Ignite Creation Date:
2024-05-05 @ 4:35 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00275938
Status:
COMPLETED
Last Update Posted:
2006-01-12
First Post:
2006-01-11
Brief Title:
Interferon Alpha 2b Plus Ribavirin for Chronic Hepatitis B
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Pilot Study Of Interferon Alpha 2b Plus Ribavirin In The Treatment Of Patients With Chronic Hepatitis B
Status:
COMPLETED
Status Verified Date:
2006-01
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:
Hepatitis B virus HBV causes a wide spectrum of liver diseases such as fulminant or acute hepatitis chronic hepatitis liver cirrhosis and hepatocellular carcinoma The number of individuals infected with this virus has been estimated to be as high as 350 million Thus in addition to global hepatitis B vaccination effective treatment of chronic hepatitis B is also needed
Currently there are no effective antiviral treatments to cure HBV infection in patients with chronic hepatitis B Five drugs have been approved for the treatment of chronic hepatitis B at present conventional interferon IFN alpha lamivudine adefovir dipivoxil pegylated IFN alpha and recently entecavir Overall satisfactory virologic and serologic responses could be achieved using pegylated IFN alpha alone in around 20-44 of these patients Nevertheless better treatment options are still needed for the remaining 50 non-responders
Although the best treatment choice for chronic hepatitis B is not clarified yet certain therapeutic concepts could be derived from the experience of treating patients with chronic hepatitis C A major advancement in treating hepatitis C virus HCV infection has been the development of combination therapy with IFN and ribavirin IFN monotherapy is limited by poor sustained virologic responses even when higher doses of IFN are used IFN plus ribavirin combination therapy in contrast results in much improved treatment outcomes In our previous study and others sustained remission rate after cessation of therapy were significantly higher in patients receiving combination therapy than those receiving IFN alone Therefore combination therapy with IFN and ribavirin has been recommended as the standard treatment regimen for chronic hepatitis C Furthermore we have used ribavirin and IFN combination for the treatment of dual chronic hepatitis B and C and the results also revealed that the efficacy of clearing HCV RNA was not affected by the presence of HBV infection Interestingly after a little more than 2-year post-treatment follow-up we found that a significant portion 21 of the responsive patients also cleared HBsAg These findings imply that this combination regimen might be also effective for the control of chronic hepatitis B We thus conducted a randomized multi-center placebo-controlled study in patients with HBeAg-positive chronic hepatitis B
Currently there are no effective antiviral treatments to cure HBV infection in patients with chronic hepatitis B Five drugs have been approved for the treatment of chronic hepatitis B at present conventional interferon IFN alpha lamivudine adefovir dipivoxil pegylated IFN alpha and recently entecavir Overall satisfactory virologic and serologic responses could be achieved using pegylated IFN alpha alone in around 20-44 of these patients Nevertheless better treatment options are still needed for the remaining 50 non-responders
Although the best treatment choice for chronic hepatitis B is not clarified yet certain therapeutic concepts could be derived from the experience of treating patients with chronic hepatitis C A major advancement in treating hepatitis C virus HCV infection has been the development of combination therapy with IFN and ribavirin IFN monotherapy is limited by poor sustained virologic responses even when higher doses of IFN are used IFN plus ribavirin combination therapy in contrast results in much improved treatment outcomes In our previous study and others sustained remission rate after cessation of therapy were significantly higher in patients receiving combination therapy than those receiving IFN alone Therefore combination therapy with IFN and ribavirin has been recommended as the standard treatment regimen for chronic hepatitis C Furthermore we have used ribavirin and IFN combination for the treatment of dual chronic hepatitis B and C and the results also revealed that the efficacy of clearing HCV RNA was not affected by the presence of HBV infection Interestingly after a little more than 2-year post-treatment follow-up we found that a significant portion 21 of the responsive patients also cleared HBsAg These findings imply that this combination regimen might be also effective for the control of chronic hepatitis B We thus conducted a randomized multi-center placebo-controlled study in patients with HBeAg-positive chronic hepatitis B
Detailed Description:
Hepatitis B virus HBV causes a wide spectrum of liver diseases such as fulminant or acute hepatitis chronic hepatitis liver cirrhosis and hepatocellular carcinoma The number of individuals infected with this virus has been estimated to be as high as 350 million Thus in addition to global hepatitis B vaccination effective treatment of chronic hepatitis B is also needed
