Hepatitis B, Chronic Clinical Trial
Official title:
A Phase II Randomized, Double-blind, Placebo-controlled, Multi-center Study of Finite Therapy of TAF in Combination With PEG-IFN and Hepalatide in Subjects With Chronic Hepatitis B
The study is designed to assess efficacy of hepalatide in Combination with Pegylated Interferon and TAF compared to Pegylated Interferon in Combination with TAF in patients with Chronic Hepatitis B .Subjects will be randomly assigned to the hepalatide or placebo groups , 15 subjects in each group . Subjects will receive hepalatide+Pegylated Interferon +TAF treatment for 48 weeks or placebo +Pegylated Interferon +TAF treatment for 48 weeks , followed by a safety follow-up for 24 weeks.
Hepalatide is a liver-targeted antiviral therapeutic for subcutaneous injection designed to treat chronic hepatitis B virus (HBV) infection. Pegylated interferon and TAF are approved drugs for the treatment of chronic HBV infection . The primary hypothesis of this study is that combination regimen of hepalatide+NA+Pegylated interferon is more efficacious than NA+Pegylated interferon treatment , as measured by the primary efficacy endpoint. This study will be conducted in 3 periods: Screening Period (4weeks), Treatment Period (48 weeks) and Follow-up (FU) Period (24 weeks). Safety assessments will include adverse events (AEs), serious AEs, clinical safety laboratory tests, electrocardiograms (ECGs), vital signs, ophthalmologic examinations and physical examinations. Total duration of individual participation will be up to 76 weeks (including screening period). ;
| 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 |
NCT01023230 -
A Study to Assess DV-601 in Subjects With Chronic Hepatitis B
|
Phase 1 | |
| Completed |
NCT00962975 -
A Study of Pegasys Monotherapy in Patients With Chronic Hepatitis B Who Have Participated in Previous Studies
|
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 |