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Hepatitis C, Chronic clinical trials

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NCT ID: NCT03155906 Active, not recruiting - Clinical trials for Hepatitis C, Chronic

Integrated Treatment of Hepatitis C Virus Infection

INTRO-HCV
Start date: May 18, 2017
Phase: N/A
Study type: Interventional

INTRO-HCV is a multicentre randomised controlled clinical trial that will compare the efficacy of integrated treatment of chronic hepatitis C virus infection (HCV) within medically assisted rehabilitation (MAR) clinics providing opioid substitution therapy (OST) compared to standard treatment. The trial will recruit approximately 250 HCV infected in Bergen and Stavanger and about 1000 in a linked observational study. Intervention: Integrating diagnostic and treatment follow-up for HCV treatment into MAR outpatient clinics in Bergen and Stavanger including testing for HCV, counselling and treatment evaluation and treatment delivery. Primary objectives: Compare the effect of integrated HCV treatment assessed with sustained virological response at 12 weeks between the MAR outpatient clinics in Bergen and Stavanger (intervention arm) with standard treatment provided after referral to infectious disease clinics among patients who receive OST having HCV Secondary objectives: Compare treatment adherence between the intervention and control arms, and assess changes in quality of life, fatigue and psychological well-being before and after HCV treatment, as well as changes in drug use, infection related risk behavior, and risk of reinfection among those with sustained virological response. Main endpoint: Sustained virological response of HCV at 12 weeks (± 10 days) Study population: The target group will be patients receiving care with MAR from involved outpatient clinics in Bergen, Sandnes and Stavanger who are chronically infected with HCV and eligible for treatment according to national guidelines. Study duration: Participants will be included and followed up at least annually for the total study duration between 2017 and 2021. Expected outcome: This study will inform on the relative advantages and disadvantages of an integrated treatment program for HCV into MAR compared to standard care aiming to increase access to treatment and improved treatment adherence. If the integrated treatment structure is found to be safe and efficacious, it can be considered for further scale-up.

NCT ID: NCT02897596 Active, not recruiting - HIV Clinical Trials

Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients

EARLY-HEP-C
Start date: April 28, 2017
Phase: Phase 3
Study type: Interventional

Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients.

NCT ID: NCT02772003 Active, not recruiting - Clinical trials for Hepatitis C Infection

DNA Vaccine Therapy in Treating Patients With Chronic Hepatitis C Virus Infection

Start date: June 6, 2016
Phase: Phase 1
Study type: Interventional

This phase I trial studies the side effects and best dose of deoxyribonucleic acid (DNA) vaccine therapy in treating patients with hepatitis C virus (HCV) infection that persists or progresses over a long period of time. Vaccines made from DNA may help the body build an effective immune response to kill cancer cells that express HCV infection.

NCT ID: NCT02371408 Active, not recruiting - Chronic Hepatitis C Clinical Trials

A Study of the Efficacy and Safety of PPI-668 (NS5A Inhibitor) Plus Sofosbuvir, With or Without Ribavirin, in Patients With Chronic Hepatitis C Genotype-4

Start date: January 2015
Phase: Phase 2/Phase 3
Study type: Interventional

The study will assess the efficacy of PPI-668 (USAN: ravidasvir hydrochloride) in combination with sofosbuvir, with or without ribavirin, in the following Egyptian HCV gt-4 patient populations: 1. Treatment-naïve patients, with and without cirrhosis (Group 1) 2. Previous non-responders to interferon-based therapies, without cirrhosis (Group 2) 3. Previous non-responders to interferon-based therapies, with cirrhosis (Group 3)

NCT ID: NCT02108301 Active, not recruiting - Clinical trials for Renal Transplantation

Hepatitis C in Renal Transplant Recipients

Start date: December 2011
Phase: Phase 4
Study type: Interventional

The aim of the present trial is to evaluate whether the conversion of immunosuppression from tacrolimus to cyclosporine A induces changes in (i) hepatitis C-virus load, (ii) parameters of hepatic function and (iii) parameters of glucose tolerance in hepatitis C-positive renal transplant recipients.

NCT ID: NCT02031133 Active, not recruiting - Hepatitis C Clinical Trials

Long-term Extension to Miravirsen Study in Null Responder to Pegylated Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C

Start date: January 2014
Phase: Phase 2
Study type: Observational

Study SPC3649-207E is designed as an extension study to the prior protocol to provide additional long-term safety and efficacy information for subjects participating in Study SPC3649-207.

NCT ID: NCT02011932 Active, not recruiting - Liver Cirrhosis Clinical Trials

Prospective Observational Study of Disease Progression in Chronic Hepatitis C

Start date: July 2010
Phase: N/A
Study type: Observational

The purpose of this study is to determine the progression of chronic hepatitis C patients infected by paid plasma donation,and explore the possible pathogenic mechanisms of disease progression in chronic hepatitis C.

NCT ID: NCT01900886 Active, not recruiting - Clinical trials for Hepatitis C, Chronic

Epidemiological Study to Evaluate Personality Disorders in Prison Populations in Treatment for Hepatitis C

Perseo
Start date: December 2010
Phase: N/A
Study type: Observational

Primary objective: Evaluate the prevalence of personality disorders in patients starting treatment for hepatitis C in the prison and determine their influence on the evolution of the disease.

NCT ID: NCT01872936 Active, not recruiting - Clinical trials for Hepatitis C, Chronic

Miravirsen in Combination With Telaprevir and Ribavirin in Null Responder to Pegylated-Interferon Alpha Plus Ribavirin Subjects With Chronic Hepatitis C Virus Infection

Start date: June 2013
Phase: Phase 2
Study type: Interventional

The purpose of this open-label study is to assess the safety, tolerability, antiviral activity, genotype resistance associated with virological failure, pharmacokinetics and pharmacodynamics of two dose regimens of miravirsen in combination with telaprevir and ribavirin in subjects with hepatitis C virus genotype 1 infection who are null responder to pegylated-interferon alpha and ribavirin.

NCT ID: NCT01743521 Active, not recruiting - Clinical trials for Early Chronic Hepatitis C

DAA Based Therapy for Recently Acquired Hepatitis C (DARE-C)

DARE-C
Start date: January 2013
Phase: Phase 4
Study type: Interventional

To examine the safety and efficacy of response guided triple therapy (PEG-IFN, Ribavirin, Telaprevir) for the treatment of early chronic HCV infection.