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Hepatitis A clinical trials

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NCT ID: NCT02940691 Terminated - Hepatitis C Clinical Trials

Scale-up of Treatment of Hepatitis C Infection Among People Who Inject Drugs

DARLO-C
Start date: May 1, 2017
Phase: Phase 4
Study type: Interventional

This study is a phase IV, open-label, single arm, multicentre study whose aim is to assess whether interferon-free and ribavirin-free Direct Acting Antiviral (DAA) Hepatitis C Virus (HCV) therapy with grazoprevir/elbasvir, will be feasible for the treatment of People who inject drugs (PWID) with recent injecting drug use or people receiving opioid substitution therapy and chronic HCV genotype 1 or 4 infection.

NCT ID: NCT02826018 Terminated - Hepatitis B Clinical Trials

A Study of ALN-HBV in Healthy Adult Volunteers and Non-cirrhotic Patients With Chronic Hepatitis B Virus (HBV) Infection

Start date: June 24, 2016
Phase: Phase 1
Study type: Interventional

The purpose of this study is to determine the safety, tolerability and pharmacokinetics of ALN-HBV in healthy adult volunteers and patients with chronic hepatitis B virus (HBV) infection. In addition, the study will assess antiviral efficacy of ALN-HBV in patients with HBV.

NCT ID: NCT02797522 Terminated - Hepatitis B Clinical Trials

A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)

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

Normal healthy volunteer (NHV) participants will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 Injection or placebo. The maximum study duration for NHVs is approximately 21 weeks. Hepatitis B e Antigen (HBeAg)-negative participants with (CHB) will enroll sequentially into 3 dose levels (8 patients per dose level) to receive multiple doses of open label ARC-521 Injection. For each CHB participant the maximum study duration is approximately 37 weeks.

NCT ID: NCT02791256 Terminated - Clinical trials for Hepatitis C, Chronic

A Study of Peginterferon Alfa-2a Plus Ribavirin in Early Non-Responder Participants With Chronic Hepatitis C (CHC) Genotype 1, 4, 5, and 6

Start date: June 2005
Phase: Phase 3
Study type: Interventional

This multicenter, open-label, uncontrolled study will evaluate the efficacy and safety of increasing the dose of peginterferon alfa-2a (Pegasys) in participants with Genotype 1/4/5/6 CHC and an early non-response to a standard course of peginterferon alfa-2a plus ribavirin. The study will consist of screening (4 weeks), treatment (32 weeks), and follow-up (24 weeks).

NCT ID: NCT02759315 Terminated - Clinical trials for Hepatitis C, Chronic

Efficacy and Safety of Uprifosbuvir (MK-3682) With Ruzasvir (MK-8408) in Adults With Chronic Hepatitis C Genotype 1, 2, 3, 4, 5 or 6 Infection (MK-3682-035)

Start date: May 3, 2016
Phase: Phase 2
Study type: Interventional

This study is an open-label, multi-center trial to evaluate the novel 2-drug regimen of uprifosbuvir (MK-3682) 450 mg and ruzasvir (MK-8408) 60 mg in participants with chronic hepatitis C virus (HCV) genotype (GT)1, GT2, GT3, GT4, GT5, or GT6 infection. The impact of the study treatment regimen on the percentage of participants with undetectable HCV ribonucleic acid [RNA] 12 weeks after completing study treatment (SVR12) will be evaluated.

NCT ID: NCT02738008 Terminated - Hepatitis B Clinical Trials

Extension Study of the Safety and Efficacy of Multi-dose Intravenous ARC-520 in Patients With Chronic Hepatitis B (HBV) Infection

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

Chronic HBV patients will receive 9 doses of open-label ARC-520 once every 4 weeks and be evaluated for safety and efficacy.

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.

NCT ID: NCT02613403 Terminated - Hepatitis C Clinical Trials

Efficacy and Safety of Grazoprevir (+) Uprifosbuvir (+) Ruzasvir (MK-3682B) (MK-5172 + MK-3682 + MK-8408) Fixed Dose Combination in Chronic HCV Participants Failing Prior Antiviral Treatment (MK-3682-021)

Start date: December 10, 2015
Phase: Phase 2
Study type: Interventional

This is a randomized, multicenter, 2-part, open-label trial of the combination regimen of grazoprevir (GZR [MK-5172]; 100mg), uprifosbuvir (UPR [MK-3682]; 450 mg) and ruzasvir (RZR [MK-8408]; 60 mg) with and without Ribavirin (RBV) in cirrhotic (C) or non-cirrhotic (NC) participants infected with hepatitis C virus (HCV) previously failing a direct-acting antiviral regimen (DAA). The combination regimen, referred to as MK-3682B, will be administered as two fixed-dose combination (FDC) tablets, given once-daily. The study will evaluate the efficacy of MK-3682B with or without RBV as assessed by the proportion of participants achieving Sustained Virologic Response 12 weeks (SVR12) after the end of all study therapy.

NCT ID: NCT02604355 Terminated - Clinical trials for Hepatitis B, Chronic

A Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of RO7020322 Following Oral Administration in Healthy Participants and Chronic Hepatitis B Patients

Start date: November 28, 2015
Phase: Phase 1
Study type: Interventional

This is a multiple-center, randomized, double-blind, placebo-controlled, single-ascending dose and multiple-ascending dose, adaptive parallel study to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of RO7020322 following oral administration in healthy participants and chronic hepatitis B patients.

NCT ID: NCT02604212 Terminated - Hepatitis B Clinical Trials

A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection

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

Patients with HBeAG positive, chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.