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Hepatitis C, Chronic clinical trials

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NCT ID: NCT03020095 Completed - Chronic Hepatitis C Clinical Trials

Efficacy and Safety of Ravidasvir + Danoprevir/r 12-week Oral Therapy in Treatment-Naive Non Cirrhotic G1 CHC Taiwan

Start date: August 2015
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy, safety and tolerability of Ravidasvir (ASC16) in combination with Ritonavir-boosted Danoprevir(ASC08) and Ribavirin in treatment-naive no-cirrhotic Taiwanese patients who have chronic hepatitis C genotype1.

NCT ID: NCT03020082 Completed - Chronic Hepatitis C Clinical Trials

Efficacy and Safety of Danoprevir/r + PR 12week Triple Therapy in Treatment Naive Non-Cirrhotic G1 CHC China III

Start date: June 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the efficacy and safety of Ritonavir-boosted ASC08 (Danoprevir) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.

NCT ID: NCT03020004 Completed - Chronic Hepatitis C Clinical Trials

Efficacy and Safety of Danoprevir/r + PR 12-week Triple Therapy in Treatment-Naive, Non-Cirrhotic, G1 CHC China II

Start date: January 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the Efficacy, Safety and Pharmacokinetics of Ritonavir-boosted Danoprevir (ASC08) in Combination with Peg-IFN and RBV in Treatment-Naive Non-Cirrhotic Patients Who Have Chronic Hepatitis Genotype 1.

NCT ID: NCT03018353 Enrolling by invitation - Clinical trials for Hepatitis C, Chronic

Curing HCV in Incarcerated Patients

CHIP
Start date: March 5, 2017
Phase: Phase 4
Study type: Interventional

Curing HCV in Incarcerated Patients (CHIP) is a 1-year demonstration project that will assess the feasibility of a HCV treatment program in the San Francisco City & County Jail. The Jail Health Services will treat 100 patients using the FDA approved combination treatment, sofosbuvir/velpatasvir, Epclusa® and will continue their treatment during incarceration and after their release (if applicable).

NCT ID: NCT03003338 Terminated - Clinical trials for Hepatitis C, Chronic

MHH-HCV-NPM-Neuropsychiatric Manifestations of HCV-infection During and After Treatment With OBV/PTV/r and DSV

Start date: October 24, 2017
Phase: Phase 4
Study type: Interventional

This is a 1:1 randomized double-blind Placebo-controlled moncenter Phase IV study to investigate whether a successful interferon-free treatment of HCV-infection with ombitasvir/paritaprevir/ritonavir (OBV/PTV/r) in combination with dasabuvir (DSV) improves the patients' attention ability as compared to placebo as measured with the Att Test Sum Score change from baseline to week 12. A total of 30 patients with non-cirrhotic genotype 1b HCV infection will be randomly assigned to receive 12 weeks verum followed by 12 weeks Placebo (arm A) versus 12 weeks Placebo followed by 12 weeks verum (arm B). Patients will be followed up for 48 weeks.

NCT ID: NCT03002818 Completed - Clinical trials for Chronic Hepatitis C Virus (HCV)

Quality of Life Measurement in Treatment Naïve Patients With Hepatitis C Virus (HCV) Genotype 1 (GT1) Suffering From Fatigue and Receiving Ombitasvir, Paritaprevir, and Ritonavir and Dasabuvir (Viekirax®/Exviera®)

HEMATITE
Start date: March 1, 2017
Phase:
Study type: Observational

This is an observational, prospective, open-label, single-arm, multicenter, real-life study designed to observe the impact of paritaprevir/ritonavir/ombitasvir with dasabuvir regimen (Viekirax®/Exviera®, 3D regimen) on total daytime physical activity and fatigue in participants with HCV GT1.

NCT ID: NCT03000023 Completed - Hepatitis C Clinical Trials

Anticipated and Perceived Benefits Following Hepatitis C Treatment

Start date: October 2016
Phase:
Study type: Observational

The study is both qualitative and quantitative, gathering patient's perceptions of HCV treatment benefits before and after HCV treatment by administering surveys and conducting in-depth qualitative patient interviews. The study seeks to understand all anticipated and actual benefits patients perceive before and after viral eradication.

