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Hepatitis clinical trials

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NCT ID: NCT02937779 Active, not recruiting - Pregnancy Clinical Trials

Tenofovir As Prevention Of Hepatitis b Mother-to-child Transmission

TA-PROHM
Start date: October 4, 2017
Phase: Phase 4
Study type: Interventional

The World Health Organization recommends that all high endemic countries for HBV infection based their mother to child transmission prevention strategies on vaccination of all children and administration of immunoglobulins (HBIG) to infants born to infected mothers in the first 24 hours after birth. Lack of access to antenatal screening and to HBIG significantly results in failure of this strategy in many countries. Moreover, despite sero-vaccination, 10 to 15% of infants of mothers that are positive for HBsAg and HBeAg are still infected, as high levels of HBV replication occurring in the third quarter of pregnancy act as a major risk factor. The objective of this study is to assess the effectiveness of an operational strategy to prevent HBV mother-to-child transmission (MTCT) in Cambodia based on the use of rapid tests HBs Ag and HBe Ag to screen HBV infection and a treatment by TDF for patients with a positive HBeAg test with a "test and treat" strategy for those seen for Antenatal Care (ANC) from 24 weeks of amenorrhea. In all cases, vaccination of the newborn will be carried out according to the national protocol in Cambodia i.e. 4 injections at 24 hours, 6, 10 and 14 weeks of age. A phase IV multicenter observational and interventional non randomized prospective study will be conducted in 4 maternity in Cambodia. The primary outcome will be the proportion of active HBV infection in new-born at 6 months of life estimated by HBs Ag positivity. The study will aim to document the acceptability and the operational implementation of the study using rapid tests usable in all health centers and a drug available in all the country thanks to HIV national program. The results will be helpful for Cambodian government in order to implement guidelines and algorithm follow-up for HBV-infected pregnant women.

NCT ID: NCT02936648 Completed - Hepatitis C Clinical Trials

Hepatitis C Testing in VA Community-Based Outpatient Clinics

HCVCBOC
Start date: October 2015
Phase: N/A
Study type: Interventional

The VISN1 VA Hepatitis C Testing and Linkage to Care Quality Improvement project aims to increase the proportion of Veterans tested for HCV in those born between 1945-1965 and in vulnerable, high-risk groups.

NCT ID: NCT02936596 Recruiting - Cholestasis Clinical Trials

Remission Induction of Primary Biliary Cholangitis-autoimmune Hepatitis Overlap Syndrome

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

Biochemical response of primary biliary cholangitis-autoimmune hepatitis overlap syndrome induced by ursodeoxycholic acid only or combination therapy of immunosuppressive agents

NCT ID: NCT02932150 Recruiting - Chronic Hepatitis B Clinical Trials

Study of Tenofovir Alafenamide (TAF) in Children and Teen Participants With Chronic Hepatitis B Virus Infection

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

The goals of this clinical study are to compare the effectiveness, safety and tolerability of study drug, tenofovir alafenamide (TAF), versus placebo in teens and children with CHB and to learn more about the dosing levels in children.

NCT ID: NCT02931513 Recruiting - Clinical trials for Primary Biliary Cirrhosis

sCD163 in PBC Patients - Assessment of Treatment Response

Start date: September 2016
Phase:
Study type: Observational

Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by destruction of the small intrahepatic bile ducts. Ursodeoxycholic acid (UDCA) is the first line treatment for patients with PBC. However, up to 40% of patients respond inadequate to this treatment. sCD163 is a macrophage activation marker shedded into plasma by macrophages in the liver. sMR is a soluble mannose receptor. The investigators want to investigate whether sCD163 and sMR can predict response to treatment with UDCA in newly diagnosed patients with PBC.

NCT ID: NCT02924701 Active, not recruiting - Clinical trials for Primary Biliary Cirrhosis

sCD163 in PBC Patients - Assessment of Disease Severity and Prognosis

Start date: September 2016
Phase:
Study type: Observational

Primary biliary cholangitis (PBC) is an autoimmune chronic liver disease, characterised by destruction of the small intrahepatic bile ducts. sCD163 is a macrophage activation marker shedded into plasma by macrophages in the liver. sMR is a soluble mannose receptor. The investigators want to investigate whether sCD163 and sMR correlate with disease severity in patients with PBC, and whether sCD163 and sMR can predict short term disease progression, changes in quality of life and death in these patients.

NCT ID: NCT02920931 Completed - Hepatitis Clinical Trials

A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers

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

A Randomized, Open-label, Single-dosing, 2X2 Crossover Study to Compare the Safety and Pharmacokinetics of BR-TND Tablet(Tenofovir Disoproxil) With Viread Tablet(Tenofovir Disoproxil Fumarate) in Healthy Male Volunteers.

NCT ID: NCT02909023 Completed - Hepatitis B Clinical Trials

Performance of the HBV ELISPOT in the Detection of the T Cellular Immune Response in Patients Infected by HBV or Cured

Start date: July 2016
Phase: N/A
Study type: Observational

Activation of the immune system against a pathogen can be considered one of the most effective interventions in the field of infectious diseases. Transgene is developing a therapeutic vaccine "TG1050" for the treatment of patients with chronic and treated Hepatitis B. This biotherapy compound is for the development of T cellular immune response in these patients in order to achieve the total elimination of infected cells. Therefore it is necessary to have measures of ways to assess accurately and reliably the presence of such a response in the study subjects.

NCT ID: NCT02908763 Recruiting - Chronic Hepatitis B Clinical Trials

HBsAg Loss/Seroconversion in Low Replicative Chronic Hepatitis B Virus(HBV) Infection Patients

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

HBsAg Loss/Seroconversion is uncommon in Low replicative chronic HBV infection patients. The purpose of this study is to investigate the ability of peginterferon alpha to achieve HBsAg loss/seroconversion therapy in Low replicative chronic HBV infection patients with Low Level HBsAg.

NCT ID: NCT02908191 Completed - Chronic Hepatitis B Clinical Trials

A Study in Healthy Volunteers and Patients With Chronic Hepatitis B

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

This two-part, Phase 1 protocol will be the first clinical study of ABI-H0731. Part I will be a Phase 1a dose-ranging assessment of ABI-H0731 in healthy adult volunteers. If the dose-related safety, tolerability and pharmacokinetics (PK) of ABI-H0731 in human volunteers are deemed satisfactory, then the study will advance to Part II, a Phase 1b dose-ranging assessment of ABI-H0731 in non-cirrhotic, CHB patients.