Chronic Hepatitis B Clinical Trial
Official title:
Phase 3 Multicenter, Randomized, Double-Blind, Study to Assess the Efficacy and Safety of Treatment With Bepirovirsen in Nucleos(t)Ide Analogue-treated Participants With Chronic Hepatitis B Virus (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 compared to the placebo arm. This study will have 4 stages: a) Double-blind treatment (bepirovirsen or placebo) for 24 weeks. b) Nucleos(t)ide analogue (NA) treatment for 24 weeks. c) NA cessation stage OR Continue NA for 24 weeks. d) Durability of response and follow up for further 24 weeks for participants who stopped NA treatment at Week 48. The arms will be stratified based on HBsAg level (HBsAg greater than or equal to [≥] 100 international unit per milliliter [IU/mL] to less than or equal [≤]1000 IU/mL or greater than [>] 1000 IU/mL to ≤3000 IU/mL) at screening. The total duration of the study, including screening (up to 60 days), the double-blind treatment stage (24 weeks), the On NA only stage (24 weeks), and the NA cessation and durability stages (48 weeks) is up to approximately 104 weeks at maximum for each participant.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT04496882 -
Chronic Hepatitis b Patients Switch to tAf After Discontinuation of Nucleoside Analogue
|
Phase 4 | |
| Completed |
NCT04083716 -
A Study to Assess the Relative Bioavailability and Food Effect of ABI-H2158 in Healthy Adults
|
Phase 1 | |
| Not yet recruiting |
NCT03038802 -
A Randomised Controlled Phase 1 Study of Vaccine Therapy for Control or Cure of Chronic Hepatitis B Virus Infection
|
Phase 1/Phase 2 | |
| Completed |
NCT05310487 -
Phase 1 Study of 162, a Novel Neutralizing Antibody Targeting Hepatitis B Surface Antigen, in Healthy Adult Subjects
|
Phase 1 | |
| Recruiting |
NCT06070051 -
Dose-Escalation Prime/Boost Therapeutic Vaccination Study Of 2 Chimp Adenoviral Vectors in Adults With Chronic HBV On Nucleos(t)Ide Therapy
|
Phase 1 | |
| Terminated |
NCT05001022 -
A Study of ALG-020572 Drug to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics After Single Doses in Healthy Volunteers and Multiple Doses in CHB Subjects
|
Phase 1 | |
| Recruiting |
NCT04139850 -
The Establishment of Korean Hepatitis B Patients Cohort
|
||
| Recruiting |
NCT05343481 -
Efficacy of VTP-300 in Chronic Hepatitis B Infection
|
Phase 2 | |
| Not yet recruiting |
NCT05490836 -
Functional Cure Rate of Peg-IFNα-2b Combined With TAF in HBeAg Negative CHB Patients
|
N/A | |
| Recruiting |
NCT04543565 -
Pradefovir Treatment for the Patients With Chronic Hepatitis B Virus Infections: a Phase3 Study
|
Phase 3 | |
| Active, not recruiting |
NCT02894918 -
A Study to Evaluate Addition of Peginterferon Alfa-2a to Chronic Hepatitis B (CHB) Patients Treated With NAs
|
Phase 4 | |
| Not yet recruiting |
NCT02793791 -
Prophylactic Treatment of Hepatic Dysplastic Nodules in HBsAg Positive Patients
|
N/A | |
| Recruiting |
NCT02287857 -
Efficacy and Safety of Domestic Tenofovir Tablets in Chinese Patients With Chronic Hepatitis B
|
N/A | |
| Recruiting |
NCT01965418 -
A Clinical Evaluation on Traditional Chinese Medicine Diagnosis and Treatment Program Blocking and Reversing Hepatitis B-related Liver Fibrosis - a Randomized, Controlled, Double-blind, Multi-center Clinical Trial
|
Phase 4 | |
| Recruiting |
NCT01491295 -
Switch to Tenofovir Versus Continue Lamivudine/Adefovir Treatment in Lamivudine-resistance Chronic Hepatitis B Patients
|
Phase 4 | |
| Terminated |
NCT01872988 -
Tenofovir Antiviral Therapy Following Transarterial Chemoembolization for HBV Related Hepatocellular Carcinoma
|
Phase 3 | |
| Recruiting |
NCT01487876 -
Efficacy and Safety of Dual-plasmid Hepatitis B Virus DNA Vaccine in Chronic Hepatitis B Patients
|
Phase 2 | |
| Completed |
NCT01531166 -
A Cohort Study in Korean Patients With Chronic Hepatitis B (CHB) Receiving Pegylated Interferon
|
N/A | |
| Not yet recruiting |
NCT01436539 -
Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients
|
Phase 4 | |
| Recruiting |
NCT01360892 -
Prediction of Incidence of Liver Cancer by Use of Real-time Tissue Elastography
|
N/A |