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Hepatitis, Chronic clinical trials

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NCT ID: NCT04952207 Recruiting - Clinical trials for Hepatitis C, Chronic

Effectiveness and Safety of Direct-Acting Antiviral Agents for the Treatment of Chronic Hepatitis C

C-DIAMOND
Start date: March 6, 2019
Phase:
Study type: Observational [Patient Registry]

Clinical trials evaluating DAA have shown excellent rates of SVR and good safety profiles in patients with CHC infection. Real world data from TARGET, TRIO, IFI, DHCR, DALTON-C, as well as those cohorts from Japan, Taiwan and Korea further confirmed clinical trial findings of DAA in routine practice where populations are more complex. However, these populations are different from Chinese for different host and virus characteristics which limit the applicability of results to local practice. As DAA launched in China since 2017, the availability of INF free DAA treatment will likely lead to better treatment outcome in routine practice, but there are currently no data available to test the hypothesis. In clinical practice, the uptake of DAA regimen will depend on a combination of physician preference, patient's characteristics and drug access. This study will also identify how these three variables affect DAA regimen uptake. This study to 1) characterize pts receiving IFN free DAA regimens, 2) represent common practice in China, 3) describe outcome of various INF free DAA therapy, and 4) confirm registration study results.

NCT ID: NCT04939441 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Regression of Liver Fibrosis by Tenofovir Alafenamide (TAF)

Start date: April 20, 2021
Phase: Phase 4
Study type: Interventional

Tenofovir alafenamide (TAF) is a new prodrug of tenofovir developed to treat patients with chronic hepatitis B virus (HBV) infection. Whereas, the long-term effect of TAF to liver fibrosis is still unknown. Here, we enrolled treatment naive CHB patients with biopsy-proven significant fibrosis (METAVIR fibrosis stage ≥ F2). All enrolled subjects will be treated with TAF monotherapy for 96 weeks. After 96 weeks of therapy, the second liver biopsy will be performed to evaluate the rate of liver fibrosis regression. During this study, all subjects will be assessed for laboratory tests, imaging examination at baseline, first 12-week and every 24-week during follow-up.

NCT ID: NCT04891770 Active, not recruiting - Chronic Hepatitis B Clinical Trials

Study to Evaluate the Safety and Efficacy of Selgantolimod (SLGN)-Containing Combination Therapies for the Treatment of Chronic Hepatitis B (CHB)

Start date: August 14, 2021
Phase: Phase 2
Study type: Interventional

The primary objectives of this study are to evaluate the safety and tolerability of study treatment(s) (selgantolimod-containing combination therapies) and to evaluate the efficacy of study treatment(s) as measured by the proportion of participants who achieve functional cure, defined as hepatitis B surface antigen (HBsAg) loss and hepatitis B virus (HBV)deoxyribonucleic acid (DNA) < lower limit of quantitation (LLOQ) at Follow-up (FU) Week 24 in participants with chronic hepatitis B (CHB).

NCT ID: NCT04856085 Recruiting - Clinical trials for Hepatitis B, Chronic

Study of VIR-2218, VIR-3434, and/or PEG-IFNα in Subjects With Chronic Hepatitis B Virus Infection

MARCH
Start date: July 11, 2021
Phase: Phase 2
Study type: Interventional

This is a phase 2 study in which participants with chronic hepatitis B virus (HBV) infection will receive VIR-2218, VIR-3434 and/or PEG-IFNα and be assessed for safety, tolerability, and efficacy

NCT ID: NCT04846491 Completed - Chronic Hepatitis B Clinical Trials

A Study of Peginterferon Alfa-2b Combined With TDF in Patients With Chronic Hepatitis B

Start date: December 4, 2019
Phase: Phase 3
Study type: Interventional

Current clinical practices has shown promising prospects of the therapy strategy of interferon combined with nucleos(t)ides in patients with chronic hepatitis B, but the safety and efficacy has not been fully studied. This study is aimed to exploit the safety and efficacy of the study drug, Peginterferon alfa-2b injection, with nucleos(t)ide (NAs), tenofovir disoproxil fumarate tablets (TDF), in the patients with hepatitis B, who has previously treated with nucleos(t)ides and who are treatment naïve.

NCT ID: NCT04820686 Terminated - Chronic Hepatitis B Clinical Trials

A Study Evaluating Treatment Regimens Containing Vebicorvir (ABI-H0731) in Participants With Chronic Hepatitis B Infection

Start date: May 7, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to determine if vebicorvir (VBR, ABI-H0731) in combination with AB-729 is safe and effective in participants with chronic hepatitis B infection (cHBV) receiving a standard of care nucleos(t)ide/reverse transcriptase inhibitor (SOC NrtI).

NCT ID: NCT04781647 Terminated - Chronic Hepatitis B Clinical Trials

A Study Evaluating ABI-H0731-containing Regimens in Chinese Participants With Chronic Hepatitis B Virus Infection

Start date: February 18, 2021
Phase: Phase 2
Study type: Interventional

The purpose of this study is to evaluate the safety, antiviral activity, and pharmacokinetics of ABI-H0731 in combination with entecavir (ETV) and with ETV plus pegylated-interferon alpha (Peg-IFNα) in Chinese participants with chronic hepatitis B virus infection (cHBV)

NCT ID: NCT04779970 Recruiting - Chronic Hepatitis B Clinical Trials

COIN-B: Controlled Interruption of Nucleos(t)Ide Analogue Treatment in Chronic Hepatitis B Infections

COIN-B
Start date: July 28, 2021
Phase: N/A
Study type: Interventional

In this study we will prospectively stop NA in both Caucasian and non-Caucasian patients matched for gender and age, to validate the observed host and viral parameters for future roll-out of this treatment strategy.

NCT ID: NCT04775797 Terminated - Chronic Hepatitis Clinical Trials

Safety, Tolerability, and Pharmacokinetics of AB-836 in Healthy Subjects and Subjects With Chronic HBV Infection

Start date: June 25, 2021
Phase: Phase 1
Study type: Interventional

This three-part, Phase 1 protocol will be the first clinical study of AB-836. Parts 1 and 2a/b will be a Phase 1a SAD/MAD of AB-836 in healthy adult subjects. Part 3 will be a Phase 1b dose-ranging assessment of AB-836 in non-cirrhotic Chronic Hepatitis B (CHB) subjects.

NCT ID: NCT04759521 Completed - Chronic Hepatitis B Clinical Trials

Evaluation of Liver Fibrosis With 2D-Shear Wave Elastography

Start date: January 3, 2019
Phase:
Study type: Observational [Patient Registry]

The aims of this study are to evaluate liver fibrosis with two-dimensional (2D) shear wave elastography (SWE) technique in inactive hepatitis B surface antigen (HBsAg) carriers and patients with active chronic hepatitis B (CHB), with the help of a propagation map, compare this method with histopathological results in patients with CHB and determine the suitability of 2D-SWE for use instead of liver biopsy by evaluating fibrosis before and after treatment.