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Hepatitis clinical trials

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NCT ID: NCT02881008 Completed - Chronic Hepatitis B Clinical Trials

Myrcludex B vs Entecavir in Patients With HBeAg Negative Chronic Hepatitis B

Start date: November 14, 2012
Phase: Phase 1/Phase 2
Study type: Interventional

A randomized, open-label multicentre clinical trial of daily Myrcludex B versus entecavir in patients with HBeAg negative chronic hepatitis B.

NCT ID: NCT02877199 Completed - Hepatitis C Clinical Trials

Anti-E1E2 Antibodies (D32.10 Epitope-binding Antibodies) and HCV Triple Therapy

Start date: June 2014
Phase: N/A
Study type: Observational

The hypothesis was to check whether baseline anti-E1E2 antibodies were correlated with the on-treatment viral kinetics and could predict virological outcome in treatment-experienced HCV-infected cirrhotic patients receiving protease inhibitor-based triple therapy.

NCT ID: NCT02876419 Completed - Clinical trials for Hepatitis B, Chronic

A Long Term Follow-up Study of Patients From the REP 301 Protocol

Start date: August 2016
Phase:
Study type: Observational

The REP 301 treatment protocol involved the treatment of patients with chronic hepatitis B / hepatitis D co-infection with two agents: REP 2139-Ca and pegylated interferon (peg-IFN). In this protocol, similar reduction/clearance of serum HBsAg and improved response to immunotherapy were observed in addition to clearance of serum HDV RNA. The REP 301 protocol was designed to include a 24 week follow-up period after treatment, however given the strong antiviral response against HBV and HDV infection in these patients, it is now important to extend the follow-up period in these patients to monitor over a longer period after treatment the safety and efficacy combined REP 2139-Ca / peg-IFN treatment in patients in the REP 301 protocol.

NCT ID: NCT02874066 Completed - Hepatitis Viruses Clinical Trials

PrOD for Non-Cirrhotic Patients With HCV-1b Receiving Hemodialysis

PIVOTAL
Start date: March 13, 2017
Phase: Phase 4
Study type: Interventional

Hepatitis C virus (HCV) infection is common in patients receiving hemodialysis. The uptake of antiviral therapy for these patients is limited in the era of interferon (IFN) plus ribavirin (RBV), probably because the sustained virologic response (SVR) rates are low and the risk of treatment-related adverse events (AEs) are high. In the era of IFN-free direct acting antiviral agents (DAAs), several studies have indicated high rates of SVR and excellent safety profiles to treat patients with severe renal impairment. With regard to ombitasvir/paritaprevir/ritonavir plus dasabuvir (PrOD) treatment, a phase 2 study (RUBY-1) study has shown 90% of SVR in treatment-naive HCV-1 patients with chronic kidney disease (CKD) stage 4 or 5. Among the HCV-1b patients, who received PrOD for 12 weeks, all 7 patients achieved SVR. Although the data confirmed the excellent safety and efficacy in HCV-1b patients with severe renal impairment, the patient number was small and the data with regard to treatment-experienced patients was lacking. Therefore, we aimed to evaluated the safety and efficacy of ProD for 12 weeks in treatment-naive and treatment-experienced HCV-1b patients receiving hemodialysis.

NCT ID: NCT02868242 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed Dose Combination in the Treatment of Hepatitis C Virus (HCV) Infection in Pediatric Participants Undergoing Cancer Chemotherapy

Start date: August 28, 2016
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of ledipasvir/sofosbuvir (LDV/SOF) in treating hepatitis C virus (HCV) infection in pediatric participants who are undergoing cancer chemotherapy.

NCT ID: NCT02864199 Completed - Clinical trials for Hepatitis C, Chronic

A Study of Peginterferon Alfa-2a (Pegasys) and Ribavirin (Copegus) Combination Therapy in Participants With Chronic Hepatitis C (CHC) and Various Degrees of Renal Impairment

Start date: February 2004
Phase: Phase 4
Study type: Interventional

This study will evaluate the pharmacokinetics (area under the curve [AUC], maximum concentration [Cmax], and other parameters) and tolerability of peginterferon alfa-2a and ribavirin combination therapy following single and multiple doses in participants with CHC infection and moderate to severe renal impairment or end-stage renal disease (ESRD) receiving hemodialysis. The anticipated time on study treatment is up to 48 weeks, and the target sample size is 48 individuals.

NCT ID: NCT02862548 Completed - Chronic Hepatitis B Clinical Trials

Efficacy and Safety of Tenofovir Alafenamide (TAF) Versus Tenofovir Disoproxil Fumarate (TDF)-Containing Regimens in Participants With Chronic Hepatitis B Virus (HBV) Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant

Start date: September 16, 2016
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety, tolerability, and efficacy of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF)-containing regimens at Week 24 in participants with chronic hepatitis B virus (HBV) infection and Stage 2 or greater chronic kidney disease who have received a liver transplant.

NCT ID: NCT02862106 Completed - Chronic Hepatitis B Clinical Trials

Second Stage:Open-label Study of Therapeutic Hepatitis B Vaccine (Mimogen-based) for Chronic Hepatitis B

Start date: September 2010
Phase: Phase 2
Study type: Interventional

The purpose is to evaluate efficacy and safety of therapeutic HBV vaccine (mimogen-based) treatment in chronic hepatitis B patients and to explore the most effective dosage and provide the rational for optimal dosing schedule.

NCT ID: NCT02859584 Completed - Acute Hepatitis Clinical Trials

ADRENAL FUNCTION IN PATIENTS WITH ACUTE HEPATITIS

CORT-HEPAT
Start date: August 2011
Phase: N/A
Study type: Interventional

A high frequency of adrenal dysfunction (AD) has been reported in severe acute hepatitis (SAH) using the dosage of serum total cortisol (STC). Because 90% of circulating serum cortisol is bound to proteins that are altered in SAH, we aimed to investigate the effect of decreased cortisol-binding proteins on STC, serum free cortisol (SFC) and salivary cortisol (SalivCort) in SAH. Baseline (T0) and cosyntropin-stimulated (T60) STC, SFC and SalivCort concentrations were measured

NCT ID: NCT02858180 Completed - Heart Failure Clinical Trials

Hepatitis C Virus(HCV) Heart and Lung Study

Start date: December 2016
Phase: Phase 4
Study type: Interventional

This is a multicenter study in Hepatitis C Virus (HCV) infected adult patients who also have advanced cardiac disease or advanced lung disease.