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Hepatitis C clinical trials

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NCT ID: NCT04385407 Completed - Clinical trials for Chronic Hepatitis C Virus Infection

Sofosbuvir With Ribavirin or Simeprevir With HCV GT4 Egyptian Patients

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

A total of 201 participants with chronic HCV GT4 infection were allocated into two groups. One group participants were treated with SOF plus RBV (24 weeks). The second group was treated with SOF plus SMV (12 weeks).

NCT ID: NCT04382937 Completed - Clinical trials for Chronic Hepatitis C Virus Infection

Ropeginterferon Alfa-2b (P1101) Phase 3 Study in Interferon Treatment-Naive Subjects With HCV Genotype 2 Infection

Start date: January 12, 2016
Phase: Phase 3
Study type: Interventional

Primary objective: To demonstrate non-inferiority in sustained virologic response (SVR, undetectable HCV RNA at Follow up week 12) between PEG-Intron 1.5 µg per kg SC Q1W + Ribavirin 800-1400 mg PO daily and P1101 400 µg SC Q2W + Ribavirin 800-1400 mg PO daily for the treatment of chronic HCV genotype 2 infection

NCT ID: NCT04382404 Completed - Clinical trials for Hepatitis C, Chronic

Treatment of Chronic Hepatitis C During Pregnancy With Sofosbuvir/Velpatasvir

Start date: October 22, 2020
Phase: Phase 1
Study type: Interventional

A single-arm, single-center, open label Phase 1 study of a 12-week course of Sofosbuvir (SOF)/Velpatasvir (VEL) in 10 HCV-infected pregnant women 1 that will evaluate the plasma pharmacokinetic parameters of SOF/VEL administered during pregnancy and compare them to those of a historical cohort of nonpregnant women.

NCT ID: NCT04382339 Completed - Clinical trials for Hepatitis C Virus Infection

Sofosbuvir/Pegylated-interferon Plus Ribavirin With HCV Genotype 4

HCV
Start date: March 2015
Phase: Phase 1/Phase 2
Study type: Interventional

This study aims to assess the efficacy and safety of sofosbuvir (SOF) with pegylated interferon (PegINF)/ribavirin (RBV) for chronic HCV GT4 participants

NCT ID: NCT04378608 Completed - Clinical trials for Hepatitis C Virus Infection

Ombitasvir /Paritaprevir/Ritonavir Plus Ribavirin on HCV GT4

Start date: January 5, 2017
Phase: Phase 1/Phase 2
Study type: Interventional

The objective of the investigators was to delineate the efficacy and safety of Ombitasvir, paritaprevir with ritonavir (OBV/PTV/r) plus ribavirin (RBV) on chronic HCV GT4 Egyptian naïve patients

NCT ID: NCT04366973 Completed - Clinical trials for Hepatitis C Virus (HCV)

A Study Describing the Care Cascade and Effectiveness and Safety of Glecaprevir/Pibrentasvir in Adult Participants With Hepatitis C Virus in French Addiction Centers

NeoVie
Start date: May 26, 2020
Phase:
Study type: Observational

Hepatitis C Virus is liver disease and is a leading cause of death and morbidity with around 71 million people affected worldwide. Widespread availability of highly effective direct-acting antivirals (DAAs) have dramatically changed the treatment landscape of HCV with a cure rate of over 95%. In May 2019, French Health Authorities expanded prescription abilities to all physicians treating adult treatment-naive patients with HCV without cirrhosis of the liver. This study will assess the treatment uptake and barriers to treatment by non-HCV specialist in France in community-based addiction centers. Beyond these evaluations, data on health resource utilization in addiction centers, level of knowledge of both patients and providers on HCV infection and treatment, care cascade, effectiveness and safety of Glecaprevir/Pibrentasvir among patients treated in addiction centers and evolution of addiction behavior after treatment are of specific interest. Glecaprevir/Pibrentasvir is a drug approved to treat HCV. About 400 Adult participants with a confirmed positive HCV ribonucleic acid (RNA) test will be enrolled in the study at approximately 30 addiction centers in France. All participants will attend an inclusion visit. Participants who are not prescribed Glecaprevir/Pibrentasvir at the inclusion visit will have no further follow-up in the study. Participants who are prescribed Glecaprevir/Pibrentasvir will take three tablets once daily. The duration of the study is approximately 12 months. All study visits will occur during routine clinical practice but there may be a higher burden for participants prescribed Glecaprevir/Pibrentasvir. These participants will be asked to complete questionnaires after each visit.

NCT ID: NCT04366492 Completed - HIV Infections Clinical Trials

HBV/HCV/HIV in Belgian Prisons

Start date: April 1, 2019
Phase: N/A
Study type: Interventional

To assess the prevalence of blood-borne viral infections in prisons in Belgium, screening will be executed in several prisons in Flanders, Brussels and Wallonia to obtain a geographical representative distribution. Upon informed consent screening will be performed using whole capillary blood (finger prick testing) with three different tests for HCV Ab, HBsAg and HIV. Screening will be performed first. While awaiting the test result (15-20min), the participant can fill out a questionnaire (together with the study nurse), concerning risk factors for HCV, HBV and HIV infection. This questionnaire is filled out directly online, and will be immediately implemented in the encoded database. The database is set-up according to the rules of good clinical practice. (Castor EDC software). The results will be filled out immediately by the prison staff in this database after it is filled out by the participant, minimizing the risk of displacement of test results.

