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Hepatitis clinical trials

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NCT ID: NCT05376124 Recruiting - Clinical trials for Hepatitis B, Chronic

Clinical Characteristics, Natural Outcome and Treatment Optimization of Refractory

Start date: January 1, 2022
Phase:
Study type: Observational

Refractory hepatitis B is to point to although standard application nucleoside (acid) analogue treatment undertakes primary treatment and two strengthen treatment, but existence is persistent viremia. Currently, there is no consensus on salvage therapy for patients who remain virus-positive after a second round of antiviral therapy. This is the first multicenter, prospective, parallel controlled, open-label cohort study to compare the efficacy and safety of TDF/TAF combined with ETV1.0mg regimen versus continuation of the original regimen in the treatment of refractory hepatitis B.

NCT ID: NCT05372874 Not yet recruiting - Hepatitis C Clinical Trials

Treatment of Hepatitis c by Using Direct-acting Antiviral

Start date: May 6, 2022
Phase:
Study type: Observational

Patients with hepatitis c showed increased level of oxidative stress. Increased level of serum lipid peroxidation leads to the production of toxic mediators as malondialdehyde (MDA) which lead to disease progression. Chronic stress shunt tryptophan which is essential amino acid toward kynurenic pathway leading to lower level of serotonin and melatonin level. Currently, direct-acting antivirals (DAAs) show well-established efficacy against hepatitis C virus (HCV).

NCT ID: NCT05368974 Recruiting - Hepatitis C Clinical Trials

The Treatment in Pregnancy for Hepatitis C ("TiP-HepC") Registry

TiP-HepC
Start date: February 11, 2022
Phase:
Study type: Observational

Clinical interventions to reduce the risk of vertical transmission of hepatitis C virus (HCV) infection from mother to infant are highly limited. Direct-acting antiviral (DAA) medications have demonstrated excellent safety and efficacy in non-pregnant individuals, but there is a lack of data regarding the safety of these medications in pregnant women and the effectiveness of these medications in reducing mother-to-child transmission. Therefore, although HCV screening during pregnancy is now recommended in many countries, there is no approved treatment for HCV during pregnancy. An observational study is here proposed to assess outcomes of mother-infant pairs exposed to DAAs during pregnancy within a global clinical case registry. Data regarding the exposures and outcomes of mother-infant pairs exposed to DAAs during pregnancy will be solicited and collected from clinical providers, healthcare facilities, HCV treatment programs, and other clinical practices worldwide. Data will be shared and maintained within a secure database, and cumulative data will be analyzed at pre-determined six-month intervals. The primary outcome will be the number and proportion of mother-infant pairs with adverse pregnancy or birth outcomes. The results of this study will inform HCV treatment decisions by clinical providers and programs worldwide.

NCT ID: NCT05361603 Recruiting - Hepatitis C Clinical Trials

Acceptability of Simultaneous Screening for Viral Hepatitis B, C and HIV Among Drug Users in Non-conventional Structures

SCANVIR
Start date: May 24, 2017
Phase:
Study type: Observational

The principle is to propose dedicated monthly screening days bringing together the health personnel involved (hepatologist, addictologist, nurse in charge of the program, addictology nurse and social worker) and to propose appropriate management for each situation assessed.

NCT ID: NCT05357235 Recruiting - Chronic Hepatitis B Clinical Trials

The Study on Optimal Treatment and Clinical Outcome of Chronic Hepatitis B Patients With Inactive Hypoviremia

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of HCC, which brings huge economic burden and life threat to our people. 84% - 92% of HCC in China is related to chronic HBV infection. How to further reduce the risk of liver cancer is an urgent problem to be solved in clinical research and an important direction. Although NAs treatment can make patients achieve the negative transformation of virus, it can not effectively reduce the level of virus antigen, and it also lacks the ability to improve the immune clearance of virus. As a result, the incidence of liver cancer in patients with long-term NA treatment is still 4.5% - 10.5%, and the incidence of HCC in patients with hypoviremia in Na treatment is higher. In current clinical practice, nearly 1 / 3 of patients treated with NAs can not reach the detection line of highly sensitive reagent. It is an important measure to make the patients with hypoviremia and inactive low virus replication treated by NAs below the detection line of highly sensitive reagent and further reduce the risk of HCC. However, it is still not enough to minimize the risk of HCC to achieve a complete viral response only through NA treatment. The long-term follow-up showed that the incidence of HBsAg disappeared by only 2.0% - 0.0% regardless of the long-term treatment of HBsAg. Therefore, the most important measure to minimize the occurrence of HCC is to optimize the treatment of NA treated patients with low virus replication and inactive patients with low virus replication to achieve complete virus response and clinical cure. The purpose of this study is to explore the optimal treatment scheme for chronic hepatitis B NA treated patients with hypoviremia and natural low virus replication patients to significantly reduce the risk of HCC.

