Clinical trials: Chronic HBV Infection (HBeAg Negative)
Hepatitis B
Phase I Safety and Immunogenicity of FP-02.2 in Chronic Hepatitis B
This study evaluates the safety and immunogenicity of FP-02.2, a new therapeutic Hepatitis B vaccine, administered as an add-on therapy to entecavir or tenofovir.
- Trial name
- NCT02496897
- Testing
- FP-02.2 Vaccine, IC31® Adjuvant
- Where
- 21 sites in South Korea, United Kingdom
- Volunteers
- 61 people
- Sponsor
- Altimmune, Inc.
Chronic Hepatitis B
Inactive HBsAg Carriers (IHCs) Treated With Pegylated Interferon α2b Based Intervention Therapy
A single center, randomized controlled trial design was used to select patients with chronic hepatitis B in the immune control period (HBsAg positive, HBeAg negative, normal ALT, HBsAg ≤ 1500iu/ml, HBV DNA ≤ 2000iu/ml) to enter…
- Trial name
- NCT05451420
- Testing
- PegIFN α- 2b
- Where
- China
- Volunteers
- 33 people
- Sponsor
- Henan Provincial People's Hospital
Chronic Hepatitis B Virus Infection
Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy
This is an open-label, multicenter, randomized, active control study, comparing P1101 monotherapy to entecavir monotherapy in patients with HBeAg-negative chronic hepatitis B under long-term nucleos(t)ide analogue therapy.
- Trial name
- NCT05494528
- Testing
- Ropeginterferon alfa-2b, Entecavir
- Where
- 5 sites in Taiwan
- Volunteers
- 90 people
- Sponsor
- National Taiwan University Hospital
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
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
Chronic Hepatitis B
A Study of ABI-H0731 + Nucleos(t)Ide as Finite Treatment for Chronic Hepatitis B Patients
Open-label, extension study to evaluate the safety and efficacy of combination therapy and its effect on sustained viral response biomarkers.
- Trial name
- NCT03780543
- Testing
- standard of care (SOC) Nucleoside reverse transcriptase inhibitor (NrtI)
- Where
- 24 sites in United States, Canada and 3 more
- Volunteers
- 92 people
- Sponsor
- Assembly Biosciences
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 B
Combination Therapy of Pegylated Interferon Alfa-2a and Tenofovir Versus Tenofovir Monotherapy in Chronic Hepatitis B
This clinical trial compares the efficacy of peginterferon plus tenofovir for 24 weeks followed by monotherapy with tenofovir for a further 3.5 years to the efficacy of tenofovir alone given for 4 years in patients with chronic…
- Trial name
- HBRN (NCT01369212)
- Testing
- Tenofovir, Peginterferon-alfa 2a and tenofovir
- Where
- 21 sites in United States, Canada
- Volunteers
- 201 people
- Sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
CHRONIC HEPATITIS B
A Trial To Study The Effect Of Lamivudine In Adult Patients Who Suffer From Chronic Hepatitis B Alone
The efficacy of lamivudine in Hepatitis Be Antigen (HBeAg) positive Asian patients of chronic hepatitis has been well established.The evidence in HBeAg negative patients is limited.
- Trial name
- NCT00354653
- Testing
- LAMIVUDINE
- Where
- Iran
- Volunteers
- 100 people
- Sponsor
- ViiV Healthcare
Chronic Hepatitis B
Pegylated Interferon Alfa-2b in Reducing Relapse Rates After Nucleos(t)ide Analogue Withdrawal in HBeAg-negative CHB Patients with Low Level HBsAg
All enrolled patients must meet the European Guidelines for the Prevention and Treatment of Chronic Hepatitis B (EASL, 2017) recommended discontinuation criteria, that is, HBeAg-negative chronic hepatitis B patients without…
- Trial name
- NCT06900166
- Testing
- PegIFN alfa-2b, PegIFN alfa-2b and NUC
- Where
- China
- Volunteers
- 360 people
- Sponsor
- Huashan Hospital
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
Hepatitis B, Chronic
Study to Evaluate the Efficacy and Safety of AHB-137 Injection in Participants With Chronic Hepatitis B (CHB).
AB-10-8003 is a randomized, multi-center phase II study to evaluate the efficacy and safety of AHB-137 in subjects with HBeAg-negative CHB under stable NA treatment.
