NCT04568265

A Clinical Study of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B

A Multicenter, Open-label, Phase II Clinical Study to Evaluate the Safety and Efficacy of APG-1387 in Combination With Entecavir in Patients With Chronic Hepatitis B

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 122 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Hepatitis B
• Chronic Hep B
• HBV

Interventions

Type	Name	Description
DRUG	APG-1387	Weekly intravenous infusion for 30 minutes
DRUG	Entecavir 0.5 mg	Taken daily by mouth

Timeline

• Start date: 2020-06-03
• Primary completion: 2022-10-31
• Completion: 2025-10-31
• First posted: 2020-09-29
• Last updated: 2021-08-26

Locations

4 sites across 1 country: China

Regulatory

• FDA-regulated drug study