Active clinical trials for "Hepatitis, Chronic"

Objectives: Primary To evaluate the safety, tolerability, and efficacy of Peginterferon a-2a plus Ribavirin for the treatment of chronic hepatitis C (CHC) infection in persons co-infected with human immunodeficiency virus (HIV) who have failed to achieve a sustained virologic response following previous interferon therapy. Secondary To evaluate the virological response to Peginterferon a-2a plus Ribavirin at weeks 12 and 24 as compared to baseline values. To evaluate the sustained virological response Peginterferon a-2a plus Ribavirin at post-treatment weeks 4, 12, and 24 as compared to baseline. To evaluate the histological effects of long-term Peginterferon a-2a therapy through comparison of liver biopsy results following 96 weeks of Peginterferon a-2a therapy to baseline values. To evaluate the safety and tolerability of long-term Peginterferon a-2a therapy in patients who have previously failed to achieve a sustained virologic response following interferon therapy. To investigate the effects of long-term Peginterferon a-2a therapy on clinical outcomes of HIV disease. Study Design: All qualifying patients will enter the treatment phase and be dosed as follows: Peginterferon a-2a 180mg by subcutaneous route once weekly plus Ribavirin: 800 mg (400 mg bid) if body weight < 65 kg 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg 1200 mg (600 mg bid) if body weight > 85 kg Patients with undetectable levels of HCV-RNA at Treatment Week 24 will continue on previously assigned Peginterferon a-2a plus Ribavirin combo-therapy for an additional 24 weeks. Patients with detectable levels of HCV-RNA will be randomized to Peginterferon a-2a mono-therapy or no treatment for 72 weeks. Group A: Peginterferon a-2a 90mg mono-therapy for 72 weeks. Group B: No CHC therapy for 72 weeks All patients entering the study are required to have a baseline liver biopsy (within 18 months of study entry). Patients entering the 72-week randomized arm of the trial will have a post-study liver biopsy upon completion of the trial. Study Population: 100 HIV infected adults with chronic hepatitis C infection who have failed to achieve a sustained virologic response following previous interferon therapy. Dosage and Administration: Combo-therapy: Peginterferon a-2a 180mg by subcutaneous route once weekly plus Ribavirin: 800 mg (400 mg bid) if body weight < 65 kg 1000 mg (400 mg a.m. and 600 mg p.m.) if body weight > 65 kg and < 85 kg 1200 mg (600 mg bid) if body weight > 85 kg Mono-therapy: Peginterferon a-2a 90mg in 1mL solution administered subcutaneously once weekly. Efficacy Evaluations: Laboratory analysis, liver biopsies, quality of life assessments, and changes in Peginterferona-2a and Ribavirin dosages will be obtained. Safety Evaluations: Assessment of laboratory evaluations vital signs incidence and severity of adverse experiences dose adjustments premature withdrawal for safety reasons progression of disease as measured by HCV viral load AIDS defining events

This is an open label, randomized, multi-center, comparative study. Subjects will be screened prior to study entry to establish eligibility. 60 Subjects who meet all the selection criteria will be randomly assigned to (A) QL007 200mg BID+ Tenofovir dipirofurate fumarate （TDF）300 mg QD, (B) QL007 200 mg BID+ Entecavir 0.5 mg QD, (C)TDF 300 mg QD, (D) Entecavir 0.5 mg QD. The purpose of this study was to evaluate the efficacy and safety of QL-007 tables in combination with TDF or Entecavir in patients with chronic hepatitis b who have received nucleoside (acid) therapy, and to recommend a reasonable regimen for phase III study.

Chronic HBV infection is major problem in Asian countries. Years after chronic infection, in some cases serum HBsAg level declines to unmeasurable level. Some of patients develop anti-HBsAb but there is no standard treatment to accelerate HBsAg seroconversion. There is a study to determine efficacy and safety of HBV vaccine in who is Chronic HBV infection and lost their HBsAg without seroconversion to anti-HBsAb.

Entecavir 1 mg is commonly used in patients with chronic hepatitis B (CHB) patients with previous antiviral resistance. This study evaluates the efficacy and safety of switching to generic entecavir 1 mg (Baracle®, Dong-A Science Technology) in CHB patients taking brand name entecavir 1 mg (Baraclude®, Bristol-Myers Squibb) alone or in combination with other nucleos(t)ide analogues after the development of antiviral resistance. The primary aim is virological response (<20 IU/mL) at 12 months

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, CD4+T Cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD4+T Cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg IFN - alpha suppressed the virus and the reduction of virus led to the recovery of CD4+T Cells function, or Peg IFN - alpha enhanced CD4+T Cells function which gave rise to the decline of the virus.

Pegylated interferon α-2a(Peg-IFN-α) not only inhibit viral replication, but also play an important role in immune regulation, while Nucleoside analog(ue) drugs only inhibit viral replication. In hepatitis B infection, CD8+T cells are the main effector cells in adaptive immune response. This study was aimed at investigating the changes of CD8+T cells frequency and function, and the expression of costimulatory molecules during Peg-IFN-αand nucleoside analog(ue) therapy.Meanwhile, the investigators want to verify whether Peg-IFN-α suppressed the virus and the reduction of virus led to the recovery of CD8+T cells function, or Peg IFN - alpha enhanced CD8+T cells function which gave rise to the decline of the virus.

The clinical study determines the effect of Evogliptin in patients with type 2 diabetes mellitus and chronic hepatitis B to confirm the improvement of hepatic fibrosis.

The study is to observe the anti-HBV therapeutic effects of peginterferon alfa-2b in chronic hepatitis b patients with e antigen positive based on the detection of interferon gene mutation (IFNA2 p.Ala120Thr) and interferon receptor (IFNAR2) detection.

Chronic hepatitis C virus infection affects an estimated one hundred and seventy million people around the world with and approximate prevalence 0.2-2 % in the United State of America and European countries.

Chronic Hepatitis B carriers (normal LFTs and viral load < 2 x 10^4 IU/ml are not recommended to be treated by guidelines as they are at low risk for complications. However, it is unclear if treatment can enhance HBsAg loss which has been shown to be associated with significantly lower risk of complications compared to those without HBsAg loss. Consequently, this is a proof of concept study to determine the possibility of HBsAg loss in Chronic Hepatitis B carriers in a randomised open label clinical trial comparing no treatment to 24 weeks peg-interferon alpha 2a or 48 weeks peginterferon alpha 2a (randomised 1:1:1). The primary endpoint of HBsAg loss will be evaluated 24 weeks after the end of therapy for those on therapy and matched to an equivalent timepoint in the control arm. The sample size calculation is 30 patients in each arm for a 20% difference between any experimental arm and the control arm.