NCT ID: NCT05357183 Recruiting - Chronic Hepatitis B Clinical Trials

The Study on Clinical Outcome and Treatment Optimization of Chronic Hepatitis B Patients With Hypoviremia

Start date: January 1, 2022
Phase:
Study type: Observational [Patient Registry]

Chronic hepatitis B seriously endangers the health of our people, especially the occurrence of HCC, which brings huge economic burden and life threat to our people. 84% - 92% of HCC in China is related to chronic HBV infection. How to further reduce the risk of liver cancer is an urgent problem to be solved in clinical research and an important direction. Although NAs treatment can make patients achieve the negative transformation of virus, it can not effectively reduce the level of virus antigen, and it also lacks the ability to improve the immune clearance of virus. As a result, the incidence of liver cancer in patients with long-term NA treatment is still 4.5% - 10.5%, and the incidence of HCC in patients with hypoviremia in Na treatment is higher. In current clinical practice, nearly 1 / 3 of patients treated with NAs can not reach the detection line of highly sensitive reagent. It is an important measure to make the patients with hypoviremia and inactive low virus replication treated by NAs below the detection line of highly sensitive reagent and further reduce the risk of HCC. However, it is still not enough to minimize the risk of HCC to achieve a complete viral response only through NA treatment. The long-term follow-up showed that the incidence of HBsAg disappeared by only 2.0% - 0.0% regardless of the long-term treatment of HBsAg. Therefore, the most important measure to minimize the occurrence of HCC is to optimize the treatment of NA treated patients with low virus replication and inactive patients with low virus replication to achieve complete virus response and clinical cure. The purpose of this study is to explore the optimal treatment scheme for chronic hepatitis B NA treated patients with hypoviremia and natural low virus replication patients to significantly reduce the risk of HCC.

NCT ID: NCT05355467 Completed - Clinical trials for Chronic Hepatitis B Infection

Efficacy and Safety of Ricovir® in Maintaining Durability of Viral Response in Chronic Hepatitis B Patients Who Have Been Treated With Viread® and Have Undetectable HBV DNA in Serum

Start date: August 21, 2019
Phase: Phase 4
Study type: Interventional

This is a phase IV, open label, historical controlled comparative study to evaluate the efficacy and safety of Ricovir® in maintaining durability of viral response in CHB patients who have been treated with Viread® and have undetectable HBV DNA in serum by real-time polymerase chain reaction (PCR) assay.

NCT ID: NCT05345990 Recruiting - Chronic Hepatitis B Clinical Trials

Treatment of Patients With Chronic Hepatitis B With Hepatitis B Immunoglobulins

HBIG
Start date: August 15, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label, single arm (two cohorts), single-center, phase II pilot-study to provide preliminary evidence whether hepatitis B immunoglobulins (HBIG) are efficacious and can be safely used in patients with chronic Hepatitis B Virus (HBV) infection. A total of 20 patients (male or female adults aged ≥ 18 years) will be enrolled in the study and receive hepatitis B immunoglobulins Hepatect®CP and Zutectra®.

NCT ID: NCT05345847 Not yet recruiting - Hepatitis Immune Clinical Trials

Steroid Sparing in Immune Related Hepatitis (irH)

Start date: December 30, 2024
Phase: N/A
Study type: Interventional

A multi-centre, randomized, non-inferiority trial in patients with irH, randomized to receive either close surveillance with corticosteroid rescue therapy or early high dose corticosteroids.

NCT ID: NCT05343481 Recruiting - Chronic Hepatitis B Clinical Trials

Efficacy of VTP-300 in Chronic Hepatitis B Infection

Start date: September 21, 2022
Phase: Phase 2
Study type: Interventional

This is an open-label study to determine the efficacy, safety, tolerability and immunogenicity of ChAdOx1-HBV and MVA-HBV, together VTP-300, in combination with low-dose nivolumab, in patients with chronic HBV who are virally suppressed with oral anti-viral therapies.