Clinical trials: Hepatitis E
HBV
Access HBV Assays - European Union (EU) Clinical Trial Protocol -
The objective of this protocol is the collection and testing of clinical samples to determine the clinical performance of the Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer.
- Trial name
- NCT04904835
- Testing
- Access HBV serological marker assays on the DxI 9000 Access Immunoassay Analyzer and CE-marked predicate assays
- Where
- 5 sites in France
- Volunteers
- 21,210 people
- Sponsor
- Beckman Coulter, Inc.
Hepatitis B, Chronic
A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment
The purpose of this study is to assess the incidence of participants who reach hepatitis B surface antigen (HBsAg) seroclearance after discontinuing nucleos(t)ide analog (NA) therapy in participants with HBsAg less than or equal…
- Trial name
- SALMONS (NCT05550519)
- Testing
- Entecavir (ETV), Tenofovir Disoproxil Fumarate (TDF), Tenofovir Alafenamide (TAF)
- Sponsor
- Janssen Pharmaceutica N.V., Belgium
Hepatitis E
Study of AT-587 in Healthy Subjects
This study will assess the safety, tolerability and pharmacokinetics (PK) of AT-587 in healthy subjects
- Trial name
- NCT07728487
- Testing
- AT-587
- Where
- Belgium
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Atea Pharmaceuticals, Inc.
Hepatitis B, Chronic
A Study of PEGASYS (Peginterferon Alfa-2a [40KD]) in Patients With Hepatitis B e Antigen (HBeAg)-Negative Chronic Hepatitis B Virus (HBV)
This study will evaluate the efficacy, safety, and tolerability of PEGASYS in participants with HBeAg-negative chronic HBV. The anticipated time on study treatment is 48 weeks, and the target sample size is 60 individuals.
- Trial name
- NCT02570191
- Testing
- Peginterferon alfa-2a
- Where
- 8 sites in Bulgaria
- Volunteers
- 60 people
- Sponsor
- Hoffmann-La Roche
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
HIV-1 Infection, HCV Infection
Efficacy, Safety, and Tolerability of Ledipasvir/Sofosbuvir (LDV/SOF) Treatment for HIV/HCV Co-infected Participants Who Switch to Elvitegravir/Cobicistat/Emtricitabine/Tenofovir Alafenamide (E/C/F/TAF) or Emtricitabine/Rilpivirine/Tenofovir Alafenamide (F/R/TAF) Prior to LDV/SOF HCV Treatment
This study will evaluate efficacy of ledipasvir/sofosbuvir (LDV/SOF) and safety and tolerability of switching to elvitegravir/cobicistat/emtricitabine/tenofovir alafenamide (E/C/F/TAF) or emtricitabine/rilpivirine/tenofovir…
- Trial name
- Co-STARs (NCT02707601)
- Testing
- E/C/F/TAF, F/R/TAF, LDV/SOF
- Where
- 43 sites in United States, Puerto Rico
- Volunteers
- 150 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
The purpose of this study is to determine the efficacy and safety of two dosages of PegIntron for treating hepatitis B e antigen (HBeAg) positive chronic hepatitis B compared with the approved dosage, which is PegIntron 1.0…
- Trial name
- NCT00536263
- Testing
- pegylated interferon alpha-2b
- Volunteers
- 671 people
- Sponsor
- Merck Sharp & Dohme LLC
HBV, Chronic HBV Infection
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Positive Hepatitis B (China)
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis…
- Trial name
- NCT02836249
- Testing
- TAF, TDF
- Where
- 25 sites in China
- Volunteers
- 181 people
- Sponsor
- Gilead Sciences
Chronic Hepatitis B
Pharmacokinetic/Pharmacodynamic of Albinterferon Alfa-2b in Chronic Hepatitis B, eAg+, Infection Subjects
This study will assess the efficacy of ABF656 in chronic hepatitis B characterized by HBeAg positivity. The study is designed to establish a dose response and safety relationship sufficient to allow the subsequent design and…
- Trial name
- NCT00964665
- Testing
- albinterferon alfa-2b, Pegasys®
- Where
- 12 sites in China, Hong Kong and 3 more
- Volunteers
- 141 people
- Sponsor
- Novartis Pharmaceuticals
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.
Chronic Hepatitis B, Hepatitis B, Chronic
Study of Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B (B-Well 2)
This study is intended to confirm the efficacy, safety, pharmacokinetic (PK) profile, and the durability of hepatitis B virus surface antigen (HBsAg) suppression observed with bepirovirsen for 24 weeks (with loading doses) as…
- Trial name
- NCT05630820
- Testing
- Bepirovirsen
- Where
- 171 sites in United States, Argentina and 25 more
- Volunteers
- 857 people
- Sponsor
- GlaxoSmithKline
Chronic Hepatitis B
A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Negative for Hepatitis B e Antigen
The purpose of this clinical research study is to assess the safety and effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen negative.
