Clinical trials: Chronic Hepatitis b
Chronic Hepatitis B
Truvada Versus Truvada Plus Hepatitis B Immunoglobulin (HBIg) in Prevention of Chronic Hepatitis B Recurrence Post Liver Transplant
The objective of this 96-week study was to evaluate the safety and antiviral efficacy of emtricitabine/tenofovir disoproxil fumarate (FTC/TDF, coformulated; Truvada®) with or without hepatitis B immunoglobulin (HBIg) in…
- Trial name
- NCT00507689
- Testing
- FTC/TDF, Hepatitis B Immunoglobulin (HBIg)
- Where
- 7 sites in United States
- Volunteers
- 40 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) From Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV)
The primary objective of this study is to evaluate the safety and tolerability and virologic response of tenofovir alafenamide (TAF) in virologically suppressed chronic hepatitis B participants with renal and/or hepatic…
- Trial name
- NCT03180619
- Testing
- TAF
- Where
- 30 sites in United States, Canada and 6 more
- Volunteers
- 124 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
A Study Evaluating Treatment Intensification With ABI-H0731 in Participants With Chronic Hepatitis B Infection on Nucleos(t)Ide Reverse Transcriptase Inhibitors
This study will explore the safety and antiviral activity of ABI-H0731 when added to a nucleos(t)ide reverse transcriptase inhibitor (NrtI) in participants who are partially virologically suppressed.
- Trial name
- NCT04454567
- Testing
- ABI-H0731, NrtI
- Where
- 12 sites in United States, Hong Kong and 1 more
- Volunteers
- 2 people
- Sponsor
- Assembly Biosciences
Hepatitis B, Chronic
Tenofovir Disoproxil Fumarate (TDF) 300mg 3 Years RD Therapy Chinese Chronic Hepatitis B (CHN) CHB Multiple Nucleos(t)Ide Analogues (NAs) Failure Points Pts PH4 PMS Study
This is a phase IV, single-arm, open-label, multi-centre study to assess the efficacy of TDF in Chronic hepatitis B (CHB) subjects following failure of multiple Nucleos(t)ide analogues (NAs).
- Trial name
- NCT02195518
- Testing
- Tenofovir disoproxil fumarate
- Where
- 12 sites in China
- Volunteers
- 213 people
- Sponsor
- GlaxoSmithKline
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
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 to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Doses of RO7049389 in Healthy Volunteers and Chronic Hepatitis B Virus (HBV) Infected Participants
This study is a multicenter, three-part study. Parts 1 and 2 are randomized, investigator- and participant-blinded, placebo-control, single-ascending dose (SAD) and multiple-ascending dose (MAD) study to evaluate the safety…
- Trial name
- NCT02952924
- Testing
- Midazolam, RO7049389
- Where
- 21 sites in Australia, Bulgaria and 6 more
- Volunteers
- 192 people, healthy volunteers welcome
- Sponsor
- Hoffmann-La Roche
Hepatitis B
Comparison of Entecavir to Adefovir in Chronic Hepatitis B Virus (HBV) Patients With Hepatic Decompensation
This is a phase IIIb comparative study of entecavir 1.0 mg once daily (QD) vs. adefovir 10 mg QD in patients who have chronic hepatitis B infection and hepatic decompensation.
- Trial name
- NCT00065507
- Testing
- Entecavir (ETV), Adefovir (ADV)
- Where
- 61 sites in United States, Brazil and 15 more
- Volunteers
- 195 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
Study to Evaluate the Safety, Tolerability, and Antiviral Activity of Selgantolimod (Formerly GS-9688) in Viremic Adult Participants With Chronic Hepatitis B (CHB) Who Are Not Currently on Treatment
The primary objectives of this study are to evaluate the safety and tolerability of multiple oral doses of selgantolimod and to evaluate the antiviral activity of selgantolimod in adult participants with chronic hepatitis B (CHB)…
- Trial name
- NCT03615066
- Testing
- Selgantolimod, TAF
- Where
- 10 sites in Canada, South Korea and 1 more
- Volunteers
- 67 people
- Sponsor
- Gilead Sciences
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, Healthy
First in Human Study of ChAdOx1-HBV in Healthy Participants and Participants With Chronic hepB Infection
This is a Phase 1, first in human study of ChAdOx1-HBV. The study will be conducted in 40 healthy participants and 12 participants with CHB and virally suppressed with oral antiviral medication.
