NCT05467553View on ClinicalTrials.gov

A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection

PHASE2UnknownINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

February 24, 2023

Primary Completion Date

February 28, 2025

Study Completion Date

August 31, 2025

Conditions
Hepatitis D
Interventions
DRUG

Ursodeoxycholic acid

Ursodeoxycholic Acid 15 mg/kg PO QD for 60 weeks

DRUG

Ropeginterferon alfa-2b

P1101 450 µg SC Q2W add-on at treatment week 12 for 48 weeks

DRUG

Tenofovir Alafenamide

TAF 25 mg PO QD for 60 weeks

Trial Locations (2)

Unknown

National Taiwan University Hospital, Taipei

Taipei Medical University Hospital, Taipei

Sponsors

Collaborators (1)

PharmaEssentia
All Listed Sponsors
collaborator

PharmaEssentia

INDUSTRY

lead

National Taiwan University Hospital

OTHER

NCT05467553 - A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection | Biotech Hunter | Biotech Hunter