- Trial name
- NCT00035789
- Testing
- Entecavir
- Where
- 31 sites in United States
- Sponsor
- Bristol-Myers Squibb
Hepatitis E
Safety and Immunogenicity Study of Thiomersal-free Hepatitis E Vaccine in People Ages 16 Years and Above
The purpose of this study is to evaluate the safety and non-inferior immunogenicity of thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli) compared with licensed Recombinant Hepatitis E Vaccine (Escherichia Coli)…
- Trial name
- NCT06564116
- Testing
- Thiomersal-free Recombinant Hepatitis E Vaccine (Escherichia Coli), Recombinant Hepatitis E Vaccine (Escherichia Coli)
- Where
- China
- Volunteers
- 612 people, healthy volunteers welcome
- Sponsor
- Xiamen Innovax Biotech Co., Ltd
Hepatitis B, Chronic
Safety and Antiviral Activity Study of ACH-126,443 (Beta-L-Fd4C) in Treatment-naive Adults With Chronic Hepatitis B Virus Infection
The purpose of this study was to determine the safety and anti-hepatitis B virus (-HBV) activity of ACH-126,443 in comparison to lamivudine or placebo in treatment-naive adults with chronic hepatitis B infection.
- Trial name
- NCT00034359
- Testing
- ACH-126,443, Lamivudine
- Where
- 3 sites in Bulgaria, Federal Republic of Yugoslavia
- Volunteers
- 79 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Hepatitis B, Chronic
Phase II Trial for Combination Treatment of PEG-Tα1 and Adefovir for HBeAg Positive Chronic Hepatitis B
This trial is to assess the efficacy and safety of Polyethylene Glycol thymosin alpha1 (PEG-Tα1), a new long immunomodulator (Category 1.1 of Chemical Drugs) being developed from Hansoh Pharmaceutical of China, in combination…
- Trial name
- PEG-Tα1 (NCT02366208)
- Testing
- PEG-Tα1, Adefovir
- Where
- 12 sites in China
- Volunteers
- 116 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Hepatitis B, Chronic
Study of IMC-I109V in Non-cirrhotic HBeAg-negative Chronic HBV Infection
IMC-I109V is an immune-mobilizing monoclonal T cell receptor (TCR) against viruses (ImmTAV®), a new class of bispecific protein therapeutics designed for the treatment of chronic hepatitis B virus (HBV) infection (CHB).
- Trial name
- NCT05867056
- Testing
- IMC-I109V Single Ascending Dose, IMC-I109V Multiple Ascending Doses, HBV HCC Module MAD
- Where
- 15 sites in United States, Australia and 7 more
- Sponsor
- Immunocore Ltd
Hepatitis B
Efficacy and Safety of Telbivudine in Treatment naïve Patients With Hepatitis B e Antigen (HBeAg)-Positive Chronic Hepatitis B (CHB)
To evaluate the combination of telbivudine 600 mg orally (PO) once daily and peginterferon alpha-2a 180 ug subcutaneous (sq) injection weekly for antiviral efficacy in comparison to peginterferon alpha-2a monotherapy.
- Trial name
- NCT00412750
- Testing
- Telbivudine (LdT), peginterferon alpha-2a
- Where
- United States
- Volunteers
- 159 people
- Sponsor
- Novartis
Hepatitis B
A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Positive, Chronic Hepatitis B Virus Infection
Patients with HBeAG positive, chronic HBV infection will receive either ARC-520 or placebo in combination with entecavir or tenofovir, and be evaluated for safety and efficacy.
- Trial name
- NCT02604212
- Testing
- ARC-520, entecavir, antihistamine
- Where
- 16 sites in China, Germany and 1 more
- Volunteers
- 32 people
- Sponsor
- Arrowhead Pharmaceuticals
Hepatitis B, Chronic
Study of AHB-137 in Chronic Hepatitis B (CHB) Participants in North America and Europe Regions
This study is a randomized, open-label, multicenter phase 2 clinical trial to evaluate the efficacy and safety of AHB-137 injection in participants with CHB treated with Nucleos(t)ide Analogue (NAs).
- Trial name
- ASPIRE-202 (NCT07654283)
- Testing
- AHB-137
- Where
- 10 sites in United States, Canada and 4 more
- Volunteers
- 70 people
- Sponsor
- AusperBio Therapeutics Inc.
HBV, Chronic HBV Infection
Tenofovir Alafenamide Versus Tenofovir Disoproxil Fumarate for Treatment of Hepatitis B e Antigen-Negative Hepatitis B (China)
The primary objective of this study is to compare the efficacy, safety, and tolerability of tenofovir alafenamide (TAF) versus tenofovir disoproxil fumarate (TDF) in treatment-naive and treatment-experienced adults with hepatitis…
- Trial name
- NCT02836236
- Testing
- TAF, TDF
- Where
- 29 sites in China
- Volunteers
- 155 people
- Sponsor
- Gilead Sciences