NCT ID: NCT02993250 Completed - Clinical trials for Hepatitis C, Chronic

A Study to Investigate the Safety, Pharmacokinetics, and Efficacy of Combination Treatment of AL-335, Odalasvir, and Simeprevir in Japanese Participants With Chronic Hepatitis C Genotype 1 or 2 Virus Infection, With or Without Compensated Cirrhosis Who Are Direct Acting Antiviral Treatment-naive

Start date: December 21, 2016
Phase: Phase 2
Study type: Interventional

The main purpose of this study is to evaluate the safety and tolerability of a combination treatment of AL-335, odalasvir (ODV), and simeprevir (SMV) for 8 weeks in Japanese participants with genotype 1 or 2 chronic hepatitis C virus (HCV) infection without cirrhosis and for 12 weeks in direct-acting antiviral (DAA)‑naive Japanese participants with genotype 1 or 2 chronic HCV infection with compensated cirrhosis.

NCT ID: NCT02972723 Completed - Clinical trials for Chronic Hepatitis C Infection

Metformin Therapy in HCV Infection

Start date: March 2011
Phase: Phase 4
Study type: Interventional

Hepatitis C virus infection (HCV) is a major cause of cirrhosis and death from liver disease worldwide. Current therapy for HCV with interferon based therapies results in cure rates of around 5055% which leaves a significant number of patients without effective therapy. HCV induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce the response to antiHCV therapy. This finding stimulated initial studies looking at agents that may reduce insulin resistance as additional therapy in HCV infection. A study using metformin in addition to interferon and ribavirin showed a nonsignificant increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection AND demonstrable insulin resistance. The assumption was made that the potential effect of metformin was likely to be on insulin resistance and thus by modulating this enhances response. The investigators (Prof M Harris, University of Leeds) have data (currently unpublished)suggesting that metformin may have an antiviral effect independent of its effect on insulin resistance, thus raising the possibility that metformin may have a direct antiviral effect in vivo. Given that the development of specific antiHCV agents which target viral proteins such as its polymerase and protease are in trial development but have so far proved either highly toxic or are likely to have a huge cost there is considerable rationale for looking at alternative potential antiHCV agents and in this context metformin is cheap, readily available and has an excellent safety profile. This pilot study therefore addresses the question "Does metformin therapy result in a significant drop in HCV viral load in chronically infected patients?"

NCT ID: NCT02971033 Terminated - Chronic Hepatitis C Clinical Trials

Ezetimibe as a Safe and Efficacious Treatment for Chronic Hepatitis C

Start date: April 16, 2018
Phase: Phase 2
Study type: Interventional

To address the need for more affordable hepatitis C virus (HCV) antivirals with high barriers to viral resistance and strategies to shorten the current treatment duration, the goal is to develop affordable therapeutic regimens to prevent HCV entry/spread and test the efficacy of those inhibitors for treating HCV infection. The investigators recently discovered that a major cholesterol uptake receptor is required for HCV entry into hepatocytes and that there is already an FDA-approved drug that inhibits cholesterol uptake by this receptor. Importantly the same drug also potently blocks HCV entry in human liver cells both in cell culture and in a small animal model. Further, looking back at people who were previously treated for HCV infection, the investigators found treatment response to be better (i.e. larger viral log reduction) in patients who happened to be taking ezetimibe (EZE). Hence, the objective of this study is to assess whether the FDA-approved drug (ezetimibe) is useful for the treatment of chronic HCV. The investigators predict that when administered as monotherapy ezetimibe will reduce HCV viremia perhaps allowing for viral clearance and that when included in combination treatment regimens that EZE will increase HCV decline resulting in faster viral clearance (i.e. shorter/cheaper direct-acting antiviral [DAA] therapy). To test these hypotheses, the investigators will execute the following aims: (1) Assess the efficacy of EZE monotherapy in chronically HCV infected and predict time to cure; (2) Assess the efficacy of EZE as an adjunct therapy in chronically HCV infected patients undergoing currently approved HCV DAA treatment.