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Hepatitis C clinical trials

View clinical trials related to Hepatitis C.

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NCT ID: NCT03050905 Completed - HCV Coinfection Clinical Trials

Proof of Concept Study To Evaluate the Efficacy and Justification Of OBV/PTV/r and DSV In Adults With Chronic Hepatitis C Virus Genotype 2K/1B

Start date: June 22, 2017
Phase: Phase 4
Study type: Interventional

HCV infection is one of the most prevalent etiologies for liver cirrhosis and hepatocellular carcinoma. HCV is highly heterogeneous, with seven confirmed major genotypes. Each genotype displays a different geographic distribution. Since different HCV genotypes react differently on available antiviral therapies, the correct identification of HCV genotype serves as a marker of responsiveness and an indicator for duration of treatment. The recombinant HCV genotype 2k/1b was first described in Saint Petersburg in 2002. A sequencing strategy led to the detection of HCV genotype 2k/1b. However, clinical laboratories often use the VERSANT HCV Genotype 2.0 Assay for routine HCV genotyping. This assay may potentially misclassify these HCV strains as genotype 2a/2c. Based on these findings, the number of patients with 2k/1b may be underestimated. AbbVie's IFN-free regimen for the treatment of chronic HCV genotype 1b infection includes 3 DAAs with distinct mechanisms of action and non-overlapping resistance pattern to target HCV proteins essential for viral replication. The high efficacy of the 3D regimen was proven in registration clinical trials and RW for 1b population. 3D regimen has not been evaluated for patients with HCV genotype 2K/1B. Primary Objective • Evaluate the efficacy of ombitasvir/paritaprevir/ritonavir and dasabuvir (3D) in an interferon-free treatment regimen as assessed by SVR in adult patients with HCV 2k/1b. Study Design: .The study will include 1 group. Patients with HCV GT 2k1b will be treated according to label recommendation as for GT1b (with and without cirrhosis) for 12 weeks. All subjects will receive Ombitasvir/Paritaprevir/Ritonavir and Dasabuvir. Subjects will be assessed for antiviral response, clinical outcomes, patient reported adverse events and presence and emergence of resistance associated variants. Subjects will be followed for up to 12 weeks of treatment and extra 24 weeks of follow up. Scheduled visits will include: physician assessment and blood tests including HCV resistance mutations.

NCT ID: NCT03042520 Recruiting - Diabetes Mellitus Clinical Trials

Long-term Outcomes of Chronic Hepatitis C Patients Post Sofosbuvir-based Treatment

LONGHEAD
Start date: August 2016
Phase:
Study type: Observational

Primary Objective: To evaluate the long-term outcomes including liver related morbidity, mortality and hepatocellular carcinoma (HCC) development as compared to those of historical control with interferon(IFN)-based treatment. Secondary Objective: 1. To access liver fibrosis progression/regression in CHC patients after sofosbuvir-based treatment. 2. To investigate the long-term outcomes of extrahepatic manifestations of the sofosbuvir-based treated cohort as compared to their pretreatment status.

NCT ID: NCT03038763 Completed - Hepatitis C Clinical Trials

Vertical Transmission of Hepatitis C in Adult Children of Female Baby Boomers

Start date: May 11, 2017
Phase:
Study type: Observational

The investigators aim to determine the prevalence of hepatitis C in the adult children of female baby boomers. During the years baby boomers were becoming pregnant, hepatitis C testing was either not available or was not standard of care. Because of this, participants' children may be unaware of participants' risk of hepatitis C.

NCT ID: NCT03036852 Completed - Chronic Hepatitis C Clinical Trials

Sofosbuvir/Velpatasvir in Adults With Chronic Hepatitis C Virus Infection Who Are on Dialysis for End Stage Renal Disease

SOF/VEL ESRD
Start date: March 22, 2017
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate safety, efficacy, and tolerability of treatment with sofosbuvir/velpatasvir (SOF/VEL) for 12 weeks in adults on dialysis for end stage renal disease (ESRD) with chronic hepatitis C virus (HCV) infection of any genotype.

NCT ID: NCT03036839 Completed - Clinical trials for Hepatitis C Virus Infection

Ledipasvir/Sofosbuvir in Adults With Chronic Hepatitis C Virus (HCV) Infection Who Are on Dialysis for End Stage Renal Disease

ESRD
Start date: June 27, 2017
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety, efficacy and tolerability of treatment with ledipasvir/sofosbuvir (LDV/SOF) in adults with chronic HCV infection who are on dialysis for ESRD.

NCT ID: NCT03032666 Completed - Hepatitis C Clinical Trials

Sofosbuvir/Ledipasvir for Hepatitis C Genotype 1-6 in Patients With Transfusion-Dependent Thalassemia: An Open Label Trial

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

Sustained Viral Response following 12-week therapy (SVR 12) with sofosbuvir/ledipasvir in transfusion-dependent patients with HCV genotype 1-6 Secondary Objective(s): Assessment of transfusion requirements Adverse events Efficacy in treatment-naïve vs. relapsers vs. null responders Efficacy in patients with advanced fibrosis/cirrhosis vs. F1, F2 by elastography

NCT ID: NCT03026569 Completed - Chronic Infection Clinical Trials

Orange Juice Consumption in Patients With Hepatitis C

Start date: May 2012
Phase: N/A
Study type: Interventional

This study aimed to verify whether orange juice, source of citrus flavonoids and vitamin C, may contribute to the treatment of patients with chronic hepatitis C.

NCT ID: NCT03026023 Withdrawn - Hepatitis C Clinical Trials

Preemptive Zepatier Treatment in Donor HCV Positive to Recipient HCV Negative Cardiac Transplant

Start date: August 1, 2018
Phase: Phase 4
Study type: Interventional

This is a proof of concept, single center study for the donation of HCV-positive hearts to HCV negative recipient patients, with preemptive, interventional treatment with 12-16 weeks of grazoprevir and elbasvir (with or without ribavirin) to prevent HCV transmission upon transplantation.

NCT ID: NCT03025074 Recruiting - Hepatitis C Clinical Trials

Blood Collection Biorepository for Liver Disease Research

Start date: July 2013
Phase:
Study type: Observational [Patient Registry]

The purpose of establishing a biorepository is to provide high quality specimens (serum, plasma, buffy coat and liver tissue) for future researchers who are studying the effects that fatty liver and viral diseases have on the liver.

NCT ID: NCT03022981 Completed - Clinical trials for Hepatitis C Virus Infection

Study to Investigate the Safety and Efficacy of Sofosbuvir/Velpatasvir in Adolescents and Children With Chronic HCV Infection

Start date: January 26, 2017
Phase: Phase 2
Study type: Interventional

This study will have 2 parts: Pharmacokinetics (PK) Lead-in Phase and the Treatment Phase. The primary objective of the PK Lead-in Phase is to evaluate the steady state PK and confirm the dose of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in pediatric participants with chronic hepatitis C virus (HCV) infection. The primary objective of the Treatment Phase is to evaluate the safety and tolerability of SOF/VEL for 12 weeks in pediatric participants with chronic HCV.