Ignite Creation Date:
2024-05-05 @ 12:03 PM
Last Modification Date:
2024-10-26 @ 9:19 AM
Study NCT ID:
NCT00226447
Status:
COMPLETED
Last Update Posted:
2008-10-24
First Post:
2005-09-23
Brief Title:
Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in Chronic Hepatitis B Patients
Sponsor:
Chinese University of Hong Kong
Organization:
Chinese University of Hong Kong
Study Overview
Official Title:
A Study on the Viral Kinetics of Different Regimens of Pegylated Interferon and Lamivudine Combination Therapy in HBeAg Positive Chronic Hepatitis B
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:
The aim is to investigate the best treatment regime of PEG-Intron A and lamivudine combination in terms of viral clearance in chronic hepatitis B patients
Detailed Description:
Chronic hepatitis B is a major cause of mortality and morbidity in Hong Kong and most Southeast Asian countries The efficacy interferon-alfa IFN-alfa or lamivudine monotherapy is far from satisfactory with approximately 20 sustained viral response Extended use of lamivudine is associated with the emergence of drug resistance mutants As interferon is an immune modulator and lamivudine directly suppresses viral replication it is therefore logical to combine the 2 drugs for more efficient viral clearance
Previous studies on IFN-alfa and lamivudine combination treatment of chronic hepatitis B showed marginal benefit over lamivudine monotherapy In these studies lamivudine was either started 8 weeks prior to IFN-alfa or simultaneous with IFN-alfa Recently we have performed a study comparing the efficacy of polyethylene glycol-interferon alfa-2b PEG-Intron A and lamivudine versus lamivudine monotherapy for 1 year in the treatment of chronic hepatitis B In our protocol PEG-Intron A is started 8 weeks before the commencement of lamivudine and PEG-Intron A is given for 32 weeks while lamivudine is given for a total of 52 weeks Our published results suggested PEG-Intron A and lamivudine combination treatment is far superior to lamivudine monotherapy end of treatment virological response 92 vs 20 p00015 We are not certain whether the benefit of PEG-Intron A and lamivudine combination in our study is due to our staggered regime the superiority of PEG-Intron A over IFN-alfa or both The aim of this study is to investigate the best treatment regime of PEG-Intron A and lamivudine combination in terms of viral clearance
Previous studies on IFN-alfa and lamivudine combination treatment of chronic hepatitis B showed marginal benefit over lamivudine monotherapy In these studies lamivudine was either started 8 weeks prior to IFN-alfa or simultaneous with IFN-alfa Recently we have performed a study comparing the efficacy of polyethylene glycol-interferon alfa-2b PEG-Intron A and lamivudine versus lamivudine monotherapy for 1 year in the treatment of chronic hepatitis B In our protocol PEG-Intron A is started 8 weeks before the commencement of lamivudine and PEG-Intron A is given for 32 weeks while lamivudine is given for a total of 52 weeks Our published results suggested PEG-Intron A and lamivudine combination treatment is far superior to lamivudine monotherapy end of treatment virological response 92 vs 20 p00015 We are not certain whether the benefit of PEG-Intron A and lamivudine combination in our study is due to our staggered regime the superiority of PEG-Intron A over IFN-alfa or both The aim of this study is to investigate the best treatment regime of PEG-Intron A and lamivudine combination in terms of viral clearance
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