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

Sponsor
PharmaEssentia
Study ID
NCT04638439
Phase
PHASE1
Status
Completed

Conditions

  • Chronic Hepatitis B Infection
  • Chronic Hepatitis D Infection

Eligibility Criteria

Sex
ALL
Age
20 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • P1101 + Nivolumab + Entecavir — DRUG
    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.

Study Details

Primary objective: To evaluate the safety and tolerability of sequential administration of P1101 and anti-PD1 in patient with chronic hepatitis B or D infection Secondary objectives: 1. To explore HBsAg loss and kinetics during the study period 2. To assess the anti-viral effect during the study period 3. To evaluate the rate of ALT normalization

Key Dates

Start date
Aug 17, 2022
Status verified
Jun 2026
Primary completion
Apr 8, 2026
Completion
Apr 8, 2026

Study Design

Enrollment
20 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: P1101 + Nivolumab + Entecavir

Primary Outcome Measure

Safety: AE/SAE [ Time Frame: Through study Follow-up Week 24 (up to 330 days) ]

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