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Hepatitis, Chronic clinical trials

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NCT ID: NCT02011932 Active, not recruiting - Liver Cirrhosis Clinical Trials

Prospective Observational Study of Disease Progression in Chronic Hepatitis C

Start date: July 2010
Phase: N/A
Study type: Observational

The purpose of this study is to determine the progression of chronic hepatitis C patients infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease progression in chronic hepatitis C.

NCT ID: NCT01937806 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Phase 3 and Extensional Study of Besifovir

Start date: October 2013
Phase: Phase 3
Study type: Interventional

To prove that a study drug is noninferior to a control drug with a proportion of subjects who showed HBV DNA undetected (less than 400 copies/mL (69 IU/mL)) at the 48th week after 48-week administration of Besifovir 150 mg, or Tenofovir 300 mg as a control drug to chronic hepatitis B patients

NCT ID: NCT01872936 Active, not recruiting - Clinical trials for Hepatitis C, Chronic

Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection

Start date: June 2013
Phase: Phase 2
Study type: Interventional

The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.

NCT ID: NCT01834508 Active, not recruiting - Chronic Hepatitis B Clinical Trials

3E Extension Study

3E Ex
Start date: March 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.

NCT ID: NCT01833611 Active, not recruiting - Chronic Hepatitis Clinical Trials

Entecavir for Chronic Hepatitis B Patients With Persistently Normal ALT

Start date: September 2008
Phase: Phase 4
Study type: Interventional

Entecavir (ETV) has shown superior ability to suppress hepatitis B virus (HBV) replication, histology improvement as well as low rate of emergence of resistant mutants. Out of range of clinical recommendations for treatment of chronic hepatitis B (CHB), chronic HBV carriers with persistently normal ALT and viral load more than 10^5 copies/mL have progression of liver disease during long-term follow-up. In addition, certain proportions of these patients do have significant inflammation and fibrosis in liver histology. This study will be able to identify who are at risk of liver disease progression and evaluate efficacy of ETV regarding improvement of liver histology during short-term (1-year) and long-term ETV treatment (3-year).

NCT ID: NCT01829685 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

Dragon-Ex
Start date: March 2013
Phase: Phase 4
Study type: Interventional

The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy

NCT ID: NCT01821794 Active, not recruiting - Clinical trials for Chronic Hepatitis B e Antigen Positive

Tenofovir DF With or Without Peginterferon for Chronic Hepatitis B

Start date: March 2013
Phase: Phase 3
Study type: Interventional

Background: - There are two forms of chronic hepatitis B. The difference between the forms is whether or not a viral protein called hepatitis B e antigen is present in the blood. Standard approaches to treating both forms of chronic hepatitis B involve different drugs. One drug is called peginterferon, another is called tenofovir DF. These drugs are often given separately and used for different forms of the disease. However, researchers want to see if combining peginterferon and tenofovir DF will be a more effective treatment than tenofovir DF alone. Objectives: - To see whether combining tenofovir DF and peginterferon, or using tenofovir DF alone, is a more effective treatment of chronic hepatitis B. Eligibility: - Individuals at least 18 years of age who have chronic hepatitis B and are in the Hepatitis B Research Network Cohort study. Design: - Participants will be screened with a physical exam and medical history. Blood, urine, and liver tissue samples will be collected. Bone and liver imaging studies will also be performed. - Participants will be divided into two groups. One group will have tenofovir DF alone for 192 weeks (about 4 years). The other group will have tenofovir DF and peginterferon for 24 weeks (about 6 months), and then tenofovir DF alone for 168 weeks (about 3.5 years). - Participants will take the study drugs on the schedule determined by their study doctors. They will keep a diary to record their doses and any side effects. - Participants will have three study visits 4 weeks apart after the starting the treatment. At these visits, they will have a physical exam and provide blood samples. They may also provide urine samples and have imaging studies. - After the first three study visits, participants will continue to have study visits every 12 weeks until the treatment ends at week 192. These visits will have many of the same tests as the first three visits. At some of these visits, they may fill out questionnaires about their quality of life. - Participants who do not respond to the study drugs may have their medications changed. They may also be asked to stop treatment.

NCT ID: NCT01817725 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Effect of Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg—a Pilot Study

Start date: March 2013
Phase: Phase 1
Study type: Interventional

Background: The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance. There is a good chance to further increase the cure rate if the investigators can enhance the HBV-specific immune response when the HBsAg level already comes to a low level. Hypothesis: HBsAg-based vaccine can enhance HBsAg clearance in chronic hepatitis B patients whose HBsAg already <=2000 IU/ml. Patients and methods: This pilot study will enroll 20 chronic hepatitis B patients with HBsAg ≦2000 IU/ml, no hepatic decompensation, no HIV coinfection, nor clinical immunodeficiency. Engerix-B vaccine (20μg for <20 years old and 40 μg for ≥ 20 years old) will be given every 2 months for one year. HBsAg quantification, anti-HBs, and HBV DNA will be surveyed regularly before each dose during the treatment period and every 3 months for another year following the last dose. Viral and cellular factors will be studied to discover determinants affecting HBsAg clearance. Aims 1. To elucidate whether HBsAg-based vaccine can reactivate host immunity to eliminate chronic HBV infection in patients with low titer HBsAg. 2. To delineate the doses to response (HBsAg clearance or decline rate) correlation so as to design a feasible schedule for future clinical trials in a larger group of patients. 3. To discover viral and host factors which can be used as biomarkers for personalized vaccine therapy.

NCT ID: NCT01769833 Active, not recruiting - Chronic Hepatitis B Clinical Trials

HBsAg Decline After Pegylated-interferon-α in e Antigen Positive Chronic Hepatitis B With Nucleoside Maintenance

Start date: May 2013
Phase: Phase 3
Study type: Interventional

This study proposes to compare the effect of 48 weeks exposure to pegylated interferon alpha vs. nucleoside analogue (NA) on hepatitis B e antigen (HBeAg) seroconversion and HBsAg levels in nucleoside analogue controlled HBeAg-positive chronic hepatitis B (CHB) patients who have an undetectable hepatitis B virus (HBV) viral load at least 1 years.

NCT ID: NCT01743521 Active, not recruiting - Clinical trials for Early Chronic Hepatitis C

DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C)

DARE-C
Start date: January 2013
Phase: Phase 4
Study type: Interventional

To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin, Telaprevir) for the treatment of early chronic HCV infection.