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Hepatitis clinical trials

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NCT ID: NCT01610115 Recruiting - Pregnancy Clinical Trials

HBV DNA Levels During Pregnancy in Chronic Hepatitis B

Start date: January 2012
Phase: N/A
Study type: Observational

To elucidate the natural course of chronic hepatitis B by serial HBV DNA and alanine aminotransferase (ALT) levels during pregnancy

NCT ID: NCT01607021 Recruiting - Chronic Hepatitis C Clinical Trials

Pharmacogenomics Study on IL28B Genetic Variants in Chinese Children With Hepatitis C Virus Infection

Start date: April 2012
Phase: N/A
Study type: Observational

The aim of this study is to investigate the relationships between interleukin 28B genetic variants and the response to treatment of chronic hepatitis C in Chinese children.

NCT ID: NCT01603108 Recruiting - Hepatitis C Clinical Trials

Rifaximin to Prevent Recurrent HCV-Related Fibrosis After Liver Transplant

Rifaximin
Start date: March 2012
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if the administration of a poorly-absorbable antibiotic (rifaximin) for the first three months after liver transplant will reduce the amount of fibrosis (or scarring of the liver) in liver transplant patients with recurrent hepatitis C virus (HCV) by lowering serum lipopolysaccharide (LPS), a protein in blood that comes from the bacteria in intestines and may cause scarring in the liver. Approximately 60 subjects will participate in this study. Subjects will be part of the study for approximately 1 year post transplant.

NCT ID: NCT01595633 Recruiting - Chronic Hepatitis B Clinical Trials

Switch From Adefovir to Tenofovir in Chronic Hepatitis B for Suboptimal Response to Adefovir-based Combination Therapy

Start date: March 2012
Phase: Phase 4
Study type: Interventional

In Korea, the number of suboptimal responders to rescue combination therapy is also increasing. As a matter of fact, according to the investigations in Korea, HBV DNA undetectability at 48 weeks of adefovir and lamivudine combination rescue therapy for patients with lamivudine resistance was reported to be only 32.4%, which suggested that the appropriate another rescue therapy might be urgently required. However, there is no promising oral antiviral agents to control these patients in Asia-Pacific region, where tenofovir is not widely available. Tenofovir has a higher potent antiviral efficacy and a negligible drug resistance rate. The switch from adefovir to tenofovir in patients who have insufficient hepatitis B virus (HBV) suppression (HBV DNA ≥ 60 IU/mL by PCR) may lead to increased viral suppression or more HBeAg loss/seroconversion. Here, the investigators aimed to conduct a randomized study on evaluating the antiviral efficacy, safety, and tolerability of switching from adefovir to tenofovir in chronic hepatitis B patients who have suboptimal response to adefovir-based combination rescue therapy due to nucleoside analogues Resistance (SATIS study).

NCT ID: NCT01590381 Recruiting - Hepatitis b Vaccine Clinical Trials

Assessment of HBV Vaccine Immunity After 18 Years

Start date: December 2011
Phase: N/A
Study type: Observational

The purpose of this study is to assess HBV immunity and institute policy regarding the Hepatitis B vaccination practices in the IDF among a cohort that was vaccinated during infancy.

NCT ID: NCT01589952 Recruiting - Chronic Hepatitis B Clinical Trials

Pegylated Interferon and Entecavir Combination in Chronic Hepatitis B (CHB)

Bangabandhu
Start date: March 2012
Phase: Phase 1/Phase 2
Study type: Interventional

According to published literature, treatment with pegylated interferon (Peg-IFN) is associated with end of treatment response in treatment naive patients with chronic hepatitis B (CHB). It has antiviral as well as anti-fibrotic properties and treatment with Peg-IFN results in improvement of liver histology and down regulation of progression to cirrhosis of liver. Peg-IFN is administered for a finite duration. The major limitation of Peg-IFN is that only 30-49% patients are benefited by this anti-viral drug. Another potent anti-viral drug, entecavir (ETV), on the other hand, reduces HBV replication in most patients, but causes improvement of liver histology in only 30%, possibly because of its lack of immune modulatory ability like Peg-IFN. Also, ETV treatment is associated with several complications like emergence of HBV mutant. The aim of this study is to assess whether the combination of these two 'unique' anti-viral drugs offer the best possible outcome to treatment-naïve CHB patients, in terms of treatment response (virological and biochemical), treatment cost and duration and adverse events.

