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Hepatitis clinical trials

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NCT ID: NCT02878863 Withdrawn - Clinical trials for Hepatitis, Autoimmune

Paeoniflorin Combination of Hepatoprotective Drugs Versus Hepatoprotective Drugs Only for Auto-immune Hepatitis

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

An open-label,prospective, randomized pilot study to evaluate the efficacy, safety and tolerability of paeoniflorin, for the treatment of autoimmune hepatitis (AIH) with mild necroinflammatory activity on liver biopsy.

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: NCT02874586 Recruiting - Clinical trials for Hepatitis, Autoimmune

Plasma Exchange Combination of Immunosuppressive Regimens for Auto-immune Hepatitis

Start date: December 2016
Phase: N/A
Study type: Interventional

An open-label,pilot study to evaluate the efficacy and safety of plasma exchange combination of immunosuppressive regimens, for the remission of autoimmune hepatitis (AIH).

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: NCT02865369 Not yet recruiting - Chronic Hepatitis C Clinical Trials

Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment

RELIF-C
Start date: September 2016
Phase: N/A
Study type: Observational [Patient Registry]

A study on regression of liver fibrosis assessed by transient elastography after Daclatasvir and Asunaprevir combined treatment in advanced fibrotic/cirrhotic patients with chronic hepatitis C genotype 1b Infection

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: NCT02863757 Recruiting - Chronic Hepatitis B Clinical Trials

Follow-up of Chronic Hepatitis B Patients With Comorbid Nonalcoholic Fatty Liver Disease

Start date: August 2016
Phase:
Study type: Observational

The purpose of this study is to determine the disease progression in CHB/NAFLD compared with CHB and NAFLD including liver cirrhosis, cirrhotic complications and hepatocellular carcinoma (HCC).

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.