAg seroconversion among HBeAg positive patients) pegylated interferon treatment at 24 weeks after end of treatment.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00226382
|Cheng Suen Man Shook Hepatitis Center, Institute of Digestive Disease, The Chinese University of Hong Kong, Prince of Wales Hospital|
|Hong Kong SAR, China|
|Principal Investigator:||Henry LY Chan, MD||Chinese University of Hong Kong|