NCT ID: NCT01588912 Recruiting - Chronic Hepatitis B Clinical Trials

Efficacy of Telbivudine With or Without add-on Tenofovir According to Roadmap Strategy Compare With Entecavir

TETRA
Start date: April 2012
Phase: Phase 4
Study type: Interventional

Oral antiviral drugs which can be given to patients with HBeAg-positive chronic hepatitis B include Lamivudine, Clevudine, Adefovir, Telbivudine, Entecavir and Tenofovir. 2009 American Association for the Study of Liver Disease (AASLD) Treatment Guidelines and 2009 European association for the Study of the Liver (EASL) Treatment Guidelines recommend the administration of Entecavir or Tenofovir with high potency and low resistance. Lamivudine has low antiviral potency and high incidence of mutation in long-term administration compared to Entecavir or Tenofovir. Clevudine causes the elevated creatinine kinase (CK), side effects including myositis/myopathy and much mutation in the long-term administration. Globe study demonstrated Telbivudine had more excellent antiviral potency than Lamivudine, which was also comparable to or higher than Entecavir or Tenofovir. Nevertheless, the choice of treatment drugs can be limited due to the mutation rate of 25% for 2 years. However, the analysis of Globe study results showed that 2-year treatment progress was very good in patient who showed virologic response at 24 weeks after the initiation of treatment and that high antiviral potency and low mutation rate were observed when the Telbivudine roadmap strategy (in the event that virologic response is shown at 24 weeks, telbivudine monotherapy is maintained and in the event that virologic response is not shown, tenofovir add-on therapy is done) recently implemented and announced in 2011 Asian Pacific Association for the Study of the Liver (APASL) was applied. However, the study was single arm study, which restricted the comparison between Entecavir and Tenofovir monotherapy groups. Therefore, this study intends to compare the anti-viral effect and mutation rate between Entecavir 0.5mg monotherapy group and Telbivudine roadmap strategy group in patients with HBeAg-positive chronic hepatitis B through a randomized study.

NCT ID: NCT01572233 Recruiting - Clinical trials for Hepatitis C Virus Infection, Response to Therapy of

Effects of Activity and Education Program on Patients With Chronic Hepatitis C Infection

Start date: December 2011
Phase: N/A
Study type: Interventional

This 4-year project will be guided by a biobehavioral model for the study of exercise interventions in two phases with the purposes to : 1. explore the patients' physical activity preferences and develop doable activity lists during treatment period 2. examine the changes of health-related physical fitness component over interferon treatment 3. develop the Personalized Physical Activity and Psych-Education (PPAPE) Program and test its effects on decreasing fatigue, physical and psychological distress, and improving their health-related physical fitness and quality of life in patients with chronic hepatitis C receiving Interferon with Ribavirin Combination Therapy 4. evaluate the outcome of the PPAPE program on increasing adherence to therapy, the sustained virological response (SVR) in 24 weeks after the end of treatment, and the time-consuming for education program during intervention.

NCT ID: NCT01533051 Recruiting - Chronic Hepatitis B Clinical Trials

Prospective Observational Cohort Study for the Durability of Anti-viral Therapy in Patients With Chronic Hepatitis B

Start date: February 2012
Phase: N/A
Study type: Observational

The aim of this study is to investigate the off-treatment sustained virological and biochemical response in chronic hepatitis B patients following the guideline by the Asian Pacific Association for the Study of the Liver (APASL) in Korea.

NCT ID: NCT01491295 Recruiting - Chronic Hepatitis B Clinical Trials

Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients

Start date: September 2012
Phase: Phase 4
Study type: Interventional

1. Adefovir add-on therapy is superior to switching to adefovir monotherapy or entecavir 1mg monotherapy for chronic hepatitis B (CHB) patients with lamivudine resistance (LAM-R) 2. Long-term adefovir add-on therapy was effective for viral suppression. However, the economic burden for such dual antiviral therapy is heavy because of infinite treatment. 3. Tenofovir disoproxil fumarate (TDF) is a potent antiviral agent. TDF demonstrated potent antiviral efficacy in a subset of lamivudine experienced HBeAg-positive patients. TDF is also superior to ADV in HBeAg-negative and HBeAg-positive treatment-naive patients. 4. Theoretically, TDF can replace LAM/ADV when viral suppression has been achieved by LAM/ADV combination treatment in LAM-R CHB patients.