Clinical trials: Chronic Hepatitis B Infections
Chronic Hepatitis b
Treatment Efficacy and Safety of TDF-TAF Switch Study in South Korea
Recent TAF has introduced to have more safe profiles than TDF in clinical trials. Especially, TDF has the renal safety issue in high risk group including HIV, decompensated cirrhosis (ascites), uncontrolled DM etc.
- Trial name
- NCT03559790
- Testing
- tenofovir alafenamide
- Where
- South Korea
- Volunteers
- 400 people
- Sponsor
- The Catholic University of Korea
Chronic Hepatitis b
A Post-marketing Surveillance to Assess Safety and Efficacy of Besivo
This study is a post-marketing surveillance of Besivo in participants with chronic hepatitis B.
- Trial name
- NCT03642340
- Where
- South Korea
- Volunteers
- 3,000 people
- Sponsor
- IlDong Pharmaceutical Co Ltd
End Stage Renal Disease
Safety and Immunogenicity of HEPLISAV™ a Hepatitis B Virus Vaccine in Adults on Hemodialysis
The purpose of this study is to compare the immune response to HEPLISAV™ booster injection with the immune response to Engerix-B® and Fendrix® booster vaccinations among patients with end stage renal disease (ESRD) on…
- Trial name
- NCT01195246
- Testing
- HEPLISAV, Engerix-B, Fendrix
- Where
- 19 sites in Germany
- Volunteers
- 155 people
- Sponsor
- Dynavax Technologies Corporation
Chronic Hepatitis B
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics and Pharmacodynamics of RO7062931in Healthy Volunteers and Subjects With Chronic Hepatitis B
This randomized study will be conducted in two parts to evaluate the safety, tolerability, pharmacodynamics, and pharmacokinetics of subcutaneous administration of RO7062931.
- Trial name
- NCT03038113
- Testing
- RO7062931, Immune Modulator
- Where
- 19 sites in Australia, Hong Kong and 5 more
- Volunteers
- 119 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
ADVANCE Study: A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) + Adefovir Dipivoxil in Patients With Hbe(-) Chronic Hepatitis B
This 3 arm study will compare the efficacy and safety of combination therapy with PEGASYS + adefovir dipivoxil (ADV) versus PEGASYS monotherapy, in HBeAg-negative chronic hepatitis B patients.Patients will be randomized to…
- Trial name
- NCT00661076
- Testing
- adefovir dipivoxil, peginterferon alfa-2a [Pegasys]
- Where
- 5 sites in Turkey (Türkiye)
- Volunteers
- 10 people
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Clinical Study to Evaluate the Safety, Tolerance and Pharmacokinetic Characteristics of Single Administration of HRS-5635 Injection in Chinese Healthy Subjects and the Safety, Tolerance, Pharmacokinetics and Antiviral Effect of Multiple Administration in Patients With Chronic Hepatitis B
The study is being conducted to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of HRS-5635 in healthy adults and chronic hepatitis B. To explore the reasonable dosage of HRS-5635.
- Trial name
- NCT05808374
- Testing
- HRS-5635
- Where
- China
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Fujian Shengdi Pharmaceutical Co., Ltd.
Chronic Hepatitis B
Randomized Controlled Study of Tenofovir Plus Telbivudine Versus Monotherapy With Either Drug in HBeAg Negative Chronic Hepatitis B Patients
Combination therapies using nucleos(t)ide analogues lead to higher viral suppression although it may not be sustained for long. Also it remains unknown if combination of more potent analogues is more beneficial than individual…
- Trial name
- NCT01260610
- Testing
- Tenofovir, Telbivudine, Tenofovir plus Telbivudine
- Where
- India
- Sponsor
- Institute of Liver and Biliary Sciences, India
Hepatitis B, Chronic
Efficacy and Safety of DA-2802 in Chronic Hepatitis B Patients
A study demonstrates the non-inferiority of DA-2802 when compared with ㅍViread® in chronic hepatitis B patients
- Trial name
- NCT02967939
- Testing
- DA-2802, Viread®
- Where
- South Korea
- Volunteers
- 123 people
- Sponsor
- Dong-A ST Co., Ltd.
Chronic Hepatitis B
Safety and Antiviral Study of ACH126, 433 (b-L-Fd4C) in Adults With Lamivudine-resistant Chronic Hepatitis B
The purpose of this study was to determine the safety and antiviral hepatitis B virus (HBV) activity of ACH126, 433 in the treatment of adults with lamivudine-resistant chronic hepatitis B.
- Trial name
- NCT00040144
- Testing
- ACH126, 433
- Where
- 18 sites in United States, Canada and 1 more
- Volunteers
- 85 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatitis B, Carcinoma, Hepatocellular
Effect of Polymorphisms in the IL-1 Gene Complex on the Development of Chronic Hepatitis and Hepatocellular Carcinoma
The purpose of this study is to determine the effect of polymorphisms in the IL-1 gene complex on the development of chronic hepatitis and hepatocellular carcinoma.
