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Hepatitis clinical trials

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NCT ID: NCT04251572 Recruiting - Drug Use Clinical Trials

HCV Reinfection After DAA Therapy in PWID in Belgium

REINF_HCV
Start date: July 1, 2019
Phase: N/A
Study type: Interventional

The primary aim of this study is to calculate the incidence of HCV reinfection after successful DAA treatment among people who have recently injected drugs. The secondary aim is to identify factors associated with reinfection in this population. Individuals with active injecting drug abuse with a chronic HCV infection who have achieved end of treatment response (ETR; defined as non-detectable HCV RNA at end of treatment) to any interferon-free DAA combination will be included in this multicenter interventional study.

NCT ID: NCT04231565 Recruiting - Hepatitis B Virus Clinical Trials

Nucleoside (Acid) Analogues Treatment in Patients With Normal ALT and Positive HBVDNA.

ALTHBV
Start date: June 4, 2020
Phase: N/A
Study type: Interventional

This study is to investigate the clinical efficacy and safety of Nucleoside (acid) analogues treatment in patients with normal Alanine Aminotransferase and positive Hepatitis B virus DNA.

NCT ID: NCT04214028 Recruiting - Clinical trials for Hepatitis C Virus (HCV)

A Study of the Safety, Effectiveness and Clinical Use of Maviret in Adolescent Patients With Chronic Hepatitis C Virus

Start date: December 26, 2019
Phase:
Study type: Observational

This study will assess the safety and effectiveness of Maviret (Glecaprevir plus Pibrentasvir (GLE/PIB)) in adolescent participants diagnosed with chronic hepatitis C (CHC) in a real world setting across clinical practice in Japan.

NCT ID: NCT04211844 Recruiting - Chronic Hepatitis C Clinical Trials

Metabolic Changes in Chronic HCV Patients Receiving DAAS

HCV DAAS
Start date: October 1, 2019
Phase:
Study type: Observational [Patient Registry]

Observational Study to check metabolic changes between two different hepatitis C antiviral medication groups. This study will evaluate the impact of different treatments on Serum lipid changes, fasting blood glucose and glycated hemoglobin . It will determine if changes are due to different Antiviral regimens or due to different Sustained virological response rates.

NCT ID: NCT04211805 Recruiting - Pregnancy Related Clinical Trials

Maternal Therapy With TAF Versus TDF to Prevent Vertical Transmission of Hepatitis B

Start date: January 27, 2020
Phase:
Study type: Observational

Immunoprophylaxis failure of hepatitis B (HBV) remains a concern and has been reported in approximately 10-30% of infants born to highly viremic mothers with HBeAg-positive. Maternal HBV DNA >6log10 copies/mL (or 200,000 IU/mL) is the major independent risk for mother-to-child transmission (MTCT). Two recent random controlled trial (RCT) studies have shown that the use of Tenofovir Disoproxil Fumarate (TDF) in highly viremic HBsAg positive mothers may safely reduce the rate of MTCT when compared between groups of TDF treated and untreated patients. Tenofovir Alafenamide (TAF) is the successor to TDF, and both drugs have a similar mechanism of action to reduce HBV DNA levels and normalize serum alanine aminotransferase (ALT) in chronic hepatitis B patients (CHB) with few adverse effects. TAF however, has a better safety profile with less adverse effects to bone mineral density and renal function. The present prospective, double-arm study is to evaluate the non-inferiority in the efficacy and safety of TAF therapy versus TDF therapy in highly viremic mothers and their infants for the prevention of MTCT in the real world setting.

NCT ID: NCT04208035 Recruiting - Chronic Hepatitis c Clinical Trials

Hepatitis C Elimination in the Netherlands

CELINE
Start date: September 17, 2018
Phase:
Study type: Observational

The aim of CELINE is to retrieve and re-evaluate lost to follow-up chronic hepatitis C patients in the Netherlands.

NCT ID: NCT04202536 Recruiting - Hepatitis B Clinical Trials

Switching From Tenofovir Disoproxil Fumarate to Besifovir Dipivoxil Maleate

Start date: May 29, 2019
Phase: Phase 4
Study type: Interventional

A research study to observe the safety, efficacy and tolerability of switching from Tenofovir Disoproxil Fumarate to Besifovir dipivoxil maleate in patients with chronic hepatitis B

NCT ID: NCT04201808 Recruiting - Clinical trials for Hepatitis B, Chronic

Efficacy and Safety of TAF in Patients With Suboptimal Response to Other Nucleos(t)Ides

Start date: May 1, 2021
Phase: Phase 4
Study type: Interventional

Both tenofovir disoproxil fumarate (TDF) and tenofovir alafenamide (TAF) are potent antiviral agents for hepatitis B virus (HBV) and recommended by the American Association for the Study of Liver Disease (AASLD) as well as the European Association for the Study of Liver (EASL) guidelines for the treatment of nucleos(t)ide therapy induced HBV resistance. However, it is not clear if chronic hepatitis B (CHB) patients with nucleos(t)ide treatment experience without genotypic mutations would be benefit from TAF therapy. Previous studies have observed that suboptimal response (SOR) following antiviral therapy with nucleos(t)ide treatment is associated with an increased risk of subsequent treatment failure and viral resistance. It remains unclear whether switching to TAF is a reasonable approach in patients with SOR to second-line antivirals Lamivudine (LAM)/ Telbivudine (LdT)/ Adefovir Dipivoxil (ADV) and its combinations with other second-line antivirals for 24 weeks, or SOR to the first-line antiviral Entecavir (ETV) or any antiviral combinations containing ETV for 48 weeks. This study is aimed to determine how the aforementioned patients with SOR to nucleos(t)ide treatment respond to TAF monotherapy. The investigator's study will provide evidence base for therapy selection in SOR patients, especially in China where the majority of patients with CHB are treated with nucleos(t)ide therapy.

NCT ID: NCT04199819 Recruiting - Clinical trials for Liver Transplant; Complications

Detecting Occult HBV Infection in Liver Donors Positive for Antibody to Hepatitis B Core Antigen (Anti-HBc)

OBI
Start date: January 1, 2022
Phase: N/A
Study type: Interventional

After LT, long-term immunosuppressive therapy is required to prevent organ rejection. Therefore, for organs which may harbour OBI, there is a risk of reactivation which may result in liver graft failure. As a consequence, all patients who receive an anti-HBc positive graft will receive antiviral prophylaxis. Currently, all such patients will be commenced on life-long entecavir, which is highly effective in preventing reactivation.2 One major disadvantage of using such a blanket approach is that a significant proportion of anti-HBc donors may not actually have underlying occult HBV infection, and recipients of such grafts may not require lifelong antiviral therapy. Current markers such as HBsAg and HBV DNA are not sensitive enough to detect the presence of OBI. This is the first trial proposed to look at the efficacy of these novel HBV biomarkers in identifying occult HBV infection when used in combination, and to identify patients who will not need long term antiviral prophylaxis.

NCT ID: NCT04196998 Recruiting - Hepatitis B Clinical Trials

Three Types of Nucleotide/Nucleoside Analogues Therapy in Patients With Hepatitis b Virus Related Compensated Cirrhosis

Start date: January 1, 2019
Phase: N/A
Study type: Interventional

This study is to investigate the clinical efficacy and safety of three types of nucleotide/nucleoside analogues in treatment of hepatitis b virus related compensated cirrhosis.