Clinical trials: Chronic Hepatitis B Infection
Chronic Hepatitis B
Study of Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this study is to prospectively assess the long-term outcomes (benefits and risks) associated with entecavir (ETV) therapy as compared to other antivirals approved for the treatment of chronic HBV infection.
- Trial name
- NCT00388674
- Testing
- entecavir, Other anti-HBV medication
- Where
- 290 sites in United States, Argentina and 22 more
- Volunteers
- 12,522 people
- Sponsor
- Bristol-Myers Squibb
Chronic Hepatitis B
Adefovir Dipivoxil For The Treatment Of Chinese Compensated Chronic Hepatitis B(CHB)Patients
This 48-week open-label study of local manufactured adefovir dipivoxil Tablet evaluates the efficacy and safety of adefovir 10mg once daily in Chinese subjects with compensated CHB.
- Trial name
- NCT00441974
- Testing
- adefovir dipivoxil
- Where
- 25 sites in China
- Volunteers
- 1,470 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
Safety and Efficacy of Adefovir Dipivoxil in Children and Adolescents With Chronic Hepatitis B
The purpose of this study is to investigate the efficacy and safety of adefovir dipivoxil for the treatment of chronic hepatitis B in children and adolescents (age 2 to less than 18 years) following 48 weeks of…
- Trial name
- NCT00095121
- Testing
- Adefovir Dipivoxil (ADV), Lamivudine
- Where
- United States
- Volunteers
- 173 people
- Sponsor
- Gilead Sciences
Lactic Acidosis
Lactic Acidosis During Entecavir(ETV)Treatment
The purpose of this study is to investigate whether entecavir treatment increases the incidence of lactic acidosis compared to another nucleoside/nucleotide reverse transcriptase inhibitors (NRTI), lamivudine, and/or no NRTI…
- Trial name
- ETV (NCT01354652)
- Testing
- entecavir, lamivudine
- Volunteers
- 5 people
- Sponsor
- Asan Medical Center
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Chronic Hepatitis B.
This single arm study will assess the efficacy and safety of PEGASYS in patients with chronic hepatitis B who are either treatment-naive, or who have failed lamivudine- or interferon-treatment in the past.
- Trial name
- NCT00487747
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 23 sites in Russia
- Volunteers
- 18 people
- Sponsor
- Hoffmann-La Roche
Hepatitis B
Combination Entecavir and Peginterferon Therapy in HBeAg-Positive Immune-Tolerant Adults With Chronic Hepatitis B
The investigators evaluated the safety and efficacy of a short lead-in course (8 weeks) of entecavir followed by combination of entecavir plus peginterferon alfa-2a for 40 weeks.
- Trial name
- HBRN (NCT01369199)
- Testing
- Entecavir and peginterferon
- Where
- 21 sites in United States, Canada
- Volunteers
- 28 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Hepatitis B, Chronic
A Multicenter Study to Determine the Depth and Duration of Hepatitis B Surface Antigen (HBsAg) Reduction After Single or Multiple Doses of ARC-520, in Combination With Entecavir in Patients With Chronic Hepatitis B Virus (HBV) Infection
The purpose of this study is to determine whether ARC-520 in combination with entecavir is effective in the treatment of patients with chronic HBV Infection.
- Trial name
- NCT02065336
- Testing
- ARC-520, entecavir, chlorpheniramine
- Where
- 2 sites in Hong Kong
- Volunteers
- 58 people
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis B
A Study of ARC-521 Injection in Normal Adult Volunteers and Patients With Chronic Hepatitis B (CHB)
Normal healthy volunteer (NHV) participants will enroll sequentially into a total of 6 escalating dose levels (6 subjects per dose level), randomized to receive a single dose of ARC-521 Injection or placebo.
