Ignite Creation Date:
2024-05-05 @ 11:46 AM
Last Modification Date:
2024-10-26 @ 9:12 AM
Study NCT ID:
NCT00120354
Status:
COMPLETED
Last Update Posted:
2017-07-02
First Post:
2005-07-15
Brief Title:
Long-Term Lamivudine Therapy 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:
Long-Term Lamivudine Therapy for Chronic Hepatitis B
Status:
COMPLETED
Status Verified Date:
2007-03-31
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 will evaluate the long-term safety and effectiveness of lamivudine therapy and the possibility of stopping therapy in patients whose hepatitis B is chronic that is long lasting and which has responded to treatment Chronic hepatitis B caused by a virus is a common form of liver disease affecting about 1 million Americans and about 5 percent of the worlds population Health effects include a continuous state of being infectious and the risk of transmitting hepatitis to other people symptoms of liver disease and development of cirrhosis-that is severe damage to the liver-and liver cancer Lamivudine is a medication that blocks hepatitis B effectively but does not make it disappear completely Scientists believe that the immune system must also be active to rid the body of the last traces of hepatitis B
Patients ages 18 and older who have chronic hepatitis B and are being treated with lamivudine may be eligible to participate in this study They will undergo a medical history and physical examination and will be given lamivudine in 100 mg tablets to be taken as one tablet once each day Patients will be asked to return to the outpatient clinic every 3 months when they will undergo a brief interview and measurement of vital signs-such as blood pressure pulse and body weight During the visits they will fill out questionnaires about any symptoms or side effects they have and they will be seen by a doctor and have a brief medical history and examination There will be a collection of blood for complete blood counts liver enzymes and hepatitis B virus Extra blood tests may be done to analyze patients immune reactions to hepatitis B Patients will also receive refills of their lamivudine tablets They will continue to be treated with lamivudine as long as it seems to control the hepatitis infection and liver disease
At intervals of about 1 year patients will have ultrasound examinations lasting about 1 hour of the liver and abdomen Then at intervals of about 5 years patients will undergo liver biopsies which require a hospital stay of 2 to 3 days A liver biopsy is done by passing a needle through the skin into the liver to obtain a piece of liver about 2 inches long and 116-inch in diameter A small amount of bleeding probably occurs with most liver biopsies Internal bleeding is a risk which may require that the patient stay in the hospital a few days longer for rest observation and pain medicine The biopsy provides information that proves whether lamivudine is controlling the liver disease and preventing it from worsening or progressing to cirrhosis
Side effects of lamivudine include fatigue muscle aches fever and chills sore throat nausea stomach pain or cramps and diarrhea Serious side effects are rare occurring in less than 1 of people taking lamivudine They include inflammation of the pancreas nerve damage and buildup of lactic acid in the blood About 25 of patients experience a temporary worsening or flare of hepatitis during the first few months of treatment If flares are severe it is important for researchers to determine whether they are caused by resistance to lamivudine or by the immune system acting against the hepatitis B virus or another liver condition A flare of hepatitis can also occur when lamivudine is stopped that is a withdrawal In such situations testing for hepatitis B virus levels and other liver conditions is important It may lead to other treatments or stopping lamivudine and taking another medication instead While patients are participating in the study they will have a careful evaluation of their hepatitis and general condition They may have an improvement in their disease as a result of long-term lamivudine therapy
Patients ages 18 and older who have chronic hepatitis B and are being treated with lamivudine may be eligible to participate in this study They will undergo a medical history and physical examination and will be given lamivudine in 100 mg tablets to be taken as one tablet once each day Patients will be asked to return to the outpatient clinic every 3 months when they will undergo a brief interview and measurement of vital signs-such as blood pressure pulse and body weight During the visits they will fill out questionnaires about any symptoms or side effects they have and they will be seen by a doctor and have a brief medical history and examination There will be a collection of blood for complete blood counts liver enzymes and hepatitis B virus Extra blood tests may be done to analyze patients immune reactions to hepatitis B Patients will also receive refills of their lamivudine tablets They will continue to be treated with lamivudine as long as it seems to control the hepatitis infection and liver disease
At intervals of about 1 year patients will have ultrasound examinations lasting about 1 hour of the liver and abdomen Then at intervals of about 5 years patients will undergo liver biopsies which require a hospital stay of 2 to 3 days A liver biopsy is done by passing a needle through the skin into the liver to obtain a piece of liver about 2 inches long and 116-inch in diameter A small amount of bleeding probably occurs with most liver biopsies Internal bleeding is a risk which may require that the patient stay in the hospital a few days longer for rest observation and pain medicine The biopsy provides information that proves whether lamivudine is controlling the liver disease and preventing it from worsening or progressing to cirrhosis
Side effects of lamivudine include fatigue muscle aches fever and chills sore throat nausea stomach pain or cramps and diarrhea Serious side effects are rare occurring in less than 1 of people taking lamivudine They include inflammation of the pancreas nerve damage and buildup of lactic acid in the blood About 25 of patients experience a temporary worsening or flare of hepatitis during the first few months of treatment If flares are severe it is important for researchers to determine whether they are caused by resistance to lamivudine or by the immune system acting against the hepatitis B virus or another liver condition A flare of hepatitis can also occur when lamivudine is stopped that is a withdrawal In such situations testing for hepatitis B virus levels and other liver conditions is important It may lead to other treatments or stopping lamivudine and taking another medication instead While patients are participating in the study they will have a careful evaluation of their hepatitis and general condition They may have an improvement in their disease as a result of long-term lamivudine therapy
Detailed Description:
The major aims of this study are to evaluate the long-term efficacy and safety of lamivudine therapy and the possibility of stopping therapy in a cohort of patients with chronic hepatitis B who have a maintained response to treatment Lamivudine is a nucleoside analogue with potent activity against hepatitis B virus HBV which is approved for use in the United States and is used extensively throughout the world to treat HBV and HIV infection Lamivudine is well tolerated and adverse events are rare Its major shortcoming is the development of antiviral resistance after prolonged therapy which results in loss of effectiveness marked by rise in viral levels and return of disease activity Some patients however have a maintained response to lamivudine therapy and in these individuals treatment is continued indefinitely or until hepatitis B surface antigen HBsAg is lost and therapy can be permanently stopped This protocol will allow for the long-term treatment and evaluation of these patients Patients will be maintained on lamivudine at a dose of 100 mg daily and seen every three months for interim medical history and serum testing for aminotransferase levels and hepatitis B markers with liver biopsies done every 5 years Lamivudine will be stopped if HBsAg is lost The protocol also includes an option to attempt withdrawal of therapy under controlled conditions focusing on inducing immune reactivity to HBV and clearance of HBsAg Patients will stop lamivudine for short periods 1 week and later for 2 4 and 8 weeks and be monitored during and for 12 weeks afterwards for aminotransferase levels HBV DNA levels and CD4 and CD8 T cell responses to HBV antigens Patients who demonstrate significant worsening of hepatitis will not undergo further attempts at withdrawal The endpoint to successful therapy is defined as loss of hepatitis B surface antigen HBsAg and development of antibody anti-HBs
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 |
|---|---|---|---|
| 05-DK-0195 | None | None | None |