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HBV clinical trials

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NCT ID: NCT02454764 Withdrawn - HBV Clinical Trials

'Tenofovir Pulse and Peg Interferon Alpha 2b' Therapy in HBeAg-positive Patients With Normal ALT

Start date: n/a
Phase: N/A
Study type: Interventional

After fulfillment of the selection criteria, all the patients included in the trial will be administered Tenofovir that will be continued for 3 months and then stopped for 1 month, LFT's, HBV DNA, HBsAg, will be checked weekly during the time period of stopping Tenofovir and thereafter at 4 months patients with ALT >/= 1.5 times ULN will be randomised in 2 groups to administer either Peg INF alpha 2b + Tenofovir (in same dose as before) or Tenofovir alone which will be continued for 48 weeks and the patients with no rise in ALT will be excluded. Patients will be closely monitored during the period of stopping tenofovir post pulse therapy and liver function tests will be performed weekly. Patients will be closely observed for the development of acute hepatitis or decompensation during the 4 - week period of drug withdrawal. Thereafter, CBC, KFT, LFT's, PT-INR, HBsAg (Q), HBeAg and HBV DNA levels will be tested every 3 months. After stopping treatment followup will be done at 24 weeks post stoppage of treatment to look for sustained seroconversion and virological/biochemical response

NCT ID: NCT02434848 Completed - HIV Clinical Trials

A Pilot Study Comparing the Immunogenicity of Fendrix vs. Double-dose Engerix B in HIV-infected Non-responders to Standard Hepatitis B Vaccination Courses

Start date: July 23, 2015
Phase: Phase 2/Phase 3
Study type: Interventional

Hepatitis B virus (HBV) infection can result in a greater risk of adverse outcomes in HIV-infected individuals, including more rapid progression to cirrhosis and associated complications such as hepatocellular carcinoma. For this reason, as well as the shared routes of transmission between the two viruses, UK and International guidance recommends that all HBV-negative HIV-infected individuals be offered vaccination against HBV. Unfortunately, response rates in this population can be as low as 17.5 - 40% to standard vaccination courses. To improve this response, strategies such as the use of double dose of standard vaccines (e.g. Engerix B) is recommended in several guidelines for previous non-responders, although there is currently limited evidence for this approach. An alternative strategy is to use vaccines with novel adjuvants such as Fendrix and observational clinical data in the Investigators HIV cohort suggests that response rates can be as high as 81% of individuals achieving HBV surface antibody (HBsAb) levels >100 in a group that did not respond to previous standard HBV vaccine courses. However, the cost of Fendrix is considerably higher than Engerix B and controlled trials are required to confirm whether this approach is warranted. Furthermore, insights into the potential mechanisms by which Fendrix may elicit better responses would be valuable in optimising future vaccine strategies in this population. The Investigators propose to conduct a randomised, open label, active-controlled pilot study comparing double dose Engerix B and Fendrix in HIV-infected non-responders to standard HBV vaccine courses, which will provide the necessary data to design and power a larger multicentre randomised controlled trial. Outcome measures will include the proportion of individuals seroconverting with HBsAb levels >100 following each vaccination course, the magnitude and quality of the HBV-specific CD4+ T-cell responses elicited by each vaccine and the durability of the HBsAb response at 1 year following the end of vaccination.

NCT ID: NCT02344680 Active, not recruiting - Clinical trials for Hepatocellular Carcinoma

Liver Fibrosis in Zambian HIV-HBV Co-infected Patients

Start date: October 2015
Phase:
Study type: Observational

In this study the investigators will determine risk factors for liver fibrosis among HIV-HBV co-infected patients in Lusaka, Zambia, and assess the long-term effectiveness of antiretroviral drugs in the prevention and/or reduction of liver disease.

