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Hepatitis C, Chronic clinical trials

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NCT ID: NCT03476031 Not yet recruiting - Clinical trials for Cryoglobulinaemia Due to Chronic Hepatitis C

Pathology of Hepatitis c Nephropathy

Start date: November 2018
Phase:
Study type: Observational

Hepatitis c associated glomerulonephritis is an immune complex disease that occurs in 21% of patients who have HCV infection.

NCT ID: NCT03461250 Not yet recruiting - HCV Infection Clinical Trials

Chronic Hepatitis C in Chronic Hemodialysis Recipients - An Observational Study

(CHINCHERO)
Start date: April 1, 2018
Phase:
Study type: Observational [Patient Registry]

This is an observational study of cases of chronic hepatitis C and negative HCV controls in adults receiving chronic hemodialysis at the National Renal Health Center (NRHC) -EsSalud in Lima - Peru.The NRHC provides specialized health care, including hemodialysis, to people with advanced kidney disease from all the districts of Lima. Study population: By December 2017, there were 293 adults receiving chronic hemodialysis at the NRHC-EsSalud. All adult patients receiving chronic hemodialysis at the NRHC-EsSalud will be invited to participate. Primary objective: Characterize HCV disease in patients receiving chronic hemodialysis at the NRHC-EsSalud. Secondary objective: Identify factors associated with an increased risk of HCV infection. Inclusion criteria: Age > 18 years Receive chronic hemodialysis (for at least 6 consecutive months) at the NRHC. Exclusion criteria: • Inability to provide informed consent. To comply with the primary objective of the study, samples from volunteers with HCV serology confirmed in Roe Clinic Laboratory (cases) will be subjected to additional tests: HCV viral load followed by determination of the HCV genotype by using the Abbott m2000 real-time PCR system capable of identifying genotypes 1 (1a and 1b), 2, 3, 4 , 5 and 6, using fluorescent probes of oligonucleotides specific for each genotype . In addition to these lab tests, volunteers will have a Fibroscan test performed at a local provider, with the Fibroscan Model 402 with E and XL probes. The information will be collected in a Case Report Form (CRF), which will be filled out by study staff. The source of clinical information will be primarily the clinical history of the NRHC - EsSalud. The source of information on the results of the auxiliary tests will be obtained from the results issued by Roe Clinic Laboratory and by the image center of the Delgado Clínic. Protection of Human Subjects: The protocol and informed consent will be reviewed and approved by the Ethics Committee of the NRHC. No study procedure will be carried out if the volunteer has not given his or her written consent. All reasonable precautions will be taken to protect the privacy of the volunteer's information, whose data will be identified only through a code. Researchers will keep the study folders in a locked cabinet in a safe place

NCT ID: NCT03268317 Not yet recruiting - Hepatitis C Clinical Trials

Neuropsychiatric Adverse Effects in Patients With Chronic Hepatitis C Treated by Direct Acting Antiviral Drugs

Start date: January 2018
Phase: N/A
Study type: Observational

Neuropsychiatric adverse effects of direct acting antiviral drugs, especially Sofosbuvir and Daclatasvir combination therapy (with or without ribavirin) in patients with chronic hepatitis C , genotype four (the predominant genotype in Egypt).

NCT ID: NCT03222167 Not yet recruiting - Metabolic Syndrome Clinical Trials

Open-Label Efficacy and Safety Study of the Elbasvir/ Grazoprevir Fixed Dose Combination Patients With Chronic HCV GT1b