Currently there are no effective antiviral treatments to cure HBV infection in patients with chronic hepatitis B Five drugs have been approved for the treatment of chronic hepatitis B at present conventional interferon IFN alpha lamivudine adefovir dipivoxil pegylated IFN alpha and recently entecavir Conventional IFN alpha monotherapy has a narrow range of efficacy Lamivudine is relatively cheaper better tolerated and has been shown to be effective in patients with both hepatitis B e antigen HBeAg-positive and -negative chronic hepatitis B However virologic response to lamivudine is not as durable as that occurred spontaneously or induced by IFN treatment In addition prolonged lamivudine treatment is commonly associated with the emergence of drug-resistance HBV mutants accompanied by the development of breakthrough hepatitis Adefovir is potent and has been approved for the treatment of chronic hepatitis B in several countries but is nephrotoxic at daily doses higher than 10 mg and is still not available widely Entecavir a carbocyclic deoxyguanosine analog which is active against both lamivudine- and adefovir dipivoxil-resistant HBV is the most potent anti-HBV agent ever discovered11 however its long-term efficacy remains to be evaluated Pegylated IFN alpha has recently been shown to be superior to conventional IFN alpha and lamivudine and has also been approved for the treatment of chronic hepatitis B Overall satisfactory virologic and serologic responses could be achieved using pegylated IFN alpha alone in around 30-44 of these patients Nevertheless better treatment options are still needed for the remaining 50 non-responders
Although the best treatment choice for chronic hepatitis B is not clarified yet certain therapeutic concepts could be derived from the experience of treating patients with chronic hepatitis C A major advancement in treating hepatitis C virus HCV infection has been the development of combination therapy with IFN and ribavirin IFN monotherapy is limited by poor sustained virologic responses even when higher doses of IFN are used IFN plus ribavirin combination therapy in contrast results in much improved treatment outcomes In our previous study and others sustained remission rate after cessation of therapy were significantly higher in patients receiving combination therapy than those receiving IFN alone Therefore combination therapy with IFN and ribavirin has been recommended as the standard treatment regimen for chronic hepatitis C Furthermore we have used ribavirin and IFN combination for the treatment of dual chronic hepatitis B and C and the results also revealed that the efficacy of clearing HCV RNA was not affected by the presence of HBV infection Interestingly after a little more than 2-year post-treatment follow-up we found that a significant portion 21 of the responsive patients also cleared HBsAg These findings imply that this combination regimen might be also effective for the control of chronic hepatitis B We thus conducted a randomized multi-center placebo-controlled study in patients with HBeAg-positive chronic hepatitis B
Currently there are no effective antiviral treatments to cure HBV infection in patients with chronic hepatitis B Five drugs have been approved for the treatment of chronic hepatitis B at present conventional interferon IFN alpha lamivudine adefovir dipivoxil pegylated IFN alpha and recently entecavir Conventional IFN alpha monotherapy has a narrow range of efficacy Lamivudine is relatively cheaper better tolerated and has been shown to be effective in patients with both hepatitis B e antigen HBeAg-positive and -negative chronic hepatitis B However virologic response to lamivudine is not as durable as that occurred spontaneously or induced by IFN treatment In addition prolonged lamivudine treatment is commonly associated with the emergence of drug-resistance HBV mutants accompanied by the development of breakthrough hepatitis Adefovir is potent and has been approved for the treatment of chronic hepatitis B in several countries but is nephrotoxic at daily doses higher than 10 mg and is still not available widely Entecavir a carbocyclic deoxyguanosine analog which is active against both lamivudine- and adefovir dipivoxil-resistant HBV is the most potent anti-HBV agent ever discovered11 however its long-term efficacy remains to be evaluated Pegylated IFN alpha has recently been shown to be superior to conventional IFN alpha and lamivudine and has also been approved for the treatment of chronic hepatitis B Overall satisfactory virologic and serologic responses could be achieved using pegylated IFN alpha alone in around 30-44 of these patients Nevertheless better treatment options are still needed for the remaining 50 non-responders
Although the best treatment choice for chronic hepatitis B is not clarified yet certain therapeutic concepts could be derived from the experience of treating patients with chronic hepatitis C A major advancement in treating hepatitis C virus HCV infection has been the development of combination therapy with IFN and ribavirin IFN monotherapy is limited by poor sustained virologic responses even when higher doses of IFN are used IFN plus ribavirin combination therapy in contrast results in much improved treatment outcomes In our previous study and others sustained remission rate after cessation of therapy were significantly higher in patients receiving combination therapy than those receiving IFN alone Therefore combination therapy with IFN and ribavirin has been recommended as the standard treatment regimen for chronic hepatitis C Furthermore we have used ribavirin and IFN combination for the treatment of dual chronic hepatitis B and C and the results also revealed that the efficacy of clearing HCV RNA was not affected by the presence of HBV infection Interestingly after a little more than 2-year post-treatment follow-up we found that a significant portion 21 of the responsive patients also cleared HBsAg These findings imply that this combination regimen might be also effective for the control of chronic hepatitis B We thus conducted a randomized multi-center placebo-controlled study in patients with HBeAg-positive chronic hepatitis B
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