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

Sponsor
National Taiwan University Hospital
Study ID
NCT05494528
Status
Unknown

Conditions

  • Chronic Hepatitis B Virus Infection

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ropeginterferon alfa-2b — DRUG
    Ropeginterferon alfa-2b 450 µg subcutaneous injection every two weeks
  • Entecavir — DRUG
    Entecavir 0.5 mg once per day

Study Details

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.

Key Dates

Start date
May 4, 2021
Status verified
Mar 2022
Primary completion
Dec 30, 2023
Completion
Dec 30, 2024

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ropeginterferon alfa-2b monotherapy
    Subjects will be treated with 450 µg of Ropeginterferon alfa-2b every two weeks
  • Active Comparator: Entecavir monotherapy
    Subjects will be treated with 0.5 mg of Entecavir monotherapy once per day

Primary Outcome Measure

Undetectable HBsAg [ Time Frame: Week 48 ]

Central Contacts