Start date: October 2017
Phase: Phase 3
Study type: Interventional

This is a multi-center, open-label trial of Elbasvir/ Grazoprevir 50/100 mg fixed dose combination 12 week treatment aimed to evaluate SVR12 in treatment naïve patients with chronic hepatitis C (genotype 1b) infection, associated with of metabolic syndrome. The study to be conducted in conformance with Good Clinical Practices. A total of 60 subjects will be studied at 2 sites in the Republic of Kazakhstan. Males and Females treatment naïve patients with CHC genotype 1b infection associated with metabolic syndrome (MS), 18-70 years of age, with or without severe fibrosis / compensated cirrhosis will be enrolled. SVR 12 (primary endpoint) will be evaluated. Patients will be stratified by fibrosis stage and presence of metabolic syndrome components. Interim Analysis will be performed in order to estimate viral kinetics, applicability of SVR4 and durability of SVR12 by evaluation of virologic response at week 4 and 8 of treatment and follow-up at week 4 (SVR 4) and 24 will be performed - this will be a descriptive summary only without hypothesis testing. The main hypothesis is that 12-week therapy with MK-5172 in combination with MK-8742 for treatment-naïve patients with HCV genotype 1b with metabolic syndrome is not notably worse than the same course for treatment-naïve patients with HCV genotype 1b without metabolic syndrome.

NCT ID: NCT03170076 Not yet recruiting - Clinical trials for Hepatitis C, Chronic

Pattern of Skin Manifestations in Chronic Hepatitis c Virus Patients Before and After Direct Acting Anti Viral Drugs

Start date: July 2017
Phase: N/A
Study type: Observational

- Hepatitis C is an infectious disease caused by the hepatitis C virus (HCV) that primarily affects the liver. It is one of the main causes of chronic liver diseases worldwide . - According to World Health Organization (WHO), 2011 , Egypt has particularly high rates of Hepatitis C (22%). - Hepatitis C virus (HCV) is known to induce both hepatic and extra-hepatic manifestations. About 17% of HCV patients present with at least one skin manifestation, which can be directly or indirectly induced by chronic HCV infection .

NCT ID: NCT02950870 Not yet recruiting - Clinical trials for Chronic Hepatitis, C Virus

Efficacy Study to Evaluate the Effect of New Antiviral Drugs on HCV Infection.

Start date: December 2016
Phase: Phase 4
Study type: Interventional

The purpose of this study is to determinate the AMH levels before and after antiviral therapy with Ombitasvir-Paritaprevir-Ritonavir and Dasabuvir in comparison with age-matched HCV-positive women not undergoing antiviral treatment.

NCT ID: NCT02865369 Not yet recruiting - Chronic Hepatitis C Clinical Trials

Regression of Liver Fibrosis After Daclatasvir and Asunaprevir Treatment

RELIF-C
Start date: September 2016
Phase: N/A
Study type: Observational [Patient Registry]

A study on regression of liver fibrosis assessed by transient elastography after Daclatasvir and Asunaprevir combined treatment in advanced fibrotic/cirrhotic patients with chronic hepatitis C genotype 1b Infection

NCT ID: NCT02745132 Not yet recruiting - Hepatitis C Clinical Trials

Cognitive Impairments in Chronic Hepatitis C Patients and Potential Reversibility With New Agents (CICHepC)

CICHepC
Start date: June 2016
Phase: Phase 4
Study type: Interventional

The overall aim of this study is to evaluate the prevalence of cognitive impairments and brain anomalies in Chronic Hepatitis C infected individuals and to investigate likely changes in cognition and brain structure and function after treatment with Direct-acting Antivirals (DAAs).

NCT ID: NCT02691728 Not yet recruiting - Chronic Hepatitis C Clinical Trials

Study to Investigate the Efficacy and Safety of Ledipasvir/Sofosbuvir Fixed-Dose Combination for 12 Weeks in Subjects With Chronic Genotype 1 and 4 HCV Infection With Autoimmune Disease

Start date: February 2016
Phase: Phase 4
Study type: Interventional

This study is evaluating the safety and efficacy of a 12 week treatment LDV/SOF FDC in patients with Chronic GT1 or GT4 HCV infection and autoimmune disease

NCT ID: NCT02617615 Not yet recruiting - Chronic Hepatitis C Clinical Trials

A Trial to Evaluate Safety, Tolerability, PK and Antiviral Activity of MB-110 in Hepatitis C Virus Infected Patients

Start date: December 1, 2017
Phase: Phase 1
Study type: Interventional

A Phase 1, First-in-Human, Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Safety, Tolerability, and Pharmacokinetic Profiles of Single Ascending and Multiple Oral Doses of MB-110 in Healthy Volunteers and to Evaluate the Antiviral Activity of MB-110 in Hepatitis C Virus Infected Subjects