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

NCT05467553 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2022-12-29

No results posted yet for this study

Summary

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

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

Sponsors & Collaborators

  • PharmaEssentia

    collaborator INDUSTRY

  • National Taiwan University Hospital

    lead OTHER

Principal Investigators

  • Pei-Jer Chen · National Taiwan University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-02-24
Primary Completion
2025-02-28
Completion
2025-08-31

Countries

  • Taiwan

Study Locations

More Related Trials

Entities

Drugs

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 NCT05467553 on ClinicalTrials.gov