- Trial name
- NCT06550128
- Testing
- AHB-137 (24 weeks), AHB-137 (16 weeks)
- Where
- 6 sites in China
- Volunteers
- 86 people
- Sponsor
- Ausper Biopharma Co., Ltd.
Hepatitis B, Chronic
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
This randomized, 2 x 2 factorial, parrallel group study will compare the efficacy and safety of 48 versus 96 weeks of peginterferon alfa-2a [Pegasys], with or without entecavir, in patients with HbeAg negative chronic hepatitis…
- Trial name
- NCT01179594
- Testing
- entecavir, peginterferon alfa-2a [Pegasys]
- Sponsor
- Hoffmann-La Roche
Chronic Hepatitis B
Pegylated Interferon Alpha-2b Monotherapy Versus Combination With Entecavir in HBeAg-negative Chronic Hepatitis B
The outcome of treatment of chronic hepatitis B is determined by viral and host interaction, thus the combination therapy of immunomodulator (PEG-IFN) and potent antiviral drug (entecavir) should improve the response rate.
- Trial name
- NCT01243281
- Testing
- PEG-IFN and entecavir
- Where
- Thailand
- Volunteers
- 126 people
- Sponsor
- Chulalongkorn University
Hepatitis B, HBV
Evaluating the Safety and Efficacy of Inarigivir in Non-cirrhotic, Hepatitis B e Antigen-negative Subjects Infected With HBV Virus and Receiving or Stopping Treatment With a NUC Inhibitor
An open-label, Phase 2, exploratory study to examine the safety and efficacy of inarigivir in non-cirrhotic, hepatitis B e antigen (HBeAg)-negative subjects with chronic HBV infection.
- Conditions
- Hepatitis B, HBV, Hepatitis B, Chronic
- Trial name
- NCT04023721
- Testing
- Inarigivir soproxil, Nucleoside/nucleotide (NUC) analogue inhibitors
- Where
- 7 sites in Canada, United Kingdom
- Volunteers
- 64 people
- Sponsor
- F-star Therapeutics, Inc.
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
Chronic Hepatitis B, HBeAg Negative
Terminator 2 Register
All patients with chronic HBeAg negative hepatitis B treated with nucleos(t)ide analogues, who discontinue treatment based in the criteria outlined in the EASL hepatitis B guidelines shall be included in the present study.
- Trial name
- NCT03643172
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- Hannover Medical School
Hepatitis B, Chronic
Long-term Safety and Efficacy of Tenofovir Amibufenamide in Patients With CHB
Tenofovir amibufenamide (TMF) is a novel prodrug of tenofovir that has been widely used in mainland China for the treatment of chronic hepatitis B (CHB).
- Trial name
- NCT06743438
- Testing
- Tenofovir Amibufenamide（TMF）
- Where
- China
- Volunteers
- 640 people
- Sponsor
- Jiangsu Hansoh Pharmaceutical Co., Ltd.
Chronic Hepatitis B
Efficacy & Safety of Tenofovir Disoproxil Fumarate (TDF) Plus Peginterferon α-2a (Peg-IFN) Versus TDF or Peg-IFN Monotherapy in Chronic Hepatitis B
The primary objective of this study is to evaluate the efficacy of tenofovir disoproxil fumarate (TDF) plus peginterferon α-2a (Peg-IFN) combination therapy for 48 weeks versus standard of care TDF monotherapy or Peg-IFN…
- Trial name
- NCT01277601
- Testing
- TDF, Peg-IFN
- Where
- 171 sites in United States, Australia and 17 more
- Volunteers
- 751 people
- Sponsor
- Gilead Sciences
Hepatitis B, Chronic
SOFIA-LTT Study: A Study of Intermittent Long Term Treatment With PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With HBeAg Negative Chronic Hepatitis B (CHB).
This 2 arm study will evaluate the efficacy and safety of intermittent treatment with PEGASYS in HBeAg negative patients with chronic hepatitis B who have demonstrated virological and biochemical response after treatment with…
- Trial name
- NCT00442572
- Testing
- PEGASYS [peginterferon alfa-2a]
- Where
- Bulgaria
- Volunteers
- 21 people
- Sponsor
- Hoffmann-La Roche