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Hepatitis C, Chronic clinical trials

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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: 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: NCT02969668 Completed - Clinical trials for Hepatitis C, Chronic

Interferon-free Antiviral Treatment of Chronic Hepatitis C Virus Infection Among Opioid-substituted Patients

INFO
Start date: March 2016
Phase:
Study type: Observational [Patient Registry]

The primary objective of study will be to evaluate the effectiveness of interferon-free direct acting antivirals (IFN-free DAAs) in the treatment of chronic hepatitis C virus (HCV) among patients in opioid-substitution treatment (OST). We hypothesize that rates of sustained virological response will be comparable to non-OST populations. Secondary objectives include the evaluation of safety data, patients' adherence and patient reported outcome measures like functioning (disability), satisfaction with the treatment, health status, general health perceptions and health-related quality of life.

NCT ID: NCT02966795 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study of of Glecaprevir/Pibrentasvir in Adults With Chronic Hepatitis C Virus (HCV) Genotype 5 or 6 Infection

ENDURANCE-5 6
Start date: January 25, 2017
Phase: Phase 3
Study type: Interventional

A Phase 3b, open-label, multicenter study to evaluate the efficacy and safety of glecaprevir/pibrentasvir for an 8- or 12-week treatment duration in participants with chronic hepatitis C virus (HCV) genotype (GT) 5 or 6 infection, with or without compensated cirrhosis respectively.

NCT ID: NCT02964091 Completed - Chronic Hepatitis C Clinical Trials

Simplifying Hepatitis C Antiviral Therapy in Rwanda for Elsewhere in the Developing World

SHARED
Start date: October 2016
Phase: Phase 4
Study type: Interventional

The main purpose of the study is to evaluate the efficacy, safety and tolerability of a medication, ledipasvir/sofosbuvir (LDV/SOF), used to treat individuals with chronic hepatitis C virus (HCV) in Rwandan adults. A sub-cohort of participants will have limited laboratory monitoring to determine the minimum laboratory tests necessary.

NCT ID: NCT02951364 Completed - Hepatitis C Virus Clinical Trials

Harvoni in Patients With Chronic Hepatitis C Virus (HCV) Infection in Korea

Start date: December 5, 2016
Phase:
Study type: Observational

The primary objective of this post-marketing surveillance study is to collect and assess data related to the safety and effectiveness of Harvoni® (ledipasvir/sofosbuvir (LDV/SOF)) treatment regimen, per the approved Korea prescribing information for Harvoni, in routine clinical practice in Korea and to report the results to the Ministry of Food and Drug Safety (MFDS). Participants will be treated as part of routine practice at Korean healthcare centers by accredited physicians.