Active clinical trials for "Hepatitis C, Chronic"

This study is designed to assess the safety and tolerability of boceprevir dosed 800 mg three times daily (TID) orally (PO) in combination with Peginterferon alfa-2b (PEG2b) 1.5 mcg/kg once a week (QW) administered subcutaneously (SC) plus ribavirin (RBV) (800 to 1400 mg/day) PO in Response Guided Therapy (RGT) in adult Vietnamese subjects with Chronic Hepatitis C, Genotype 1 (CHC GT1) who failed prior treatment with any interferon and ribavirin in Vietnam.

This randomized, double blind, phase II study will evaluate the efficacy and safety of two doses of RO5024048 in combination with ritonavir-boosted danoprevir and Pegasys (peginterferon alpha-2a) and Copegus (ribavirin) in patients who failed a prior protease inhibitor containing regimen with or without pegylated interferon. Patients will be randomized to receive either a 2-week lead-in of RO5024048 (1500 mg or 1000 mg orally twice daily) in combination with Pegasys (180 mcg subcutaneously weekly) and Copegus (1000 mg or 1200 mg orally daily) followed by 24 weeks of therapy with RO5024048 in combination with danoprevir (100 mg orally twice daily) plus ritonavir (100 mg orally twice daily) and Pegasys and Copegus (QUAD therapy), or 24 weeks of therapy with RO5024048 in combination with danoprevir plus ritonavir and Pegasys and Copegus (QUAD therapy). Anticipated time on study treatment is 24 or 26 weeks, with a treatment-free follow-up of 24 weeks.

This is a phase 4 clinical trial to treat patients who have failed to treat with regimen based on an inhibitor of the NS5A

The purpose of this multicenter, single-arm, combination-drug study, which includes 12 weeks of treatment and 24 weeks of follow-up, is to evaluate the safety, efficacy and pharmacokinetics of ombitasvir/paritaprevir/ritonavir in Japanese adults infected with HCV GT1b, who are treatment-naïve or treatment-experienced to an IFN-based regimen and who have ESRD on HD.

Hepatitis C virus infection is the most common blood-borne infection in the United States and is a leading cause of chronic liver disease affecting 130 million people around the world. It is estimated that 1.6% of the US population may be affected by Hepatitis C infection. The only recommended treatment that has been approved for your condition is the use of interferon and ribavirin. In patients with chronic Hepatitis C, there tends to be an accumulation of fat in the liver. Fatty liver has been associated with failure of treatment. The accumulation of fat in the liver has been blamed on a particular type of fat called triglycerides. Fish oil, by reducing a type of fat called VLDL, can lower the triglyceride concentration by as much as 50 percent or more. This study seeks to determine if the administration of fish oil along with standard treatment to patients with Hepatitis C will increase the treatment response rates.

The goal of this pilot study is to examine both efficacy and tolerability in patients with HCV genotype 1 and mild decompensation with Child-Pugh-Turcott score of 6 or lower. The CPT score is used to assess the prognosis of chronic liver diseases, as well as the required strength and treatment and necessity of liver transplantation. A higher CPT score denotes higher necessity of liver transplantation.

Primary Efficacy Objective -To assess whether a 12-week treatment course with oral 50 mg elbasvir plus 100 mg grazoprevir given in a single daily dose to treatment-naïve patients with end-stage renal disease (ESRD) and infected with genotype 4 (GT4) chronic HCV (CHC) infection can produce a sustained viral response (SVR), i.e. HCV RNA below the lower limit of quantification [LLOQ] for 12 weeks (SVR12) after completion of the study treatment course Secondary Objectives To assess the efficacy of elbasvir/grazoprevir in suppressing HCV viremia in treatment-naïve GT4 CHC patients at each scheduled visit and clinically meaningful endpoints (Week 2, 8 and 12 [End of Treatment - EOT]) and 24 (SVR12) To assess the safety and tolerability of a 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC. To assess liver fibrosis by non-invasive evaluation of liver stiffness (Fibroscan®) in the same patients before treatment and EOT and SVR12 Clinical hypotheses. Primary Efficacy Hypothesis - A 12-week treatment course with elbasvir/grazoprevir in treatment-naïve patients with ESRD and infected with GT4 CHC infection will result in an HCV RNA below the LLOQ in 95% of patients within 2 weeks of treatment, and at least 95% will have an SVR12. Secondary hypotheses A 12-week treatment course with elbasvir/grazoprevir in ESRD GT4 treatment-naïve patients will result in undetectable viremia in 95% patients at Week 2, 4, 8 and 12 (EOT) and 24 (SVR12) Treatment will be safe and well-tolerated in these patients, as determined by the type and number of adverse events identified through laboratory testing, vital signs and physical examinations. In these patients with liver fibrosis before treatment, the liver fibrosis as assessed by non-invasive evaluation of liver stiffness (Fibroscan®) will improve by EOT and SVR12

There is only one kind of treatment (simeprevir 150 mg + sofosbuvir 400 mg+daclatasvir 60 mg) in this study but the treatment duration may be different depending on patients' response to the antiviral therapy and whether patients have liver cirrhosis. If patients have no cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 3 weeks, otherwise the treatment duration is 4 weeks. If patients have cirrhosis and the HCV viral load on day 2 is <500 IU/ml, patients will receive sofosbuvir, daclatasvir and simeprevir for 6 weeks, otherwise the treatment duration will be 8 weeks.

Hepatitis C virus (HCV) infection is easy to chronic and can progress to cirrhosis and liver cancer. Direct-acting antiviral treatment can significantly improve the prognosis of the disease and the efficacy is seemingly not affected by a variety of viral factors. In addition, direct-acting antiviral agents therapy may affect the transformation of the immune cells and ameliorate the host immune status consequently. This study mainly investigated the relationship between Direct Acting Antiviral Treatment effect and the functional activity of myeloid-derived suppressor cells (MDSCs) and natural killer cells (NK cells) in Chronic Hepatitis C.

This is a randomized, double blind, multi-center, placebo controlled, three parallel arms, Phase IIb/III clinical study to evaluate the effects of adding a TCM-700C with a low or high dose onto the combination treatment (PegIFN plus RBV) for subjects with naive genotype 1 HCV infection. This will be demonstrated by a higher sustained virologic response rate, defined as the absence of detectable HCV RNA 24 weeks after the termination of combination treatment, compared with the placebo add-on.