Ignite Creation Date:
2024-05-05 @ 10:23 AM
Last Modification Date:
2024-10-26 @ 9:02 AM
Study NCT ID:
NCT00001457
Status:
COMPLETED
Last Update Posted:
2008-03-04
First Post:
1999-11-03
Brief Title:
Lamivudine for Chronic Hepatitis B
Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases NIDDK
Organization:
National Institutes of Health Clinical Center CC
Study Overview
Official Title:
Lamivudine for Chronic Hepatitis B
Status:
COMPLETED
Status Verified Date:
2005-09
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:
Chronic hepatitis B is a disease of the liver caused by the hepatitis B virus It affects nearly 1 million Americans Approximately 25 of patients with chronic hepatitis B will develop liver cirrhosis and 5 of patients will develop liver cancer
Presently two medications have been shown effective in the treatment of hepatitis B lamivudine and alpha interferon Alpha interferon an antiviral drug that acts through the immune system is given by injection once daily or three times a week for four to six months Lamivudine also known as 3-thiacytidine 3TC is an antiviral medication given as a pill once a day for twelve months These treatments have been known to provide long-term improvement in one third of patients receiving them
In previous research the drug lamivudine was shown to stop the growth of the hepatitis B virus and to lead marked decreases in the levels of hepatitis B virus and to improvements in the disease in 50 to 70 of patients However once lamivudine therapy was discontinued the virus returned to levels noted before the therapy began In those studies lamivudine was given for 3 to 12 months then discontinued This study will investigate the safety and effectiveness of long-term therapy with lamivudine
This study will select 60 patients diagnosed with hepatitis B After a thorough medical examination and liver biopsy subjects will be given lamivudine The drug will be taken by mouth in tablet form 100 mg once a day for up to 5 years Subjects will undergo regular check-ups and after 1 year of therapy be admitted to the Clinical Center for another medical examination and liver biopsy to assess progress Patients who have benefitted from the therapy will continue taking the medication for up to 5 years A third liver biopsy will be done during the last year of treatment The effectiveness of lamivudine will be determined by whether levels of hepatitis B virus decrease in the blood whether liver enzymes improve and whether inflammation and scarring decreases in the liver biopsies
Presently two medications have been shown effective in the treatment of hepatitis B lamivudine and alpha interferon Alpha interferon an antiviral drug that acts through the immune system is given by injection once daily or three times a week for four to six months Lamivudine also known as 3-thiacytidine 3TC is an antiviral medication given as a pill once a day for twelve months These treatments have been known to provide long-term improvement in one third of patients receiving them
In previous research the drug lamivudine was shown to stop the growth of the hepatitis B virus and to lead marked decreases in the levels of hepatitis B virus and to improvements in the disease in 50 to 70 of patients However once lamivudine therapy was discontinued the virus returned to levels noted before the therapy began In those studies lamivudine was given for 3 to 12 months then discontinued This study will investigate the safety and effectiveness of long-term therapy with lamivudine
This study will select 60 patients diagnosed with hepatitis B After a thorough medical examination and liver biopsy subjects will be given lamivudine The drug will be taken by mouth in tablet form 100 mg once a day for up to 5 years Subjects will undergo regular check-ups and after 1 year of therapy be admitted to the Clinical Center for another medical examination and liver biopsy to assess progress Patients who have benefitted from the therapy will continue taking the medication for up to 5 years A third liver biopsy will be done during the last year of treatment The effectiveness of lamivudine will be determined by whether levels of hepatitis B virus decrease in the blood whether liver enzymes improve and whether inflammation and scarring decreases in the liver biopsies
Detailed Description:
To assess the safety antiviral activity and clinical benefit of lamivudine 3-thiacytidine 3TC in chronic hepatitis B we will treat 60 patients with oral lamivudine in a dose of 100 mg daily for up to five years Lamivudine is a nucleoside analogue which is used extensively in patients with HIV infection and is being studied in controlled trials in chronic hepatitis B In this study we will evaluate lamivudine in patients with four different forms of chronic hepatitis B A Atypical serology HBeAg negative B extra-hepatic manifestations C chronic delta hepatitis D typical HBeAg- positive chronic hepatitis B After evaluation and liver biopsy patients will receive lamivudine 100 mg orally once daily for 1 year being monitored at regular intervals for symptoms of liver disease side effects of lamivudine serum biochemical and hematologic indices and serologic markers of hepatitis B and D virus replication At one year patients will have a repeat medical evaluation and liver biopsy If there is virologic biochemical or histologic evidence of benefit therapy will be continued thereafter for up to 5 years Patients who develop viral resistance to lamivudine may be offered therapy with higher doses of lamivudine 300 mg per day The activity of lamivudine will be assessed by changes in levels of HBV DNA or HDV RNA during treatment and its efficacy by loss of viral markers and improvements in aminotransferases and liver histology
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 95-DK-0199 | None | None | None |