Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT04638439
PHASE1

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

View on ClinicalTrials.gov

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

Official title: A Phase Ib, Open Label Study to Assess the Safety and Efficacy of Sequential Administration of P1101 and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection

Key Details

Gender

All

Age Range

20 Years - 70 Years

Study Type

INTERVENTIONAL

Enrollment

20

Start Date

2022-08-17

Completion Date

2026-04-08

Last Updated

2026-06-10

Healthy Volunteers

No

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.

Locations (5)

Chia-Yi Christian Hospital

Chiayi City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Medical University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

Chang Gung Memorial Hospital, Linkou

Taoyuan City, Taiwan