Clinical Trials Logo

Clinical Trial Summary

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.


Clinical Trial Description

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). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05133856
Study type Interventional
Source Shanghai HEP Pharmaceatical Co., Ltd.
Contact Fei Cai
Phone 86-21-68412368
Email caifei_hep@163.com
Status Not yet recruiting
Phase Phase 2
Start date December 2021
Completion date June 2024

See also
  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