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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

NCT04638439 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-07-02

No results posted yet for this study

Summary

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

Conditions

  • Chronic Hepatitis B Infection
  • Chronic 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.

Sponsors & Collaborators

  • PharmaEssentia

    lead INDUSTRY

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-08-17
Primary Completion
2025-05-14
Completion
2025-05-14

Countries

  • Taiwan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04638439 on ClinicalTrials.gov