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Hepatitis clinical trials

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NCT ID: NCT03643172 Recruiting - Clinical trials for Chronic Hepatitis B, HBeAg Negative

Terminator 2 Register

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

All patients with chronic HBeAg negative hepatitis B treated with nucleos(t)ide analogues, who discontinue treatment based in the criteria outlined in the EASL hepatitis B guidelines shall be included in the present study. The aim is to evaluate the clinical outcome (virological relapse, HBsAg decline) and associated virological and immunological parameters.

NCT ID: NCT03640728 Recruiting - Hepatitis B Clinical Trials

The Efficacy and Safety of Nucleos(t)Ide Analogues in the Treatment of HBV-related Acute-on-chronic Liver Failure

Start date: January 25, 2019
Phase:
Study type: Observational

HBV-related acute-on-chronic liver failure (ACLF) is a clinical syndrome defined as acute hepatic insult with diagnosed or undiagnosed chronic liver disease. Current clinical guidelines advocate oral antiviral treatment in HBV-related ACLF. However, no conclusion on which nucleoside analogue is the most satisfactory drug for the treatment of HBV-related liver failure has not been reached yet. In this cohort study, the investigators will compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF), Tenofovir Disoproxil Fumarate (TDF) and entecavir (ETV) in HBV-related ACLF in China. In addition, the drug metabolism characteristics of TAF will be explored in such severe liver injury population of HBV-ACLF.

NCT ID: NCT03638076 Completed - Chronic Hepatitis B Clinical Trials

The Safety, Antiviral Activity, and Pharmacokinetics of Morphothiadine Mesilate Capsules

Start date: July 26, 2017
Phase: Phase 2
Study type: Interventional

The Safety, Antiviral Activity, and pharmacokinetics of Morphothiadine Mesilate Capsules/Ritonavir Tablets in Patients with Chronic Hepatitis B

NCT ID: NCT03627819 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Plant Sterols and Plant Stanols and Liver Inflammation

Start date: May 4, 2018
Phase: N/A
Study type: Interventional

As the prevalence of obesity is reaching epidemic proportions, the prevalence of non-alcoholic fatty liver disease (NAFLD), including non-alcoholic steatohepatitis (NASH), increases concomitantly and becomes a major global health hazard. Successful pharmacological interventions to treat or prevent NASH are not available and so far only weight loss has clear benefits, but sustained weight-loss is difficult to achieve on the longer-term. We recently demonstrated in mice that plant sterol and stanol ester consumption inhibited the development of liver inflammation, which needs to be validated in humans in a translational approach. In the current proposed pilot study, the effect of consuming plant sterol or plant stanol esters on biopsy proven liver inflammation will be investigated in NAFLD patients. The objective is to assess the effect of consuming plant sterol or plant stanol esters (3 grams/day) for 12 months on biopsy proven liver inflammation in NAFLD patients. This study is a randomized, placebo-controlled, double blinded pilot study with a run-period of 2 weeks, an intervention period of 12 months and a wash-out period of 1 month. The study population consists of 15 patients with biopsy-proven liver inflammation, aged 18-75 years. All subjects will start a run-in period of two weeks during which they consume daily 20 grams of control margarine after which they will be randomly allocated to consume 20 grams control margarine or plant sterol or plant stanol enriched margarine on a daily basis for a period of 12 months. The primary outcome parameter in this study is biopsy proven liver inflammation.

NCT ID: NCT03627507 Completed - Clinical trials for Hepatitis B Infection

Non Inferiority Trial of Locally Manufactured 'Hepa-B' Vaccine in Bangladesh.

Start date: July 29, 2018
Phase: Phase 2/Phase 3
Study type: Interventional

Hepatitis B is a common and serious infectious disease of the liver, affecting millions of people throughout the world. Persistent Hepatitis B virus infections may cause development of chronic hepatic insufficiency, cirrhosis and hepatocellular carcinoma. Adding to that, Hepatitis B Virus carriers can transmit the disease for many years. It is transmitted through blood or other body fluids infected with the Hepatitis B virus. It is a major cause of morbidity and mortality in countries like Bangladesh. Immunization with Hepatitis B vaccine has been proved effective to prevent HBV infection. But the vaccines, which are recommended till now, are expensive. Locally manufactured Hepatitis B vaccine will be safe, cost effective and affordable for all. The test vaccine will induce similar seroprotection rates to hepatitis B one month post-vaccination and at 7 months, one month after the third dose of vaccine compared to reference vaccine. This will be done by comparing the percentages of participants with ≥10 mIU/ml anti-HBs by vaccinated with either Hepa B or Engerix B vaccine. The non-inferiority margin will be 10%.

NCT ID: NCT03627299 Completed - Hepatitis C Clinical Trials

Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors

Start date: September 25, 2018
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 glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 4 weeks post-renal transplant.

NCT ID: NCT03625687 Terminated - Hepatitis C Clinical Trials

Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Lung Transplant

Start date: February 5, 2019
Phase: Phase 4
Study type: Interventional

This is a proof of concept, single center study for the donation of HCV-positive lungs to HCV negative recipient patients, with preemptive, interventional treatment with 8 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

NCT ID: NCT03623568 Withdrawn - Hepatitis C Clinical Trials

Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant

Start date: February 15, 2019
Phase: Phase 4
Study type: Interventional

This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

NCT ID: NCT03620474 Completed - Hepatitis C Clinical Trials

Safety and Effectiveness of PRI-724 for Hepatitis C or B Virus Derived Liver Cirrhosis

Start date: July 24, 2018
Phase: Phase 1/Phase 2
Study type: Interventional

To investigate the safety and efficacy of PRI-724 against HCV or HBV liver cirrhosis.

NCT ID: NCT03619590 Completed - Hepatitis Clinical Trials

Twinrix Pregnancy Registry

Start date: May 18, 2001
Phase:
Study type: Observational [Patient Registry]

The purpose of the Twinrix Pregnancy Registry is to prospectively collect data describing exposure to Twinrix before or during pregnancy, potential confounding factors (such as exposure to other medications) and information related to the outcome of the pregnancy. This is a prospective, voluntary, observational, exposure-registration study. Twinrix is designated as Food and Drug Administration (FDA) Pregnancy Category C, which means that its safety in human pregnancy has not been determined. The Registry is intended to provide an early signal of potential risks in advance of results from formal epidemiologic studies. Registry statistics can supplement animal reproductive toxicology studies and assist clinicians in evaluating the potential risks and benefits of vaccination for individual patients.