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Hepatitis, Chronic clinical trials

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NCT ID: NCT03604016 Not yet recruiting - Hepatitis B Clinical Trials

Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver

Start date: September 23, 2018
Phase: Phase 4
Study type: Interventional

Pilot study to assess the antiviral activity and safety of Besifovir dipivoxil 150mg and L-carnitine 660mg compared to Tenofovir Alafenamide 25mg in chronic hepatitis B patients with Nonalcoholic fatty liver

NCT ID: NCT03566030 Not yet recruiting - Hepatitis B Clinical Trials

Switching From Tenofovir Disoproxi Fumarate to Tenofovir Alafenamide in Chronic Hepatitis B Patients With Antiviral Resistance

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

- To evaluate the efficacy of switching to tenofovir alafenamide (TAF) 25 mg QD versus continued tenofovir disoproxil fumarate (TDF) 300 mg QD in CHB patients with antiviral resistance, as determined by the proportion of virologically suppressed patients at week 48 - To evaluate the safety and tolerability of switching to TAF 25 mg QD versus continuing TDF 300 mg QD in antiviral-resistant subjects with chronic HBV at week 48

NCT ID: NCT03495570 Not yet recruiting - Chronic Hepatitis C Clinical Trials

Sysmex-XN 20 Analyser to Assess Lymphocyte Subsets and Other Haematological Parameters in Chronic/Acute Viral Infections

SASA
Start date: April 15, 2018
Phase:
Study type: Observational

The XN-20, is a full blood count (FBC) analyser with an extended differential counting and flagging System. The XN-Series' individual channels allow real-time reflex analysis, and uses a two stage process to classify the white blood count (WBC) sub-populations and detect the presence of abnormal reactive and malignant cells. In regards to lymphocytes in the peripheral blood, the machine has the capacity to distinguish activated from non-activated T-cell subsets using a very small volume of EDTA sample (88uL) (including remnant sample from a standard full blood count) with results available in 1.5 minutes. It is a fully automated process and can be considered as an alternative rapid flow cytometry method. Objective of the SASA study: to investigate the signal pattern of white blood cells assessed using the XN-20 full blood count platform in patients with untreated viral infections i.e. HIV, HCV and HBV. The data from the analysis will be reviewed in conjunction with patient's demographic and clinical disease characteristics with the aim of detecting characteristic cell populations that can be used in the development of system flags for future studies.

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: NCT03349008 Not yet recruiting - Chronic Hepatitis b Clinical Trials

Magnesium Isoglycyrrhizinate Followed by Diammonium Glycyrrhizinate and Combined With Entecavir in Chronic Hepatitis B

MAGIC-101
Start date: November 25, 2017
Phase: Phase 4
Study type: Interventional

This study evaluates the addition of glycyrrhizin to entecavir in the treatment of patients with chronic hepatitis B in China. Half of participants will receive magnesium isoglycyrrhizinate followed by oral diammonium glycyrrhizinate and entecavir in combination, while the other half will receive a placebo and entecavir.

NCT ID: NCT03308890 Not yet recruiting - Chronic Hepatitis B Clinical Trials

The Effect of Entecavir Consolidation on Post-TDF Treatment Durability

Start date: November 1, 2017
Phase: Phase 4
Study type: Interventional

Clinical relapse occurred much earlier and tended to be more severe after cessation of TDF than ETV. The follow-up interval and intensity would be different between ETV and TDF after discontinuation of therapy. Whether switch therapy from TDF to ETV can modify the pattern of relapse is interesting but unclear. Our hypothesis is that entecavir consolidation on post-TDF treatment patients reduce and delay the clinical relapse effectively. Hence in this proof of concept study we would like to evaluate the effect of 6 months and 12 months of entecavir consolidation on post-TDF treatment durability.

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 .