- Conditions
- Hepatitis B, Carcinoma, Hepatocellular, Polymorphism, Genetic
- Trial name
- NCT00155103
- Where
- Taiwan
- Volunteers
- 1,600 people, healthy volunteers welcome
- Sponsor
- National Taiwan University Hospital
Chronic Hepatitis b
A Study to Investigate the Safety, Efficacy and PK of Multiple Doses of QL-007 in Chronic Hepatitis B Patients in CHINA
This is a randomized, open-label, positive-control, dose-escalation Phase 1b trial in 60 patients with chronic HBV infection to determine the safety, preliminary efficacy, and pharmacokinetics (PK) of QL-007 after administration…
- Trial name
- QL-007 (NCT03770624)
- Testing
- QL-007 tablet, TDF
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Qilu Pharmaceutical Co., Ltd.
Chronic Hepatitis B, Hepatocellular Carcinoma
Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is one of the most common solid cancers worldwide, and chronic hepatitis B virus (HBV) infection is the most common etiology of HCC in Asia.
- Trial name
- NCT01872988
- Testing
- Tenofovir
- Where
- 4 sites in Taiwan
- Volunteers
- 320 people
- Sponsor
- Taichung Veterans General Hospital
Liver Fibrosis
A Nomogram for Evaluating Significant Liver Fibrosis in Patients With Chronic Hepatitis B Virus Infection
Liver fibrosis is the key step for progression to cirrhosis and liver cancer in patients with chronic hepatitis B (CHB). It is crucial to identify significant liver fibrosis in the treatment of CHB patients.
- Trial name
- NCT05560503
- Volunteers
- 259 people
- Sponsor
- Xiangya Hospital of Central South University
Chronic Hepatitis B
Stopping TDF Treatment After Long Term Virologic Suppression in HBeAg-negative CHB
The primary objective of this study is to evaluate hepatitis B surface antigen (HBsAg) loss and seroconversion in participants who stop tenofovir disoproxil fumarate (TDF) (Stop TDF arm) compared to participants who continue TDF…
- Trial name
- FINITE CHB (NCT01320943)
- Testing
- TDF, Stop TDF
- Where
- 13 sites in Germany
- Volunteers
- 43 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic, Mother to Child Transmission
Preventing Mother-to-child Transmission of Hepatitis B Virus With Tenofovir Alafenamide (TAF)
The purpose of this study is to evaluate the efficacy and safety of Tenofovir alafenamide (TAF) for prevention of mother-to-child transmission of hepatitis B virus among pregnant women with high level HBV DNA.
- Trial name
- NCT05177926
- Testing
- antiviral prophylaxis with Tenofovir Alafenamide Fumarate
- Where
- 13 sites in China
- Volunteers
- 330 people
- Sponsor
- Nanfang Hospital, Southern Medical University
Chronic Hepatitis b, Anti-PD-1 Antibody
A Novel Combination Therapeutic Strategy Aiming to Functional Cure for Chronic Hepatitis B Virus Infection (Sustained HBsAg Loss) (A)
Hepatitis B virus (HBV) infection is a major public health threat in China. At present, a functional cure, also known as clinical cure or sustained Hepatitis B surface antigen (HBsAg) loss, is recommended as the ideal endpoint of…
- Trial name
- NCT05769816
- Testing
- Anti-PD-1 antibody, NAs
- Where
- China
- Volunteers
- 120 people
- Sponsor
- The Second Affiliated Hospital of Chongqing Medical University
Chronic Hepatitis b
TAF Real World Study for Universal Effectiveness
This study is a multi-center, prospective, real-world study, males and non-pregnant, non-lactating female HBeAg positive or negative patients (above 18 years of age) who were mono-infected with HBV, either NA treatment-naïve or…
- Trial name
- TRUE (NCT03752658)
- Testing
- Tenofovir Alafenamide
- Where
- 7 sites in China
- Volunteers
- 500 people
- Sponsor
- Tongji Hospital
Chronic Hepatitis B
Pegylated Interferon(Peg-IFN) in Reducing Relapse Rate in Patients After Discontinuation of NUC Therapy
This study evaluates whether Peg-IFN alfa-2a can reduce the recurrence rate of hepatitis B in 96 weeks after nucleoside analogue (NUC) withdrawal.
- Trial name
- NCT02594293
- Testing
- PegIFN alfa-2a
- Where
- 19 sites in China
- Volunteers
- 180 people
- Sponsor
- Huashan Hospital
Liver Fibrosis, HEPATITIS B CHRONIC
A Study to Evaluate a Study Drug, DCB-BO1202, for Alleviating Liver Fibrosis in Liver Cancer Patients
The purpose of this study is to determine whether an investigational drug DCB-BO1202 is effective and safe in the treatment of liver fibrosis in HBV patients having experienced intermediate stage hepatocellular carcinoma (HCC)
- Conditions
- Liver Fibrosis, HEPATITIS B CHRONIC, Hepatocellular Carcinoma
- Trial name
- NCT02289300
- Testing
- DCB-BO1202
- Where
- Taiwan
- Sponsor
- A2 Healthcare Taiwan Corporation
Hepatitis B, HIV Infection
Adefovir Dipivoxil to Treat Hepatitis B in HIV-Infected Patients
This study will evaluate the safety and effectiveness of adding the experimental drug adefovir dipivoxil to lamivudine for treating hepatitis B virus (HBV) infection in HIV-infected patients with liver cirrhosis.
- Trial name
- NCT00013702
- Testing
- Adefovir
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
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