NCT05494528

Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy

An, Open-label, Multicenter, Randomized, Active Control Study, Comparing P1101 Monotherapy to Entecavir Monotherapy in Patients With HBeAg-negative Chronic Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, multicenter, randomized, active control study, comparing P1101 monotherapy to entecavir monotherapy in patients with HBeAg-negative chronic hepatitis B under long-term nucleos(t)ide analogue therapy.

Detailed description

Eligible patients will be randomized in a 2:1 ratio (P1101 monotherapy vs. Entecavir monotherapy) using a computer-generated permuted block randomization scheme. Subjects will be treated with 450 µg of P1101 every two weeks or with 0.5 mg of Entecavir monotherapy once per day. Primary endpoint will be evaluated at week 48. Subjects will receive treatment with a total duration of 72 weeks. The follow-up (treatment-free) period is 24 weeks following completion of treatment. Switch from the other nucleos(t)ide analogue therapy to entecavir will occur at week 0 (Randomization), while the dose of Entecavir will be 0.5 mg.

Conditions

• Chronic Hepatitis B Virus Infection

Interventions

Type	Name	Description
DRUG	Ropeginterferon alfa-2b	Ropeginterferon alfa-2b 450 µg subcutaneous injection every two weeks
DRUG	Entecavir	Entecavir 0.5 mg once per day

Timeline

• Start date: 2021-05-04
• Primary completion: 2023-12-30
• Completion: 2024-12-30
• First posted: 2022-08-10
• Last updated: 2022-12-27

Locations

5 sites across 1 country: Taiwan