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Hepatitis B, Chronic clinical trials

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NCT ID: NCT00146705 Completed - Chronic Hepatitis B Clinical Trials

Long Term Follow-up of Pegylated-Interferon Alpha-2b

Start date: May 2005
Phase: N/A
Study type: Observational

The aim of this study was to investigate the long term outcome of Peginterferon alpha-2b with or without the addition of lamivudine in patients with chronic hepatitis B

NCT ID: NCT00142298 Completed - Chronic Hepatitis B Clinical Trials

Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies

Start date: March 2005
Phase: Phase 3
Study type: Interventional

This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.

NCT ID: NCT00140725 Completed - Chronic Hepatitis B Clinical Trials

Lamivudine Plus Interferon Versus Lamivudine For The Treatment Of HBeAg Positive Chronic Hepatitis B Virus (HBV)

Start date: April 2000
Phase: Phase 3
Study type: Interventional

This is a single-centre prospective randomised study comparing the virological and histological response of HBV infection to lamivudine in combination with interferon versus lamivudine alone.

NCT ID: NCT00132652 Completed - Chronic Hepatitis B Clinical Trials

Switching Therapy From Lamivudine to Telbivudine Versus Continued Lamivudine in Adults With Chronic Hepatitis B

Start date: February 2005
Phase: Phase 3
Study type: Interventional

This study is being conducted to compare the safety and effectiveness of switching treatment from lamivudine to telbivudine (LdT) against continued lamivudine treatment. Results from patients who were taking lamivudine and then switched to telbivudine will be compared with the results from patients who continued on lamivudine alone.

NCT ID: NCT00131742 Completed - Chronic Hepatitis B Clinical Trials

Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

Start date: July 2004
Phase: Phase 3
Study type: Interventional

This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.

NCT ID: NCT00128544 Completed - Hepatitis B Clinical Trials

Telbivudine Versus the Combination of Telbivudine and Valtorcitabine in Patients With Chronic Hepatitis B

Start date: May 2005
Phase: Phase 2
Study type: Interventional

This study is being conducted to compare the effectiveness of the combination of valtorcitabine and telbivudine to telbivudine alone in patients with chronic hepatitis B.

NCT ID: NCT00124241 Completed - Hepatitis B Clinical Trials

An Extension Study of Telbivudine, Lamivudine or Telbivudine Plus Lamivudine in Patients With Chronic Hepatitis B

Start date: n/a
Phase: Phase 2
Study type: Interventional

This is an extension study for patients who have previously completed Idenix Study NV-02B-003. This study is being conducted to compare the safety and effectiveness of treatment beyond 1 year of telbivudine and telbivudine combined with lamivudine, a drug currently approved for the treatment of hepatitis B.

NCT ID: NCT00120796 Terminated - Hepatitis B Clinical Trials

Lamivudine and Therapeutic Vaccine Evaluation in Senegalese Patients With Chronic Hepatitis B Infection (ANRS 12100 HEPADAK-2)

Start date: August 2005
Phase: Phase 3
Study type: Interventional

Chronic hepatitis B infection is a major public health issue in Senegal. The study will compare the efficacy of the treatment strategy combining Lamivudine and therapeutic vaccine (12 intra-muscular injections over a 6-month period) to a treatment with Lamivudine alone on the control of viral replication in patients with a replicative hepatitis B virus (HBV) infection and an increase in hepatic enzymes.

NCT ID: NCT00120354 Completed - Clinical trials for Hepatitis B, Chronic

Long-Term Lamivudine Therapy for Chronic Hepatitis B

Start date: July 11, 2005
Phase: Phase 4
Study type: Interventional

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 world's 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 1/16-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.

NCT ID: NCT00117676 Completed - Chronic Hepatitis B Clinical Trials

A Study to Compare Tenofovir Disoproxil Fumarate Versus Adefovir Dipivoxil for the Treatment of HBeAg-Negative Chronic Hepatitis B

Start date: February 2005
Phase: Phase 3
Study type: Interventional

This study is designed to evaluate the safety and antiviral activity of tenofovir disoproxil fumarate (TDF) compared to adefovir dipivoxil (ADV) for 48 weeks for the treatment of HBeAg-negative chronic hepatitis B. Subjects will either receive TDF or the approved hepatitis B therapy ADV. After 48 weeks all subjects will be switched to open-label TDF.