Protocol Number: 01-DK-0246

Title:

Combination of Lamivudine and Adefovir Dipivoxil for Treatment of Chronic Hepatitis B

Number:

01-DK-0246

Summary:

This study will evaluate the safety and effectiveness of lamivudine plus adefovir versus adefovir alone to treat chronic hepatitis B infection. The Food and Drug Administration has approved lamivudine for the treatment of hepatitis B. However, the drug is not effective in all patients, and many of those in whom it initially works develop resistance after 1 to 3 years. Adefovir is an experimental drug that inhibits replication of the hepatitis B virus (HBV). Adefovir used alone may be adequate to provide sustained suppression of the virus and improvement in liver disease. However combining two anti-viral agents may be superior to using one alone, similar to the strategy employed for the treatment of AIDS. This study will test whether the combination of lamivudine and adefovir is better than adefovir alone for the treatment of chronic hepatitis B.

Patients 18 years of age and older, who have been infected with HBV for at least 6 months, may be eligible for this study. Candidates may not have received lamivudine treatment in the past 6 months or prior treatment with adefovir and must not be taking other anti-viral treatments for their hepatitis. They will have a blood test to confirm HBV infection.

Participants will be admitted to the NIH Clinical Center for 2 to 3 days for a medical evaluation, including a history and physical examination, blood and urine tests, 24-hour urine collection, chest X-ray, electrocardiogram (EKG), abdominal ultrasound and a liver biopsy if one has not been done within the last year. This procedure involves obtaining a small sample of liver tissue through a needle placed in the liver.

One to 2 weeks after the evaluation, patients will be randomized to begin taking 100 milligrams/day of lamivudine and 10 mg/day of adefovir, both in pill form or 10 mg of adefovir alone. Therapy will continue for at least 12 months. Follow-up clinic visits will be scheduled weekly for the first month, then every 4 to 8 weeks for the rest of the treatment period. The visits will involve a history and physical examination and blood tests. At the end of 1 year, patients will be evaluated in the Clinical Center with the same tests done at the beginning of the study. Patients who have not improved with treatment will stop taking the treatment and will be evaluated in the clinic once every 4 weeks for another 6 months. Patients who show an improvement in their liver injury may continue taking lamivudine and adefovir or adefovir alone for 4 more years, as long as they continue to improve with the medication. Progress will be evaluated with blood tests for HBV levels and liver enzymes. If the test results show no continued improvement or are negative for hepatitis B antigens, therapy will be stopped.

Patients who continue treatment for 5 years will be readmitted at year 4 to the Clinical Center for another medical evaluation and liver biopsy to assess the effects of treatment at that time. After the 5 years all patients will stop therapy at and be followed with regular clinic visits for at least 6 months.

Sponsoring Institute:

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Recruitment Detail

Type: No longer recruiting/follow-up only

Gender: Male & Female

Referral Letter Required: No

Population Exclusion(s): Children

Eligibility Criteria: This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Special Instructions:

Currently Not Provided

Keyword(s):

Adefovir Dipivoxil

Lamivudine

3TC

Nucleoside/Nucleotide Analogue

Chronic Hepatitis B

Hepatitis B Mutants

Liver Biopsy

Recruitment Keyword(s):

Hepatitis B

Hepatitis

HBV

Liver

Condition(s):

HBV

Hepatitis B

Hepatitis

Liver

Investigational Drug(s):

Adefovir Dipivoxil

Investigational Device(s):

None

Interventions:

Drug: Adefovir Dipivoxil

Supporting Site:

National Institute of Diabetes and Digestive and Kidney Diseases

Contact(s):

This study is not currently recruiting new subjects. If you have questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.

Citation(s):

Long-term follow-up of HBeAg-positive patients treated with interferon alfa for chronic hepatitis B

Chronic hepatitis B virus infection: treatment strategies for the next millennium

The treatment of chronic viral hepatitis

• Questions about participating in a study, please contact the Patient Recruitment and Public Liaison Office, CC.
• Technical questions regarding the Clinical Center web site, please contact the Department Clinical Research Informatics, CC.

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