- Trial name
- NCT04297917
- Testing
- ChAdOx1-HBV
- Where
- 4 sites in United Kingdom
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Barinthus Biotherapeutics
Hepatitis B Infection
Effect of Entecavir in Blacks/African Americans and Hispanics With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this clinical research study is to develop observational clinical experience with the use of entecavir in participants who are either of Black/African-American race or of Hispanic ethnicity.
- Trial name
- NCT00371150
- Testing
- Entecavir
- Where
- 27 sites in United States, Brazil and 3 more
- Volunteers
- 131 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B
An Efficacy, Safety, and Pharmacokinetics Study of JNJ-56136379 in Participants With Chronic Hepatitis B Virus Infection
The main purpose of this study is to evaluate efficacy of 24 weeks of study treatment, in terms of changes in hepatitis B surface antigen (HBsAg) levels.
- Trial name
- NCT03361956
- Testing
- JNJ-56136379, NA (ETV or TDF)
- Where
- 76 sites in United States, Belgium and 17 more
- Volunteers
- 232 people
- Sponsor
- Janssen Sciences Ireland UC
Hepatitis B, Chronic Hepatitis B Atypical
Safety, Tolerability, Pharmacokinetics and Antiviral Activity of IONIS-HBVRx in Treatment-Naïve Patients With Chronic HBV Infection
To examine the safety and tolerability of IONIS-HBVRx administration to treatment-naive patients with chronic hepatitis B virus infection
- Trial name
- NCT02981602
- Testing
- IONIS-HBVRx
- Where
- 7 sites in Hong Kong, South Korea
- Volunteers
- 31 people
- Sponsor
- GlaxoSmithKline
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
Hepatitis B, Chronic
HepTcell Immunotherapy in Patients With Inactive Chronic Hepatitis B (CHB)
A study to evaluate the antiviral effects, immunogenicity, and safety of HepTcell in treatment-naive patients with inactive chronic hepatitis B (CHB) and low hepatitis B surface antigen (HBsAg) levels.
- Trial name
- NCT04684914
- Testing
- HepTcell
- Where
- 21 sites in United States, Canada and 3 more
- Volunteers
- 87 people
- Sponsor
- Altimmune, Inc.
Hepatitis B
Study of Combination Therapy With LdT Plus Adefovir Versus Adefovir Alone
This study is being conducted to compare the safety and effectiveness of the investigational medication LdT (telbivudine) used in combination with adefovir dipivoxil (a drug currently approved by the Food and Drug Administration…
- Trial name
- NCT00376259
- Testing
- telbivudine, adefovir dipivoxil
- Where
- 6 sites in United States, Hong Kong and 3 more
- Volunteers
- 43 people
- Sponsor
- Novartis
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
Hepatitis B
A Study to Assess the Safety, Tolerability, Pharmacokinetics (PK) and Pharmacodynamics (PD) of GSK3389404 in Chronic Hepatitis B (CHB) Subjects
GSK3389404 is being developed for the treatment of CHB virus infection. The development goal for GSK3389404 is the establishment of a finite duration treatment that results in sustained suppression of hepatitis B virus (HBV)…
- Trial name
- NCT03020745
- Testing
- GSK3389404
- Where
- 21 sites in China, Hong Kong and 4 more
- Volunteers
- 78 people
- Sponsor
- GlaxoSmithKline
Immunologic Tests
A Study in Adult Subjects With Chronic Hepatitis B Infection to Support the Development of Immunological Assays
The purpose of this study is to develop and characterize immunological assays on blood samples.
- Trial name
- NCT01098006
- Testing
- Blood withdrawal
- Where
- 2 sites in Belgium
- Volunteers
- 99 people
- Sponsor
- GlaxoSmithKline