- Trial name
- NCT02797522
- Testing
- ARC-521 Injection, antihistamine, acetaminophen
- Where
- New Zealand
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Arrowhead Pharmaceuticals
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, Hepatitis B, Chronic
Telbivudine Versus Lamivudine in Adults With Decompensated Chronic Hepatitis B and Evidence of Cirrhosis
This research study was conducted to compare the safety and effectiveness of the investigational medication, LdT (Telbivudine) versus Lamivudine, a drug currently approved by the US, European and Asian Health Authorities for the…
- Conditions
- Hepatitis, Hepatitis B, Chronic, Cirrhosis
- Trial name
- NCT00076336
- Testing
- Telbivudine, Lamivudine
- Where
- 28 sites in United States, Australia and 19 more
- Volunteers
- 232 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B, Chronic
Suboptimal Responders to Adefovir Switching to Entecavir
Switching to Entecavir will result in superior antiviral efficacy as compared to continuing with Adefovir in patients with a suboptimal response to Adefovir
- Trial name
- NCT00718887
- Testing
- Entecavir, Adefovir/Entecavir
- Where
- 8 sites in China
- Volunteers
- 228 people
- Sponsor
- Bristol-Myers Squibb
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Hepatitis Be Antigen (HBeAg) Positive Chronic Hepatitis B (CHB).
This 4 arm study will compare the efficacy and safety of PEGASYS given for 24 or 48 weeks, and at doses of 90 or 180 micrograms weekly, in the treatment of HBeAg positive patients with chronic hepatitis B.
- Trial name
- NCT00435825
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 55 sites in United States, Australia and 11 more
- Volunteers
- 551 people
- Sponsor
- Hoffmann-La Roche
Chronic Kidney Disease
Comparing Safety and Immunogenicity of HEPLISAV-B® to Engerix-B® in Chronic Kidney Disease (CKD) Patients
The purpose of the study is to demonstrate the safety and immunogenicity of a new investigational hepatitis B virus vaccine, HEPLISAV-B, in patients 18 to 75 years of age who have progressive loss of kidney function.
- Trial name
- NCT00985426
- Testing
- HEPLISAV-B, Engerix-B
- Where
- United States
- Volunteers
- 521 people
- Sponsor
- Dynavax Technologies Corporation
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, 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, Chronic
A Study of Pegasys (Peginterferon Alfa-2a) Versus Untreated Control in Children With HBeAg Positive Chronic Hepatitis B
This parallel group, open label study will evaluate the safety and efficacy of Pegasys (peginterferon alfa-2a) versus untreated control in children (age 3 years to <18 years at baseline) with HBeAg positive chronic hepatitis B.
- Trial name
- NCT01519960
- Testing
- peginterferon alfa-2a [Pegasys]
- Where
- 39 sites in United States, Australia and 10 more
- Volunteers
- 165 people
- Sponsor
- Hoffmann-La Roche
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 Hepatitis B
Viral Kinetics Study of Telbivudine and Entecavir in Adults With Chronic Hepatitis B
This exploratory study is designed to determine the early viral kinetic profile during treatment with telbivudine or entecavir at multiple time points over 12 weeks.
- Trial name
- NCT00412529
- Testing
- Entecavir, Telbivudine
- Where
- 8 sites in South Korea
- Volunteers
- 44 people
- Sponsor
- Novartis Pharmaceuticals
Hepatitis B
A Study of GSK3228836 in Participants With Chronic Hepatitis B (CHB)
Chronic hepatitis B virus (HBV) infection is a significant worldwide medical problem. GSK3228836 demonstrated target engagement in CHB participants who were not on treatment and in CHB participants on stable nucleos(t)ide…
- Trial name
- B-Clear (NCT04449029)
- Testing
- GSK3228836, Nucleos(t)ide therapy
- Where
- 121 sites in United States, Argentina and 20 more
- Volunteers
- 457 people
- Sponsor
- GlaxoSmithKline
Hepatitis B
A Mechanistic Study of GSK3228836 With Fine Needle Aspiration (FNA) in Participants With Chronic Hepatitis B
Hepatitis B virus (HBV) infection, especially chronic, is a significant worldwide medical problem. This is an exploratory study of the therapeutic mechanism of GSK3228836 in participants with chronic hepatitis B (CHB) on stable…
- Trial name
- B-Fine (NCT04544956)
- Testing
- GSK3228836, Nucleos(t)ide therapy
- Where
- 4 sites in United States, Canada and 2 more
- Volunteers
- 12 people
- Sponsor
- GlaxoSmithKline