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

Sponsor
National Taiwan University Hospital
Study ID
NCT05467553
Phase
PHASE2
Status
Unknown

Conditions

  • Hepatitis D

Eligibility Criteria

Sex
ALL
Age
20 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Ursodeoxycholic acid — DRUG
    Ursodeoxycholic Acid 15 mg/kg PO QD for 60 weeks
  • Ropeginterferon alfa-2b — DRUG
    P1101 450 µg SC Q2W add-on at treatment week 12 for 48 weeks
  • Tenofovir Alafenamide — DRUG
    TAF 25 mg PO QD for 60 weeks

Study Details

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

Key Dates

Start date
Feb 24, 2023
Status verified
Jul 2022
Primary completion
Feb 28, 2025
Completion
Aug 31, 2025

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: TAF and P1101 combination therapy with UDCA
    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.
  • Active Comparator: TAF and P1101 combination therapy without UDCA
    TAF 25 mg orally (PO) QD for 60 weeks with P1101 450 µg sub-cutaneously (SC) Q2W add-on at treatment week 12 for 48 weeks.

Primary Outcome Measure

HDV RNA level [ Time Frame: Week 60 ]

Central Contacts

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