Clinical trials: HEPATITIS B CHRONIC
Chronic Hepatitis B
Adefovir Dipivoxil Tablets (10mg) In Chinese Subjects With HBe Antigen Negative Chronic Hepatitis B
This is a phase IV, 2-year, multi-center, single arm and open-label study, evaluating the efficacy and safety with using local manufactured adefovir dipivoxil in Chinese subjects with HBeAg negative chronic hepatitis B
- Trial name
- NCT00324961
- Testing
- adefovir dipivoxil tablets
- Where
- 18 sites in China
- Volunteers
- 533 people
- Sponsor
- GlaxoSmithKline
Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease
Sonoelastography: Ultrasound Method to Measure Liver Fibrosis
HYPOTHESIS: The investigators hypothesize that sonoelastography (SE) will provide accurate quantitative measurements that can be used to stage liver fibrosis in patients with chronic liver disease. 1.
- Conditions
- Chronic Liver Disease, Non-Alcoholic Fatty Liver Disease, Hepatitis C Virus (HCV) Coinfection, Hepatitis B Virus (HBV)
- Trial name
- NCT01747772
- Testing
- Shear Wave Sonoelastography
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- Massachusetts General Hospital
Hepatitis B, Chronic
Phase 3 Study of GSK548470 in Patients With Compensated Chronic Hepatitis B Untreated With Nucleic Acid Analogue
The purpose of this study is to evaluate the efficacy and safety of GSK548470 administered once daily at a dose level of 300 mg to Japanese patients with compensated chronic hepatitis B untreated with any nucleic acid analogue.
- Trial name
- NCT01480284
- Testing
- GSK548470 300 mg tablet, ETV 0.5 mg capsule
- Where
- 32 sites in Japan
- Volunteers
- 166 people
- Sponsor
- GlaxoSmithKline
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Combination With Adefovir or Entecavir in Patients With HBeAg-Positive Chronic Hepatitis B
This 3 arm study will assess the efficacy and safety of PEGASYS alone, or in combination with Adefovir or Entecavir in patients with HBeAg positive chronic hepatitis B.
- Trial name
- NCT00922207
- Testing
- Adefovir, Entecavir, peginterferon alfa-2a [Pegasys]
- Where
- 9 sites in Taiwan
- Volunteers
- 280 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B, Chronic
Entecavir Plus Adefovir in Lamivudine-Resistant Chronic Hepatitis B Patients Who Fail Lamivudine Plus Adefovir
The presence of persistent inadequate or suboptimal virologic response is a strong risk factor for viral resistance and breakthrough and also for disease progression of chronic hepatitis B, and thus, a change in therapy is…
- Trial name
- CAESAR (NCT01023217)
- Testing
- Adefovir, Entecavir, Lamivudine
- Where
- South Korea
- Volunteers
- 90 people
- Sponsor
- Asan Medical Center
Hepatitis B, Hepatitis D
Study of ARC-520 With or Without Other Drugs Used in the Treatment of Chronic Chronic Hepatitis B Virus (HBV)
Patients with chronic HBV infection will receive either ARC-520 alone or ARC-520 in combination with other treatments such as entecavir (ENT) or tenofovir (TDF) and/or pegylated interferon (PEG IFN) alpha 2a therapy, and be…
- Trial name
- MONARCH (NCT02577029)
- Testing
- ARC-520, entecavir, pegylated interferon alpha 2a
- Where
- 33 sites in Australia, Bulgaria and 6 more
- Volunteers
- 79 people
- Sponsor
- Arrowhead Pharmaceuticals
Cirrhosis, End Stage Liver Disease
Mild Hypothermia and Acute Kidney Injury in Liver Transplantation
Acute kidney injury (AKI), or worsening kidney function, is a common complication after liver transplantation (20-90% in published studies).
- Conditions
- Cirrhosis, End Stage Liver Disease, Acute Kidney Injury, Liver Transplant; Complications
- Trial name
- MHALT (NCT03534141)
- Testing
- Esophageal cooling/warming device, Mild hypothermia, Normothermia
- Where
- 3 sites in United States
- Volunteers
- 175 people
- Sponsor
- University of California, San Francisco
Hepatitis B, Chronic
A Study of Different Combination Regimens Including JNJ-73763989 and/or JNJ-56136379 for the Treatment of Chronic Hepatitis B Virus Infection
The purpose of this study is to establish the dose-response relationship for antiviral activity of 3 dose levels of JNJ-73763989+nucleos(t)ide analog (NA) and to evaluate the efficacy of combination regimens of JNJ-73763989+NA…
- Trial name
- REEF-1 (NCT03982186)
- Testing
- JNJ-73763989, JNJ-56136379, Nucleos(t)ide Analog (NA)
- Where
- 108 sites in United States, Belgium and 17 more
- Volunteers
- 471 people
- Sponsor
- Janssen Sciences Ireland UC
Chronic Hepatitis B
Study to Evaluate the Safety and Antiviral Activity of Inarigivir Soproxil (Formerly: GS-9992) Plus Tenofovir Alafenamide (TAF) for 12 Weeks in Adults With Chronic Hepatitis B (CHB)
The primary objectives of this study are to evaluate the safety and tolerability of the 12 week treatment regimens of inarigivir soproxil plus tenofovir alafenamide (TAF) or commercially available nucleoside/nucleotide (NUC) in…
- Trial name
- NCT03434353
- Testing
- Inarigivir Soproxil, TAF
- Where
- 13 sites in Hong Kong, South Korea
- Volunteers
- 123 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
Treatment Outcomes in Chronic Hepatitis B Patients on Sequential Therapy With Tenofovir Alafenamide (TAF)
Primary Objective: To describe rate of persistence and/or improvement of viral suppression with TAF as with previous anti-HBV (hepatitis B virus) treatment
- Trial name
- NCT03471624
- Testing
- Tenofovir Alafenamide
- Where
- 12 sites in United States, Japan and 2 more
- Volunteers
- 270 people
- Sponsor
- Stanford University
Hepatitis B, Chronic
An Expanded Access Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Negative Chronic Hepatitis B
This is an expanded access programme to make Pegasys (peginterferon alfa-2a) available to patients with HBeAg-negative chronic hepatitis B in Morocco.