NCT ID: NCT02312531 Completed - HBV Clinical Trials

Prevention for Mother-to-infant Transmission of HBV

Start date: May 2012
Phase: N/A
Study type: Interventional

In this study, HBV-infected pregnant women were divided into two groups, those who received and those who did not receive hepatitis B immunoglobulin (HBIG) during pregnancy. In the mothers, the changes in HBV serum markers (hepatitis B surface antigen (HBsAg), hepatitis B surface antibody (HBsAb), HBeAg, hepatitis B core antibody (HBcAb)), and the DNA load were investigated. Immunohistochemical staining with custom-made antibodies against HBIG revealed both the level and distribution of HBIG in placentas. The protective mechanism of HBIG administrated during pregnancy was explored.

NCT ID: NCT02086708 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Ultrasound Method to Measure Fibrosis of the Liver in Children

Start date: June 2010
Phase: N/A
Study type: Interventional

HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in pediatric patients with chronic liver disease. Specific Aims: 1. To measure liver stiffness with sonoelastography in adults with suspect diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine clinical care. 2. To assess the sensitivity and specificity of sonoelastography for the detection and staging of liver fibrosis. 3. To obtain sonoelastography values of the liver in healthy children (control subjects).

NCT ID: NCT02071082 Completed - HIV Clinical Trials

Efficacy and Safety of E/C/F/TAF (Genvoya®) in HIV-1/Hepatitis B Co-infected Adults

Start date: February 25, 2014
Phase: Phase 3
Study type: Interventional

This study will assess the efficacy, safety, and tolerability of elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) fixed-dose combination (FDC) in human immunodeficiency virus (HIV)/hepatitis B virus (HBV) coinfected adults. Participants will be enrolled into two cohorts: - Cohort 1: HIV/HBV coinfected adults who are HIV treatment-naive and HBV treatment-naive - Cohort 2: HIV/HBV coinfected adults who are HIV-suppressed

NCT ID: NCT02044068 Completed - HBV Clinical Trials

Hepatitis B Virus Vertical Transmission From HIV-HBV Co-infected Women

Start date: October 2014
Phase: N/A
Study type: Observational

Vertical HIV transmission has been dramatically reduced by the use of combined antiretroviral therapy in HIV-infected pregnant women. Among the most often used drugs, several have dual activity, against HIV and HBV: lamivudine, emtricitabine, tenofovir. Studies about vertical HBV transmission from HIV-HBV co-infected pregnant women are rare in developed countries. The study hypothesis is a major reduction of the risk of HBV vertical transmission.

NCT ID: NCT02039362 Completed - Pregnancy Clinical Trials

Prevention of Hepatitis B Virus Vertical Transmission by Serovaccination and Tenofovir During Pregnancy

Start date: July 2012
Phase: Phase 4
Study type: Interventional

The risk of vertical HBV transmission is related to HBV DNA level in pregnant women, around 30% in women with HBV DNA above 1, 000 000 I.U/mL despite serovaccination of newborns. Using tenofovir DF during the last trimester of pregnancy allows to reduce the risk, but data from Western countries are needed.

NCT ID: NCT01970254 Completed - Cancer Clinical Trials

Widespread vs. Selective Screening for Hepatitis B Infection Prior to Chemotherapy

Start date: June 24, 2013
Phase:
Study type: Observational

This trial studies hepatitis B screening strategies of new cancer patients scheduled to undergo chemotherapy. Patients with cancer and hepatitis B virus infection are at risk of reactivation of infection after chemotherapy. Hepatitis B virus infection reactivation can be prevented by starting antivirals before chemotherapy in patients who are hepatitis B virus infection positive. Hepatitis B screening may help doctors prevent the reactivation of hepatitis B virus infection after chemotherapy.

NCT ID: NCT01747772 Recruiting - Clinical trials for Non-Alcoholic Fatty Liver Disease

Sonoelastography: Ultrasound Method to Measure Liver Fibrosis

Start date: February 2010
Phase: N/A
Study type: Interventional

HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) provide accurate quantitative measurements that can be used to stage liver fibrosis in patients with chronic liver disease. 1. To measure liver stiffness with sonoelastography in adults with suspect diffuse liver disease who will undergo nonfocal liver biopsy as part of their routine clinical care. 2. To assess the sensitivity and specificity of sonoelastography for the detection and staging of liver fibrosis