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Hepatitis C clinical trials

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NCT ID: NCT02639338 Completed - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy of SOF/VEL/VOX FDC for 8 Weeks and SOF/VEL for 12 Weeks in Adults Chronic Genotype 3 HCV Infection and Cirrhosis

POLARIS-3
Start date: December 23, 2015
Phase: Phase 3
Study type: Interventional

The primary objective of this study is to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (SOF/VEL/VOX) fixed-dose combination (FDC) for 8 weeks and of treatment with sofosbuvir/velpatasvir (SOF/VEL) FDC for 12 weeks in participants naive to direct-acting antivirals (DAA) with chronic genotype 3 hepatitis C virus (HCV) infection and cirrhosis.

NCT ID: NCT02639247 Completed - Clinical trials for Hepatitis C Virus Infection

Safety and Efficacy of SOF/VEL/VOX FDC for 12 Weeks and SOF/VEL for 12 Weeks in DAA-Experienced Adults With Chronic HCV Infection Who Have Not Received an NS5A Inhibitor

POLARIS-4
Start date: December 23, 2015
Phase: Phase 3
Study type: Interventional

The primary objectives of the study are to evaluate the efficacy, safety, and tolerability of treatment with sofosbuvir/velpatasvir/voxilaprevir (Vosevi®; SOF/VEL/VOX) fixed-dose combination (FDC) for 12 weeks and of sofosbuvir/velpatasvir (Epclusa®; SOF/VEL) FDC for 12 weeks in direct-acting antiviral (DAA)-experienced adults with chronic hepatitis C virus (HCV) infection with or without cirrhosis who have not received prior treatment with a regimen containing an inhibitor of the HCV NS5A protein.

NCT ID: NCT02638233 Recruiting - Chronic Hepatitis C Clinical Trials

Therapy With Ledipasvir/Sofosbuvir in Patients With Genotype 1 HCV Infection Receiving Opiate Substitution Therapy

Start date: September 2015
Phase: Phase 4
Study type: Interventional

Patients with chronic hepatitis C that are under opiate substitution therapy are likely to have psychiatric comorbidities such as depression; hence an Interferon based therapy is contraindicated. Additionally many of these patients have a borderline compliance, which makes it impossible to treat them at specialized hepatological centers. An ideal opportunity to treat this patients is treatment with DAAs (Direct Acting Antiviral) which can be administered daily together with the opiate substitution therapy at a low threshold facility.

NCT ID: NCT02636608 Completed - Chronic Hepatitis C Clinical Trials

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Patients With Chronic Hepatitis C - An Observational Study in Hungary

VERITAS
Start date: November 27, 2015
Phase:
Study type: Observational

The study seeks to provide evidence of the effectiveness and obtain patient reported outcome (PRO), work productivity and safety data of the interferon-free regimen of paritaprevir (PTV)/ritonavir (r) + ombitasvir (OBV), ± dasabuvir (DSV), ± ribavirin in chronic hepatitis C virus infected participants.

NCT ID: NCT02636595 Completed - Hepatitis C Virus Clinical Trials

The Efficacy and Safety of ABT-493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 4, 5, or 6 Infection (ENDURANCE-4)

ENDURANCE-4
Start date: November 2015
Phase: Phase 3
Study type: Interventional

The purpose of this study is to evaluate the effect of response to treatment by evaluating the percentage of subjects achieving a 12-week sustained virologic response (SVR12) after 12 weeks of treatment with ABT-493/ABT-530 and to evaluate the safety of the regimen in participants with chronic hepatitis C virus (HCV) genotype (GT) 4, 5, or 6 infection.

NCT ID: NCT02634008 Completed - Hepatitis C, Acute Clinical Trials

Treatment of Recently Acquired Hepatitis C With the 3D Regimen or G/P

TARGET3D
Start date: June 2016
Phase: Phase 3
Study type: Interventional

An open label, multicentre, international pilot study of paritaprevir/ritonavir, ombitasvir, dasabuvir with or without ribavirin or glecaprevir/pibrentasvir for people with recently acquired hepatitis C virus infection with or without HIV co-infection.

