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Hepatitis C clinical trials

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NCT ID: NCT02782247 Completed - Hepatitis C Clinical Trials

Dynamic Liver Tests in Liver Disease

Start date: May 2016
Phase:
Study type: Observational

Chronic viral hepatitis often leads to liver scarring - cirrhosis. If the virus is eradicated from the liver, the liver scarring and liver function often recovers. In some patients the damage is too severe and recovery does not take place. It is not yet known which patients have liver disease that is too advanced to benefit from therapy nor is it known how fast the recovery occurs. Non-intrusive dynamic liver testing (DLT) may allow us to predict the functionality of the liver post treatment and may guide us in treatment choices - for example patients who are predicted not to recover may be prioritised for transplantation. Indocyanine green (ICG) is a dye solely excreted by the liver into bile and used to measure its dynamic function. Transient elastography is similar to ultrasound and measures the degree of fibrosis within the liver. The investigators hypothesise that the use of non-intrusive dynamic liver testing pre-treatment, will allow us to delineate patients before therapy who will have functional liver recovery following viral eradication. The investigators hypothesise that monitoring changes in liver fibrosis and liver function in patients with historical viral clearance will allow an assessment of the likely speed of recovery of liver fibrosis and function - for example if all patients 5 years after treatment for viral hepatitis induced cirrhosis have 'normal' fibrosis and liver function scores the investigators will be able to conclude that recovery is complete within 5 years. The investigators will perform a study pre and post-treatment assessing liver function using non-intrusive dynamic liver testing in addition to currently-used 'liver function' scoring systems, in a multivariate analysis, to determine whether or not the investigators can identify patients who are will have functional liver recovery post therapy.

NCT ID: NCT02781649 Completed - Hepatitis C Clinical Trials

Exploring Renal Transplants Using Hepatitis C Infected Donors for HCV-negative Recipients

EXPANDER-1
Start date: July 20, 2016
Phase: Phase 4
Study type: Interventional

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include Grazoprevir (GZR) 100 mg/Elbasvir (EBR) 50 mg administered on-call to the operating room for the renal transplant procedure and continued for 12 weeks post-renal transplant.

NCT ID: NCT02781571 Completed - Clinical trials for Hepatitis C Virus Infection

Sofosbuvir/Velpatasvir Fixed Dose Combination in Participants With Chronic Hepatitis C Virus Infection Who Have Received a Liver Transplant

Start date: July 27, 2016
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir /velpatasvir (SOF/VEL) fixed-dose combination (FDC) in participants with chronic hepatitis C virus (HCV) who have received a liver transplant.

NCT ID: NCT02781558 Completed - Clinical trials for Hepatitis C Virus Infection

Efficacy and Safety of Sofosbuvir/Velpatasvir Fixed-Dose Combination (FDC) and Sofosbuvir/Velpatasvir FDC and Ribavirin in Participants With Chronic Genotype 3 HCV Infection and Cirrhosis

Start date: July 29, 2016
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) and SOF/VEL FDC and ribavirin (RBV) for 12 weeks in participants with chronic genotype 3 hepatitis C virus (HCV) infection and compensated cirrhosis.

NCT ID: NCT02773394 Completed - Hepatitis C Virus Clinical Trials

Study to Describe the Actual Situation of Hepatitis C Treatment in Brazil

PICTURE
Start date: April 12, 2016
Phase: N/A
Study type: Observational

The purpose of the study is to describe: 1) the clinical profile, past and current management of participants with hepatitis C in Brazil reference centers; 2) the current situation about demographics characteristics, liver disease progression and clinical outcomes in Brazilian Hepatitis C virus (HCV) participants naive, in treatment and previously exposed to antiviral treatment without sustained virological response (SVR).

NCT ID: NCT02772328 Completed - HIV Clinical Trials

A Peer-based Mobile-health Intervention to Increase Access & Adherence to Hepatitis C Treatment & HIV Viral Suppression

HCV-TTP
Start date: December 19, 2016
Phase: N/A
Study type: Interventional

The purpose of this study is to test an intervention designed to train persons who inject drugs (PWID) and are infected with hepatitis C (HCV) and HIV in communication skills to 1) promote new HCV treatment and care 2) risk reduction and 3) recruit their social network members for HIV and HCV testing and linkage to care.

NCT ID: NCT02768961 Completed - Hepatitis C Clinical Trials

Program of Screening, Prevention and Elimination of Hepatitis C in Penitentiary Institutions in Cantabria (JAILFREE-C)

JAILFREE-C
Start date: May 10, 2016
Phase: Phase 4
Study type: Interventional

The objectives of this study are: 1. To perform a systematic screening and evaluation of the prevalence of infection by hepatitis C virus (HCV), hepatitis B virus (HBV) and human immunodeficiency virus (HIV) in the prison population. 2. To perform an adequate characterization of patients and the characteristics of HCV infection in this population. 3. To evaluate the effectiveness and security in the prison population of an interferon-free antiviral regimen. 4. To evaluate the impact of a strategy of systematic HCV treatment on the rates of persistent infection, reinfection and super-infection in a prison population, in the short, medium and long term.

NCT ID: NCT02765490 Completed - Clinical trials for Hepatitis C, Chronic

Efficacy and Safety of Combinations of AL-335, Odalasvir (ODV) and Simeprevir (SMV) in the Treatment of Chronic Hepatitis C Infection

Start date: November 9, 2016
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the efficacy (proportion of subjects with SVR12), safety, tolerability and pharmacokinetics of an 8- and 6-week treatment regimen of AL-335, odalasvir (ODV) and simeprevir (SMV) in chronic HCV genotype 1, 2, 4, 5 or 6 infected subjects without cirrhosis.

NCT ID: NCT02761629 Completed - Clinical trials for Hepatitis C, Chronic

Efficacy and Safety of Peg-Interferon Alpha-2a Plus Ribavirin in Genotype 1 Chronic Hepatitis C Participants Co-Infected With Human Immunodeficiency Virus

Start date: April 2006
Phase: Phase 4
Study type: Interventional

This randomized, multi-center, Phase IV, comparative study will assess the efficacy and safety of combined peg-interferon alpha-2a (Peg-IFN-Alpha-2A) and ribavirin therapy for 48 or 72 weeks of treatment and 24 weeks of follow-up in participants with Genotype 1 chronic hepatitis C (CHC), co-infected with human immunodeficiency virus type 1 (HIV-1).

NCT ID: NCT02760758 Completed - Hepatitis C Clinical Trials

A Study of CDI-31244: A Novel NNI in HV and HCV Infected Subjects

Start date: April 2016
Phase: Phase 1
Study type: Interventional

This is a First in Human study of orally administered CDI-31244, a non-nucleoside inhibitor (NNI) in healthy volunteers and HCV infected individuals