View clinical trials related to Hepatitis, Chronic.
Filter by:The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic hepatitis B virus (HBV) infection. The optimal treatment for adolescents with chronic HBV infection is currently unknown. Treatment with interferon alfa, lamivudine, and adefovir dipivoxil in pediatric populations has been shown to be less than optimal. Further, the safety and efficacy of entecavir and telbivudine have not been established in patients < 16 years of age. A study evaluating TDF in adolescents (ages 12-17) was needed to assess the safety and efficacy of this agent in the treatment of chronic hepatitis B in this patient population. In addition, the study will help to further elucidate the pharmacokinetic (PK) and resistance profiles of TDF. Through their participation, study participants will help generate critical new information to help guide the most optimal treatment of chronic HBV infection in adolescents. This is a randomized, double-blind study to evaluate the antiviral efficacy, safety, and tolerability of TDF versus placebo in adolescents with chronic HBV infection. One hundred TDF treatment-naive participants were randomized in a 1:1 ratio to TDF or placebo. After 72 weeks of blinded treatment, all participants were to switch to open-label TDF for an additional 2.5 years of treatment, provided that no safety concerns are identified by the Independent Data Monitoring Committee monitoring the study.
The objective of the study is to assess the safety and efficacy of PegIntron injector and Rebetol administered to participants with chronic hepatitis C. Participants will be treated by general practitioners in clinical practice as part of the post-marketing surveillance study. The study will assess the rates of eradication of the hepatits C virus and the rates of serious adverse events reported with PegIntron (1.5 μg/kg/week) and Rebetol (800-1200 mg/day) in common medical practice in Germany.
Although injection drug users represent the majority of new and existing cases of infection with hepatitis C virus (HCV), many lack access to treatment because of concerns about adherence, effectiveness, and reinfection. On the basis of a small but growing body of evidence showing that injection drug users can undergo treatment for HCV infection successfully, the 2002 NIH Consensus Statement on Hepatitis C has recommended that substance users be treated for HCV infection on a case-by-case basis. In this study, all patients will receive pegylated interferon alfa-2b (PegIFN-2b) and ribavirin according to European labeling; one cohort of participants will also be receiving substitution therapy (opioid medicines with long-lasting effects [methadone + buprenorphine] or morphine).
Participants will receive PegIntron injection pen (Peginterferon alfa-2b) and Rebetol (Ribavirin) combination therapy as their usual medical treatment. The current study aims to evaluate whether the previously introduced, and now widely accepted and implemented educational program, which represents additional efforts in everyday practice to increase patient compliance, will succeed in achieving adherence rate in treated participants similar to the extent demonstrated by clinical trials.
This study will evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of albinterferon alfa 2b (alb-IFN) single dose in Japanese chronic hepatitis C patients
This study aims to evaluate the efficacy and safety of peginterferon alfa-2b plus weight-based ribavirin as initial treatment in chronic hepatitis C virus (HCV) genotype 1 patients. All patients will receive peginterferon alfa-2b plus oral ribavirin for 12 weeks. At the end of this period, quantitative PCR will be used to determine the Early Viral Response (EVR) at this point of treatment. Total treatment duration will be 48 weeks for Early Responders, 72 weeks for Slow Responders, and 12 weeks for Nonresponders.
This is a post-marketing surveillance of patients with chronic hepatitis C treated with PegIntron and Rebetol combination therapy in clinical practice in Japan. The objective of the study is to evaluate the safety and efficacy of the combination therapy. The study will also compare the safety profile of the combination therapy among elderly patients and younger patients. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
The objective of the study is to evaluate the safety and efficacy of PegIntron plus Rebetol combination therapy administered to patients with chronic hepatitis C. The study will exclude (1) subjects with HCV genotype 1 and high viral load, and (2) interferon-naïve subjects with low viral load. It is being conducted as a post-approval commitment, in accordance with the Ministry of Health, Labour and Welfare's guideline on Good Post-marketing Study Practice. Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.
The objective of the study is to evaluate the costs associated with peginterferon alfa-2b (PegIntron) plus ribavirin (Rebetol) treatment for chronic hepatitis C in the Czech Republic. Only costs associated with rescue medication, concomitant therapy, disease monitoring, and medical intervention costs recognized by the treating institution as treatment-related expenses will be included in the analysis. The study will also evaluate the correlation between hepatitis C virus (HCV) therapy-related costs with ribavirin dosing and participant history.
The role of the dendritic cells, the most potent antigen presenting cells, in the establishment of chronic hepatitis C is not established. The study aims to define whether the dendritic cells are affected by the hepatitis C virus and whether that bears an impact on the antiviral immune response they generate. The hypothesis is explored by investigating a group of patients prior to and after the initiation of standard treatment for hepatitis C with pegylated Interferon and Ribavirin.