The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection

PHASE1CompletedINTERVENTIONAL
Enrollment

20

Participants

Timeline

Start Date

August 17, 2022

Primary Completion Date

May 14, 2025

Study Completion Date

May 14, 2025

Conditions
Chronic Hepatitis B InfectionChronic Hepatitis D Infection
Interventions
DRUG

P1101 + Nivolumab + Entecavir

P1101 (Ropeginterferon alfa-2b) 450 µg subcutaneously (SC) Q2W for 6 doses (12 weeks), followed by 0.3 mg/kg Nivolumab for 6 doses (12 weeks), with a follow up of 24 weeks. All patients will also receive Entecavir 0.5 mg QD from Day 1 to Follow-up 24.

Trial Locations (5)

Unknown

Chia-Yi Christian Hospital, Chiayi City

National Taiwan University Hospital, Taipei

Taipei Medical University Hospital, Taipei

Taipei Veterans General Hospital, Taipei

Chang Gung Memorial Hospital, Linkou, Taoyuan

Sponsors

Lead Sponsor

All Listed Sponsors
lead

PharmaEssentia

INDUSTRY