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NCT ID: NCT04568265 Recruiting - Hepatitis B Clinical Trials

A Clinical Study of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B

Start date: June 3, 2020
Phase: Phase 2
Study type: Interventional

This study is a multicenter, open-label, phase II clinical study in subjects with chronic hepatitis B (CHB), to characterize the safety, tolerability, pharmacokinetic profile and preliminary anti-hepatitis B virus (HBV) efficacy of APG-1387 in combination with entecavir, and to determine the optimal dose of APG-1387 in combination with entecavir.

NCT ID: NCT04562051 Recruiting - Clinical trials for Kidney Transplantation

Stratified vs Routine Prophylaxis in Living Kidney Transplantation From HBsAg+ Donors to HBsAg- Recipients

Start date: September 10, 2020
Phase:
Study type: Observational [Patient Registry]

This is a multicenter, prospective, observational study to compare the efficacy and safety of stratified prophylaxis based on donors' and recipients' risk factors vs routine prophylaxis bases on clinical experience in living kidney transplantation from HBsAg+ donors to HBsAg- recipients. The follow-up period was 2 years after renal transplantation. The primary outcome was prevention failure of HBV transmission (any one of HBsAg - → +, HBV DNA - → +, HBeAg - → +, HBeAb - → +, HBcAb - → +, active liver function damage and death in the recipient).

NCT ID: NCT04539119 Recruiting - B-cell Lymphoma Clinical Trials

Entecavir and Tenofovir Versus Entecavir in Lymphoma Patients With Positive HBV DNA

Start date: July 3, 2020
Phase: Phase 3
Study type: Interventional

This is a prospective, single-center, open-label, randomized controlled trial aimed to evaluate the efficacy and safety of entecavir and tenofovir versus entecavir alone in the antiviral treatment of HBV DNA positive B-cell lymphoma patients. This study plans to enroll about 120 participants in total. Recruitment will last for 2 years. The study visit will take place on the first day of each cycle of therapy until the end of the treatment. Participants who meet the inclusion/exclusion criteria were randomly assigned to receive entecavir and tenofovir or entecavir alone after signing the informed consent. HBV DNA will be measured before each cycle of chemotherapy or immunotherapy. When the copy count of HBV DNA drops below 1*10^3/L, entecavir single agent will be given orally, until one year after the cycle of therapy. Treatment response will be evaluated routinely after chemotherapy or immunotherapy. Within 2 years after the last participant is enrolled, participants' survival information will collected by telephone and/or clinical visit every 3 months after the last visit (i.e. date and cause of death, subsequent cancer treatment, etc.), if there is no withdrawal of the informed consent form.

NCT ID: NCT04519710 Completed - HBV Clinical Trials

Specific Anti-HBV Vaccine Response After Vaccination in Patients Requiring Anti-CD20 Monoclonal Antibodies

HepB20
Start date: September 15, 2020
Phase: N/A
Study type: Interventional

Vaccination coverage against HBV in France is around 30% in the adult population. Treatment with anti-CD20 is associated with a risk of reactivation of hepatitis B or acute or fulminant hepatitis in first-infected patients. HBV vaccination is recommended as before any anti-CD20 treatment in unimmunized patients. However, there is no recommendation on which vaccination regimen to choose in patients on immunosuppressants / corticosteroids or with inflammatory or autoimmune disease. For patients who have a need for rapid immunosuppressive therapy, the use of a standard vaccination schedule (D0, M1, M6) would be responsible for a loss of chance vis-à-vis the underlying disease with a delay of more than 6 months to start treatment with anti-CD20. An accelerated regimen (D0, D7, D21 and M12) allows healthy adults to obtain very rapid vaccine protection between 77 and 90.8%. The accelerated regimen can also be considered on a case-by-case basis in those adults with neurological pathologies, systemic vasculitis or autoimmune disease and who need to receive anti-CD20 antibodies if the combination of injections over a short period is likely to promote immunization. The advantage of the accelerated regimen is to obtain 4 weeks, after the third dose of vaccine, anti-HBs antibodies at a protective level (> 10 IU / L) in approximately 77 to 90.8% of patients and in the general population. The booster injection at 12 months is essential for long-term protection.

NCT ID: NCT04286347 Terminated - Hiv Clinical Trials

HCV, HBV, HIV Testing During Consultation With Anesthesiologist

SAHARA
Start date: August 5, 2021
Phase: N/A
Study type: Interventional

The aim of the study is to assess the feasibility of HCV, HBV, HIV testing (according to the national guidelines) during consultation with Anesthesiologist before a planned surgery in Lariboisiere Hospital, Paris, France. The feasibility will be the number of tested patients divided by the number of patients who should have been tested according to the national guidelines (for each virus).

NCT ID: NCT04059198 Terminated - Hepatitis B Clinical Trials

Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic Treatment Naive Subjects Infected With Hepatitis B Virus

Start date: October 10, 2019
Phase: Phase 2
Study type: Interventional

An open-label, Phase 2, exploratory study to examine the safety and efficacy of inarigivir in non-cirrhotic, hepatitis B treatment-naive subjects with chronic HBV infection.

NCT ID: NCT04054037 Recruiting - HBV Clinical Trials

A Study of AARC Standards on Diagnosis and Treatment of Patients With HBV-ACLF in China (AARC China Study)

Start date: July 2, 2019
Phase:
Study type: Observational

The AARC China Study is to establish a widely recognized and harmonized standard of patients with HBV-ACLF in the Asia Pacific region.

NCT ID: NCT04034368 Not yet recruiting - HBV Clinical Trials

A Perspective Study of the Antiviral Efficacy and Safety of Switching to TAF Treatment in CHB Adults With Suboptimal Response (SOR) and Intolerant to Entecavir

Start date: August 2019
Phase: Phase 4
Study type: Interventional

This is a multicenter, single arm, open label, historical control pilot Study to the antiviral efficacy and safety of Suboptimal Responders to Entecavir Switching to TAF Treatment at week 48 (investigate the rates of complete virological response on switching to TAF in patients with Suboptimal response or ETV intolerance to standard ETV= 0.5 mg monotherapy).

NCT ID: NCT04023721 Terminated - Hepatitis B Clinical Trials

Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With HBV Virus and Receiving or Stopping Treatment With a NUC Inhibitor

Start date: June 18, 2019
Phase: Phase 2
Study type: Interventional

An open-label, Phase 2, exploratory study to examine the safety and efficacy of inarigivir in non-cirrhotic, hepatitis B e antigen (HBeAg)-negative subjects with chronic HBV infection.

NCT ID: NCT03932513 Terminated - Hepatitis B Clinical Trials

Evaluating the Effects of Inarigivir on Immune Response and Viral Markers in Chronic Hepatitis B Patients

Start date: April 11, 2019
Phase: Phase 2
Study type: Interventional

A single center, open-label, study to evaluate the intra-hepatic effect of inarigivir dose per day and three times per week on immune response and viral markers in virally suppressed patients with chronic hepatitis B infection