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Hepatitis C clinical trials

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NCT ID: NCT02744105 Completed - Clinical trials for Beta Thalassemia Major

Effect of Spirulina on Liver Fibrosis by Transient Elastography in Beta Thalassemic Children With Hepatitis C

Start date: December 2015
Phase: N/A
Study type: Interventional

Thalassemics can develop liver fibrosis because of iron overload and hepatitis C infection. The latter is the main risk factor for liver fibrosis in transfusion dependent thalassemics. Excess liver iron is clearly recognized as a co factor for the development of advanced fibrosis in patients with hepatitis virus C infection. Transient elastography (Fibroscan) is a reliable non invasive method for diagnosing as liver fibrosis in thalassemic patients regardless of the degree of iron overload. There is evidence that suggests Spirulina may help to protect against liver damage, cirrhosis and liver failure in those with chronic liver disease.

NCT ID: NCT02743897 Completed - Clinical trials for End Stage Renal Disease

Transplanting Hepatitis C Kidneys Into Negative Kidney Recipients

THINKER
Start date: May 1, 2016
Phase: Phase 1/Phase 2
Study type: Interventional

This study is being conducted to determine safety and effectiveness of transplanting kidneys from Hepatitis C-positive donors into Hepatitis C-negative patients on the kidney transplant waitlist, who will then be treated with the appropriate direct-acting antiviral (DAA) after the single kidney transplantation.

NCT ID: NCT02740556 Completed - Hepatitis C Clinical Trials

Evaluation of HepCure Toolkit to Improve Harvoni Adherence

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

There is limited data outside of clinical trials on adherence to once daily ledipasvir/sofosbuvir regimens. Many patients present with known barriers to medication adherence including untreated psychiatric illness and substance use disorders, cognitive impairment, and low health literacy. The goal of this study is to evaluate the baseline level of adherence to ledipasvir/sofosbuvir in a real-world clinic population and compare this to the level of adherence in patients provided with additional adherence support. Medication adherence in this study will be evaluated using AdhereTech, a wireless pill monitoring device that measures the dosage and time a medication was taken. Using cellular technology, AdhereTech can be used passively to collect data on when a medication is taken, when a refill is needed, and how often the bottle is opened. AdhereTech also can be used actively to monitor adherence and provide feedback to subjects using the device. When actively monitoring, AdhereTech can be set up to provide live feedback to a subject by lighting up, sounding chimes, and sending phone/text/email alerts to remind patients to take their medication (see attached PowerPoint presentation). HepCure is a web-based tool kit in the form of a dashboard for medical providers (MDs and NPs) and an application (or "app") for patients. The app allows patients to become active participants in their treatment by enabling them to set medication reminders, record doses taken, and communicate their adherence to their medical provider using the provider dashboard.

NCT ID: NCT02738333 Completed - Clinical trials for Hepatitis C Virus Infection

Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Participants With Chronic Genotype 2 HCV Infection

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

The primary objectives of this study are to evaluate the antiviral efficacy of therapy with ledipasvir/sofosbuvir (LDV/SOF) fixed-dose combination (FDC) and to evaluate the safety and tolerability of LDV/SOF FDC and sofosbuvir (SOF) + ribavirin (RBV) in participants with chronic genotype 2 hepatitis C virus (HCV) infection.

NCT ID: NCT02738138 Completed - Chronic Hepatitis C Clinical Trials

A Study to Evaluate the Efficacy and Safety of Experimental Drugs ABT- 493/ABT-530 in Adults With Chronic Hepatitis C Virus Genotype 1-6 Infection and Human Immunodeficiency Virus -1 Coinfection (EXPEDITION-2)

EXPEDITION-2
Start date: May 17, 2016
Phase: Phase 3
Study type: Interventional

The purpose of this study is to assess the efficacy and safety of ABT-493/ABT-530 in adults with chronic hepatitis C virus genotype 1-6 infection and human immunodeficiency virus-1 co-infection.

NCT ID: NCT02734173 Completed - Hepatitis C Clinical Trials

Pilot HCV Direct Acting Antiviral Therapy and Metabolism

3D
Start date: July 2015
Phase: Phase 4
Study type: Interventional

There is compelling data supporting the pursuit of research into the effects of HCV antivirals on metabolic homeostasis. As a further rationale and justification, the experience with HIV antiretrovirals has clearly demonstrated that antiviral medications can produce profound changes in glucose metabolism, lipid profile and other measures of metabolic homeostasis. This establishes biological plausibility for this focus of research in HCV. The new knowledge created from this research will: 1. Provide new information on the metabolic effects of the Abbvie 3D HCV antiviral regimen. 2. Provide insight as to whether there are metabolic advantages with RBV-free compared to RBV-containing HCV regimens. This is particularly relevant given the current uncertainty regarding the need for RBV in IFN-free, oral DAA regimens. 3. Provide insight into the impact of cirrhosis on metabolic milieu before, during and after HCV antiviral therapy

NCT ID: NCT02728206 Completed - Clinical trials for Hepatitis C Virus Infection

Sofosbuvir/Velpatasvir Fixed-Dose Combination in HCV-Infected Adults Who Are Undergoing Liver Transplantation

Start date: June 12, 2016
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the antiviral efficacy, safety, and tolerability of sofosbuvir/velpatasvir (SOF/VEL) fixed-dose combination (FDC) in hepatitis C virus (HCV)-infected adults who are undergoing liver transplantation.

NCT ID: NCT02727933 Completed - Hepatitis C Clinical Trials

Postmarketing Surveillance of the Safety and Effectiveness of Daclatasvir and Asunaprevir for the Treatment of Chronic HCV Genotype 1B Infection in the Routine Clinical Practice in Korea

Start date: November 3, 2015
Phase:
Study type: Observational [Patient Registry]

The primary objective of this study is to describe the safety of the combination of Daklinza (daclatasvir) and Sunvepra (asunaprevir) when used for the treatment of chronic hepatitis C (CHC) genotype 1b patients in real-life conditions when used according to its registered indications.

NCT ID: NCT02726022 Completed - Clinical trials for Hepatitis C, Chronic

A Quality of Life Study of Peginterferon Alfa-2a and Ribavirin in Participants With Chronic Hepatitis C (CHC) and Persistently Normal Alanine Aminotransferase (ALT) Levels

Start date: February 2007
Phase: N/A
Study type: Observational

Participants with CHC and normal ALT, who have been under treatment with peginterferon alfa-2a and ribavirin for at least 4 weeks, will be enrolled into this non-interventional, open-label study. The primary aim is to evaluate quality of life according to the Short Form 36 (SF-36) questionnaire, modified for the Greek population.

NCT ID: NCT02725866 Completed - Chronic Hepatitis C Clinical Trials

Real World Evidence of the Effectiveness of Paritaprevir/r - Ombitasvir, ± Dasabuvir, ± Ribavirin in Participants With Chronic Hepatitis C

Start date: April 5, 2016
Phase:
Study type: Observational

The interferon-free combination regimen of paritaprevir/ritonavir/ombitasvir with or without dasabuvir (ABBVIE REGIMEN) ± ribavirin (RBV) for the treatment of chronic hepatitis C (CHC) has been shown to be safe and effective in randomized controlled clinical trials with strict inclusion and exclusion criteria under well-controlled conditions. This observational study is the first effectiveness research examining the ABBVIE REGIMEN ± RBV, used according to the local label, under real-world conditions in Greece in a clinical practice patient population.