Clinical Trials Logo

Clinical Trial Summary

This study is a multicenter, open-label, phase II clinical study in subjects with chronic hepatitis B (CHB), to characterize the safety, tolerability, pharmacokinetic profile and preliminary anti-hepatitis B virus (HBV) efficacy of APG-1387 in combination with entecavir, and to determine the optimal dose of APG-1387 in combination with entecavir.


Clinical Trial Description

The study is divided into two parts: Part 1 will evaluate the safety, tolerability, and pharmacokinetics of APG-1387 in combination with entecavir, including determination of the maximum tolerated dose (MTD)/ recommended dose in patients with CHB. APG-1387 will be administered once weekly via intravenous infusion for 30 minutes for consecutive 4 weeks. APG-1387 will be escalated at 3 dose cohorts of 12 mg, 20 mg, and 30 mg. Entecavir will be administered orally at 0.5 mg daily for 12 weeks: in combination with APG-1387 for the first 4 weeks, followed by entecavir maintenance monotherapy for additional 8 weeks. The total treatment duration will be 12 weeks. Part 2 is a randomized, parallel, open-label study to investigate the preliminary anti-HBV efficacy of APG-1387 in combination with entecavir compared with entecavir monotherapy. CHB subjects will be randomly assigned to one of 4 cohorts at 1:1:1:1, including APG-1387 at 3 different doses (12 mg, 20 mg, and 30 mg) in combination with entecavir for 12 weeks, respectively, then continued entecavir monotherapy for additional 12 weeks; and one entecavir monotherapy cohort for 24 weeks. The course of treatment is 24 weeks in all cohorts. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04568265
Study type Interventional
Source Ascentage Pharma Group Inc.
Contact
Status Recruiting
Phase Phase 2
Start date June 3, 2020
Completion date October 31, 2025

See also
  Status Clinical Trial Phase
Completed NCT01182311 - Duration of Long-term Immunity After Hepatitis B Virus Immunization
Completed NCT04971928 - Phase 1 Study of GSK3228836 Pharmacokinetics in Participants With Hepatic Impairment Phase 1
Completed NCT03285620 - A Study of AL-034 to Evaluate the Safety, Tolerability and Pharmacokinetics of Single and Multiple Doses in Healthy Participants Phase 1
Completed NCT01884415 - Phase III, Study to Evaluate the Efficacy of Two Different HBV Vaccination Schemes in Patients With Hepatic Cirrhosis Phase 3
Recruiting NCT05404919 - Utilization of Hepatitis B Virus NAT+ Donors for Hepatitis B Vaccinated Lung Transplant Candidates Phase 2
Completed NCT02153320 - Study to Evaluate the Persistence of the Cellular and Humoral Immune Response Following Vaccinations With GlaxoSmithKline (GSK) Biologicals' Candidate Vaccines Containing HBsAg and Different Adjuvants in Healthy Adult Volunteers Phase 1
Completed NCT00352963 - Immunogenicity & Safety Study of Combined/Separate Vaccine(s) Against Common Diseases in Infants (2,4,6 Months of Age). Phase 3
Completed NCT03567382 - Arresting Vertical Transmission of Hepatitis B Virus Phase 4
Not yet recruiting NCT04056728 - A Phase IV Study to Assess the Safety of EupentaTM Inj Phase 4
Not yet recruiting NCT03604016 - Study to Assess Efficacy of Besifovir and L-carnitine in Chronic Hepatitis B Patients With Nonalcoholic Fatty Liver Phase 4
Completed NCT00753649 - Immunogenicity and Safety of GSK Biologicals' Infanrix Hexa in Infants Phase 4
Recruiting NCT03027258 - Point-of-Delivery Prenatal Test Results Through mHealth to Improve Birth Outcome N/A
Completed NCT02540538 - Safety and Immunogenicity of HBAI20 Hepatitis B Vaccine in Naive Adults and Non-responders Phase 1
Terminated NCT02604199 - A Multi-dose Study of ARC-520 in Patients With Hepatitis B 'e' Antigen (HBeAg) Negative, Chronic Hepatitis B Virus (HBV) Infection Phase 2
Completed NCT02421666 - A Comparative Trial of Improving Care for Underserved Asian Americans Infected With HBV N/A
Completed NCT02169674 - Hepatitis B Booster Study in Adolescence Phase 4
Completed NCT01917357 - A Comparison of the Immunogenicity and Safety of Quinvaxem in Mono-dose Vials and Uniject Phase 3
Completed NCT01368497 - Entecavir/Pegylated Interferon in Immune Tolerant Children With Chronic Hepatitis B Virus (HBV) Infection Phase 3
Completed NCT01732354 - Study for Consolidation Period of Chronic Hepatitis B
Recruiting NCT01462981 - Cohort of Hepatitis B Research of Amsterdam N/A