NCT ID: NCT02631772 Completed - Hepatitis C Clinical Trials

LIVE-C-Free: Early and Late Treatment of Hepatitis C With Sofosbuvir/Ledipasvir in Liver Transplant Recipients

Start date: June 1, 2016
Phase: Phase 4
Study type: Interventional

The predominant remaining questions for post-transplant treatment of Hepatitis C virus (HCV) in the DAA (direct acting anti-virals) era are whether a ribavirin-free regimen is possible and whether pre-emptive treatment is now a potential option to prevent long-term damage to the allograft. Our aim is to provide answers to these primary questions with our multicenter, prospective, randomized, open-label intent-to-treat phase IV study

NCT ID: NCT02629172 Completed - Clinical trials for Chronic Hepatitis C Virus

Drug Use-results Survey in Patients Infected With Hepatitis C Virus Genotype 1

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

The main objective of this study is to evaluate the safety and effectiveness of paritaprevir/ritonavir/ombitasvir used for patients infected with HCV genotype 1 in daily practice in Japan.

NCT ID: NCT02628717 Completed - Cirrhosis Clinical Trials

Interferon/Ribavirin-Free Sofosbuvir Based Treatment (AURIC)

AURIC
Start date: July 2013
Phase: N/A
Study type: Observational [Patient Registry]

Since the availability of interferon free direct acting antivirals (DAA) the centers authorized to prescribed these drugs in Austria submitted their data to a central data base (AURIC) using treatment regimes without interferon and ribavirin in patients with advanced liver disease (F3/4)

NCT ID: NCT02628691 Terminated - HIV Clinical Trials

Monitoring Liver Disease Progression in Hepatitis C/HIV Co-infected Patients With No-to-moderate Fibrosis, in Phnom Penh, Cambodia

HCV-Monitoring
Start date: December 17, 2015
Phase: N/A
Study type: Observational

Data on the progression of liver fibrosis in patients co-infected with HIV taking effective suppressive antiretroviral therapy with no fibrosis or mild-to-moderate fibrosis at baseline are scarce. This uncertainty is reflected in lack of clear guidance on the need for earlier (than F3-F4) treatment in co-infected patients. Within our hepatitis C/HIV co-infection project in Cambodia, the investigators have the opportunity to monitor for short-term fibrosis progression in a cohort of co-infected patients with initial no-to-moderate fibrosis being identified during another ongoing study (HCV-Epi) and contribute relevant data to aid the risk/benefit analysis of postponing HCV treatment in HIV/HCV co-infected patients with initial fibrosis stage F0-F2. The HCV-Monitoring study is a mono-centric prospective cohort study proposing a standardized follow-up (clinical, biological and imaging) to monitor for progression of hepatitis C disease in all patients with HIV infection (on anti-retroviral treatment or not) of Sihanouk Hospital Center of Hope (Phnom Penh, Cambodia) who have chronic HCV infection with GT-1, -2, -3 or -6 but are not considered in immediate need of HCV treatment. All adult HIV-infected patients of the cohort (on ART or not yet on ART) of Sihanouk hospital Center of Hope who are identified during the HCV-Epi study having chronic HCV infection (all genotypes) and considered not in immediate need of HCV treatment (= Fibrosis stages F0-F2 and no clinical signs of extra-hepatic disease) will be considered for inclusion and invited to participate. Approximately 70 HCV/HIV co-infected patients with no-to-moderate hepatic fibrosis will be enrolled in this study. Beyond the baseline visit (HCV-Epi), follow-up visits are planned at 6, 12, 18 and 24 months. These patient visits will comprise of a history taking and physical examination focused on hepatic disease and blood sampling for basic hematologic and hepatic function parameters. Additionally, patients will be referred every year for ultrasound and transient elastography measurements and sampling for some additional liver function tests and measurement of HCV-RNA viral load.