Ignite Creation Date:
2024-05-05 @ 12:02 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226382
Status:
COMPLETED
Last Update Posted:
2010-06-11
First Post:
2005-09-23
Brief Title:
Treatment With Peginterferon Alfa-2a 40 KD of Chronic Hepatitis B Patients Who Have Failed Anti-viral Treatment
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
Treatment With Peginterferon Alfa-2a 40 KD PEGASYS of Chronic Hepatitis B Patients Who Have Failed Anti-viral Treatment A Pilot Study
Status:
COMPLETED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study is to investigate the HBV DNA suppression and HBeAg seroconversion among HBeAg positive patients pegylated interferon treatment at 24 weeks after end of treatment among patients who have failed anti-viral treatment in the past
Detailed Description:
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 products 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
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 products 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None