NCT05467553

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

An Open-label, Randomized Study to Compare the Efficacy and Safety of P1101 Plus Tenofovir Alafenamide With or Without Ursodeoxycholic Acid in Patients With Chronic Hepatitis B and Hepatitis D Virus Co-Infection

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: National Taiwan University Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This is an open-label, randomized, multi-center study in patients with chronic HBV and HDV co-infection.

Detailed description

There will be 2 treatment groups in this study, 15 subjects per group as follows: Group 1: TAF 25 mg orally (PO) QD for 60 weeks with P1101 450 µg subcutaneously (SC) Q2W add-on at treatment week 12 for 48 weeks. Group 2: Ursodeoxycholic Acid (UDCA)\* 15 mg/kg orally (PO) QD plus TAF 25 mg orally (PO) QD for 60 weeks, with P1101 450 µg subcutaneously (SC) Q2W add-on at treatment week 12 for 48 weeks. Both groups will have a post-treatment follow-up of 24 weeks. \*: Dose of Ursodeoxycholic Acid (UDCA) will be determined by weight at Day 1 (TW0) in 2-4 divided doses.

Conditions

• Hepatitis D

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-02-24
• Primary completion: 2025-02-28
• Completion: 2025-08-31
• First posted: 2022-07-20
• Last updated: 2022-12-29

Locations

2 sites across 1 country: Taiwan