- Trial name
- NCT01787279
- Testing
- Peginterferon alfa-2a [Pegasys]
- Where
- 4 sites in Morocco
- Volunteers
- 59 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B Virus Infection
A Study of RO7239958 to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics in Healthy Volunteers and Participants With Chronic Hepatitis B Virus Infection
This study is designed to assess the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single and multiple ascending doses in healthy volunteers (HV) and participants diagnosed with chronic hepatitis B…
- Trial name
- NCT03762681
- Testing
- RO7239958
- Where
- 14 sites in Bulgaria, Hong Kong and 5 more
- Volunteers
- 55 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Treatment of Persistent Viremia (Virus in Blood) in Chronic Hepatitis B Subjects Already Receiving Adefovir Dipivoxil
This study explores the efficacy, safety and tolerability of tenofovir DF (TDF) 300 mg once daily monotherapy versus the combination of emtricitabine 200 mg plus tenofovir DF 300 mg (FTC/TDF) once daily in subjects currently…
- Trial name
- NCT00307489
- Testing
- tenofovir DF, emtricitabine /tenofovir DF
- Where
- 28 sites in United States, France and 2 more
- Volunteers
- 106 people
- Sponsor
- Gilead Sciences
Hepatitis B
A Study to Assess Intrahepatic and Peripheral Changes of Immunologic and Virologic Markers in Chronic Hepatitis B Virus Infection
The purpose of this study is to assess changes in intrahepatic hepatitis B surface antigen (HBsAg) between baseline and on-treatment liver biopsy in response to JNJ-3989-based combination treatment.
- Trial name
- INSIGHT (NCT04585789)
- Testing
- JNJ-73763989, JNJ-56136379, Entecavir (ETV)
- Where
- 10 sites in United States, Belgium and 7 more
- Volunteers
- 24 people
- Sponsor
- Janssen Research & Development, LLC
Hepatitis B, Chronic
Combination Treatment With REP 2139-Ca and Pegasys in Patients With Chronic Hepatitis B
The REP 201 protocol is a small exploratory study assessing the antiviral effects and tolerability of REP 2139-Ca when used with a full course of pegylated interferon (48 weeks) in treatment naive patients or in patients already…
- Trial name
- NCT02726789
- Testing
- REP 2139-Ca, pegylated interferon, entecavir
- Volunteers
- 5 people
- Sponsor
- Replicor Inc.
Chronic Hepatitis B
Study of Efficacy and Safety, Tolerability and Pharmacokinetics of Telbivudine in Children and Adolescents With Compensated Chronic Hepatitis B Virus Infection
The purpose of the study was to assess the efficacy and safety of telbivudine at a dose of 20 mg/kg up to a maximum of 600 mg q.d.
- Trial name
- NCT02058108
- Testing
- Telbivudine
- Where
- 29 sites in Bulgaria, Greece and 5 more
- Volunteers
- 53 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Hepatitis B
Rollover Protocol Continued Access to Emtricitabine/Tenofovir Disoproxil Fumarate for Adults in United States
The objective of this study is to provide open label emtricitabine/tenofovir disoproxil fumarate (FTC/TDF) for an additional 5 years (240 weeks) to adults completing study GS-US-203-0107.
- Trial name
- NCT00936715
- Testing
- FTC/TDF
- Where
- 4 sites in United States
- Volunteers
- 24 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
A Study in Korea of Entecavir Versus Lamivudine in Adults With Chronic Hepatitis B Infection
Entecavir, 0.5 mg daily, will have clinical efficacy (assessed as an undetectable hepatitis B DNA, <300 copies/mL, by Roche Comprehensive Bio-Analytical System Amplicor polymerase chain reaction assay) that is comparable…
- Trial name
- NCT00393484
- Testing
- Entecavir, Lamivudine
- Where
- 15 sites in South Korea
- Volunteers
- 122 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies
This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.
- Trial name
- NCT00142298
- Testing
- Telbivudine (LdT)
- Where
- 39 sites in United States, Australia and 19 more
- Volunteers
- 1,869 people
- Sponsor
- Novartis Pharmaceuticals
Chronic Hepatitis B
Hepatitis B Vaccine in Chronic Hepatitis B Patients With Low Serum HBsAg
Background: The HBsAg clearance rate in interferon-treated responders is significantly higher than that in lamivudine-treated responders, implying immune control is the key to HBsAg clearance.
- Trial name
- NCT01817725
- Testing
- HBV vaccine (Engerix B)
- Where
- Taiwan
- Volunteers
- 20 people
- Sponsor
- Chang Gung Memorial Hospital