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

Hepatitis D Clinical Trial

Official title:
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

Clinical Trial Summary

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

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05467553
Study type Interventional
Source National Taiwan University Hospital
Contact Pei-Jer Chen
Phone 886-2-23123456
Email peijerchen@ntu.edu.tw
Status Not yet recruiting
Phase Phase 2
Start date February 24, 2023
Completion date August 31, 2025
View Details
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