Active clinical trials for "Hepatitis C, Chronic"

This observational long-term follow-up study will assess the persistence of direct acting antiviral (DAA) resistant mutations and the durability of sustained virological response in patients with chronic hepatitis C who have participated in a Roche DAA treatment protocol. Up to 5 scheduled monitoring visits for blood sampling during an observational period of up to 36 months.

The purpose of this study is to evaluate the antiviral efficacy of Boceprevir-based therapy for the treatment of genotype 6 chronic hepatitis C infection. Boceprevir has recently been approved for the treatment of genotype 1 chronic hepatitis C infection. Recent in vitro studies suggest similar efficacy against genotype 6 chronic hepatitis C infection. The investigators therefore hypothesise that: i) Boceprevir is a potent inhibitor of genotype 6 hepatitis C replication in vivo. ii) Boceprevir in combination with pegylated interferon-alpha and ribavirin for 24 weeks will cure a high proportion of patients chronically infected with genotype 6 chronic hepatitis C infection.

We perform this study to identity efficacy and safety of Daclatasvir and Asunaprevir in real practice.

The objective of the study is to assess the safety and efficacy of Intron A (3 Mio I.E./m2, 3 times per week) and Rebetol (15 mg/kg/day) in children aged 3 to 17, treated in common medical practice at 10 sites in Germany. The primary objective is to determine if there are any new severe adverse events observed with this recently approved dosing regimen. The study will also evaluate the rates of eradication of the HCV virus. This study was terminated due to low enrollment. At the time of termination, 3 participants had enrolled. Therefore, these 3 participants transferred into study P04538 (NCT00727077) and will be included in the P04538 (NCT00727077) data reporting.

Pegylated interferon in combination with ribavirin is the current standard treatment of chronic hepatitis C virus infection, but is expensive and has several adverse effects. To modify this standard treatment by optimizing its therapeutic effect and decreasing its adverse events are important. Recent studies have identified a close link between metabolic profiles, insulin resistance and Hepatitis C Virus (HCV) infection. Several pilot studies in western world have have found beneficial effects of oral hypoglycemic agents on chronic Hepatitis C (CHC) genotype 1 infected patients. Whether this concept still holds true in Taiwanese people remains unknown. The objective of this clinical trial is to evaluate the effect of oral hypoglycemic agents (daily for 4 weeks of run-in period and 8 weeks of combination treatment) on CHC genotype 1 infected Taiwanese patients receiving 48 weeks of Peg-IFN plus ribavirin (RBA), and the enrolled subjects will be randomized into 4 treatment groups (including Acarbose, Metformin, Pioglitazone and standard care control groups). During the trial and 24 weeks after the end of treatment, serial serum HCV RNA, alanine aminotransferase (ALT) levels, and other clinical data will be evaluated to determine the therapeutic response and adverse events of the CHC patients.

A Phase II, Open Label, Multi-Center, Proof-Of-Concept Study determing whether treatment with HDV-Interferon (HDV-IFN), by oral or subcutaneous (injection) routes, and ribavirin results in similar efficacy [Rapid Virologic Response (RVR)] and safety as the reported efficacy and safety with pegylated alpha-interferon-2a and ribavirin (historical control) in patients with chronic hepatitis C (treatment naïve by oral route and non-responders by SC route respectively).

This is a phase I clinical study to evaluate feasibility, safety and kinetics of cellular therapy with autologous bone marrow-derived mononuclear cells (BMMC) in patients with liver cirrhosis due to virus C hepatitis. Another aim is to study liver tissue changes induced by the BMMC presence. All the patients have moderate liver disfunction and will be submitted to a liver biopsy before BMMC injection. The cells will be labeled with 99mTc and infused through a peripheral vein. Scintigraphy will be performed 24 hours after infusion. Patients will be submitted to frequent clinical, laboratorial and image evaluation during a one-year follow-up. A second liver biopsy will be done in the 3rd month after infusion to check histological, cellular and molecular evolutive changes.

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 prospective open label study is designed to screen all available Gaucher disease patients [either on enzyme replacement therapy (ERT) or not] for hepatitis C virus (HCV) infection. Furthermore to evaluate the safety and effectiveness of combined Sofosbuvir/Ledipasvir regimen given for 12 weeks in chronically infected patients aged 6-18 years.

Randomized, open-label study in treatment naïve and treatment experienced, adolescence to determine the efficacy of Sofosbuvir 400mg/ledipasvir 90mg in treatment naïve and treatment-experienced adolescence. Hepatitis C virus (HCV) infection as measured by the proportion of subjects with sustained viral response 12 weeks after discontinuation of therapy (SVR12)