Hepatitis B, Chronic Clinical Trial
Official title:
A Phase 2, Single-blinded, Randomised, Controlled Multi-country Study to Evaluate the Safety, Reactogenicity, Efficacy and Immune Response Following Sequential Treatment With an Anti-sense Oligonucleotide (ASO) Against Chronic Hepatitis B (CHB) Followed by Chronic Hepatitis B Targeted Immunotherapy (CHB-TI) in CHB Patients Receiving Nucleos(t)Ide Analogue (NA) Therapy
This study will assess the safety, efficacy and immune response following the sequential treatment of GlaxoSmithKline's (GSK) ASO compound (GSK3228836) and CHB-TI (GSK3528869A) in participants 18 to 65 years stable on NA treatment for CHB. The aim is to quantify the efficacy of sequential therapy as well as to determine an added value of sequential therapy over GSK3228836 therapy in CHB patients treated with NAs. In addition, the study will assess the effect of different treatment durations of GSK3228836 (12 or 24 weeks) prior to initiating GSK3528869A treatment.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03272009 -
Evaluation of the Safety and Pharmacology of EYP001 in HBV Subjects
|
Phase 1 | |
| Recruiting |
NCT01456312 -
HBsAg Related Response Guided Therapy
|
Phase 4 | |
| Terminated |
NCT01886300 -
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive Chronic Hepatitis B in Vietnam
|
N/A | |
| Completed |
NCT00962975 -
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
|
Phase 1 | |
| Completed |
NCT01023230 -
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
|
Phase 1 | |
| Terminated |
NCT00460850 -
A Study of PEGASYS (Peginterferon Alfa-2a (40KD)) in Patients With Lamivudine Resistant HBeAg-Negative Chronic Hepatitis B.
|
Phase 4 | |
| Completed |
NCT00536263 -
PegIntron Treatment of Chronic Hepatitis B e Antigen-Positive Patients (P05170/MK-4031-327)
|
Phase 3 | |
| Completed |
NCT03681132 -
The Norwegian Nucleoside Analogue Stop Study
|
Phase 4 | |
| Active, not recruiting |
NCT05473806 -
Effects of Pioglitazone and Evogliptin on Hepatic Fibrosis in Patients With Chronic Hepatitis B With Type 2 Diabetes
|
Phase 4 | |
| Withdrawn |
NCT01179594 -
A Study of 48 Versus 96 Weeks of Peginterferon Alfa-2a [Pegasys] Treatment, With or Without Entecavir, in Patients With Chronic Hepatitis B.
|
Phase 4 | |
| Recruiting |
NCT05057065 -
A Clinical Research on Disease Progression and Intervention of Chronic HepatitisB
|
||
| Completed |
NCT04439539 -
A Study of JNJ-73763989, Pegylated Interferon Alpha-2a, Nucleos(t)Ide Analog (NA) With or Without JNJ-56136379 in Treatment-naive Participants With Hepatitis B e Antigen (HBeAg) Positive Chronic Hepatitis B Virus (HBV) Infection
|
Phase 2 | |
| Withdrawn |
NCT03125213 -
A Study Evaluating AL-3778 in Combination With Peginterferon Alpha-2a in Chronic Hepatitis B Subjects
|
Phase 2 | |
| Active, not recruiting |
NCT04782375 -
Safely Discontinue Antiviral Treatment in Patients With Chronic Hepatitis B
|
Phase 4 | |
| Withdrawn |
NCT05550519 -
A Study in Chronic Hepatitis B e-Antigen Negative Participants After Discontinuation of Nucleos(t)Ide Analog (NA) Treatment
|
Early Phase 1 | |
| Completed |
NCT02693652 -
A Study to Evaluate the Safety and Efficacy of Therapeutic Hepatitis B Vaccine
|
Phase 1/Phase 2 | |
| Enrolling by invitation |
NCT04160897 -
Risk of Hepatocellular Carcinoma in Patients Treated With ETV vs TDF for Chronic Hepatitis B With Compensated Cirrhosis
|
||
| Active, not recruiting |
NCT02588937 -
Active Drug Comparative Trial to Evaluate the Antiviral Activity and Safety in Chronic Hepatitis B Patients
|
Phase 4 | |
| Completed |
NCT02612506 -
Safety and Pharmacokinetic Study of Hepalatide(L47) in Healthy Volunteers
|
Phase 1 | |
| Recruiting |
NCT02327416 -
A Prospective Clinical Trial in Chronic Hepatitis B Patients NAs (Nucleotides or Nucleosides) Experienced (Anchor Study)
|
Phase 3 |