NCT ID: NCT04363411 Completed - Hepatitis c Clinical Trials

Reaching Out to the UNdiagnosed People Infected With Blood Borne Viral Infections

RUNtoBBV
Start date: October 25, 2018
Phase: N/A
Study type: Interventional

Title Reaching out to the UNdiagnosed people infected with blood-borne viral infections (RUNtoBBV) Objectives 1. To study the efficacy of an outreach methodology to increase the uptake for screening, linkage to care and treatment in (active or former) people who use drugs (PWUD) Trial design Prospective multicenter interventional cohort design Number of subjects 336 inclusions (with prevalence of HCV Ab: 30%) - 168 Antwerp - 168 Limburg Selection criteria Inclusion criteria: - 18 years of age - History of/ or active drug use - Written informed consent obtained Exclusion criteria - Currently enrolled in centralized OST program of Free Clinic or CAD Limburg Endpoints The following endpoints will be compared between the centers in Limburg and Antwerp: (Main outcome in bold) Main objectives: - Prevalence of blood-borne viral infections in Belgian (former or active) PWUD: - HCV infection (number of HCV Ab+ / number of screened PWUD) - HBV infection (number of HBsAg+/number of screened PWUD) - HIV infection (number of HIV Ab+/number of screened PWUD) - Analysis of linkage to care to hepatologist/ infectiologist (number of patients who adhered to their consultation/number of referred patients) Secondary objectives: - Analysis of risk behavior/sociodemographics linked to presence of BBV infections - Analysis of uptake of anti(retro)viral treatment (number of patients started on treatment/number of patients needing treatment) - Analysis of treatment adherence (adherence to treatment consultations/total planned consultations) - Analysis of treatment outcome (total number of cured or virally suppressed patients/total number of treated patients)

NCT ID: NCT04352309 Completed - Clinical trials for Hepatitis C Virus (HCV)

Efficacy Study Of Oral Glecaprevir/Pibrentasvir Tablet In Pediatric (12 Years and Older) And Adult Treatment-Naive Participants With Chronic Hepatitis C Genotypes 1 To 6 And Liver Cirrhosis

EASY
Start date: May 29, 2020
Phase:
Study type: Observational

Hepatitis C Virus (HCV) infection is among the most common of all chronic liver diseases. HCV predominantly affects liver cells and causes the liver to become inflamed and damaged. This can lead to cirrhosis (scarring of the liver) and liver cancer leaving trial participants with need for liver transplant. The purpose of this study is to see how effective Glecaprevir/Pibrentasvir (GLE/PIB) is in a real world setting of participants with chronic HCV genotypes 1 to 6 and liver cirrhosis who have never received any treatment for HCV. GLE/PIB is a drug developed for the treatment of HCV infection. This is a prospective (future), observational study in treatment-naive (those who have not received treatment) participants with HCV genotypes 1 to 6 and compensated cirrhosis. All study participants will receive GLE/PIB as prescribed by their study doctor in accordance with approved local label. Pediatric (12 years and older) and adult participants with a diagnosis of HCV genotypes 1 to 6 and compensated cirrhosis will be enrolled in the study in Russian Federation. Participants will receive GLE/PIB tablets to be taken by mouth daily according to their physicians' prescription. The total duration of the study is 20 weeks, with a treatment period of 8 weeks and a follow up period of 12 weeks. There is expected to be no additional burden for participants in this trial. All study visits will occur during routine clinical practice and participants will be followed for 12 weeks.

NCT ID: NCT04330508 Completed - Clinical trials for Depression in Chronic Hepatitis C

Effects of Direct-acting Antiviral Agents on HCV Cognitive Function, and Depression in HCV Related Cirrhosis: A Prospective Clinical Trial

Start date: March 1, 2018
Phase:
Study type: Observational

Minimal hepatic encephalopathy (MHE) is an important clinical variant of hepatic encephalopathy (HE), which occurs in up to 60-70% of patients with cirrhosis. The condition comprises a cognitive impairment, observed in patients with cirrhosis who have no clinical evidence of overt hepatic encephalopathy (OHE). It is associated with an increased incidence of road traffic accidents, reduced quality of life and it affects the ability to perform tasks of daily living. Successful treatment of hepatitis C has been reported to be associated with 62-84% reduction in all-cause mortality (deaths), 68-79% reduction in risk of HCC and 90% reduction in risk of liver transplantation. In addition, studies have shown that viral eradication may improve cognition when given interferon based regimens for HCV. With the available of safe, efficacious, all oral regimens for HCV, we plan to prospectively analyse the change in mood, depression and cognitive function in response to DAA therapy, in relation to outcomes of treatment.