Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00146705
Status:
COMPLETED
Last Update Posted:
2007-08-01
First Post:
2005-09-05
Brief Title:
Long Term Follow-up of Pegylated-Interferon Alpha-2b
Sponsor:
Foundation for Liver Research
Organization:
Foundation for Liver Research
Study Overview
Official Title:
Long Term Follow-up of Pegylated-Interferon Alpha-2b and Lamivudine Combination Therapy in Patients With Chronic HBV Infection
Status:
COMPLETED
Status Verified Date:
2007-07
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:
The aim of this study was to investigate the long term outcome of Peginterferon alpha-2b with or without the addition of lamivudine in patients with chronic hepatitis B
Detailed Description:
Interferon alpha therapy is a generally accepted agent for the treatment of chronic HBV infection and effective in about one third of patients Recently in the HBV 99-01 study pegylated interferon alpha-2b PEG-IFN has been shown to be effective in HBeAg-positive patients with chronic hepatitis B In this study 266 patients were randomized to receive PEG-IFN in combination with either lamivudine or placebo for 52 weeks
Thirty-six percent of patients receiving monotherapy and thirty-five percent receiving combination therapy had lost serum HBeAg at the end of the 26 week post-treatment follow-up period and there was no difference between treatment groups P 091 More patients on combination therapy initially seroconverted 44 of patients compared with 29 on monotherapy P 001 at the end of treatment but relapsed during follow-up Similar response patterns were seen when response was assessed by DNA suppression and change in ALT levels
In contrast to nucleoside analogues such as lamivudine and adefovir dipivoxil the virological and biochemical response to standard alpha-interferon has been shown to be durable after treatment discontinuationIn addition standard alpha-interferon leads to improved survival and reduction of hepatocellular carcinoma in chronic hepatitis B patientsPegylated interferons have shown to be effective in HBeAg-positive chronic hepatitis B patients but the durability of the response and long-term outcome of treatment have yet to be established
Thirty-six percent of patients receiving monotherapy and thirty-five percent receiving combination therapy had lost serum HBeAg at the end of the 26 week post-treatment follow-up period and there was no difference between treatment groups P 091 More patients on combination therapy initially seroconverted 44 of patients compared with 29 on monotherapy P 001 at the end of treatment but relapsed during follow-up Similar response patterns were seen when response was assessed by DNA suppression and change in ALT levels
In contrast to nucleoside analogues such as lamivudine and adefovir dipivoxil the virological and biochemical response to standard alpha-interferon has been shown to be durable after treatment discontinuationIn addition standard alpha-interferon leads to improved survival and reduction of hepatocellular carcinoma in chronic hepatitis B patientsPegylated interferons have shown to be effective in HBeAg-positive chronic hepatitis B patients but the durability of the response and long-term outcome of treatment have yet to be established
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