UnknownPhase 2

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

Taiwan30 participantsStarted 2023-02-24

Plain-language summary

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

Who can participate

Age range

20 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Positive for HBsAg for at least 6 months, either HBeAg(+) or HBeAg(-), and positive for anti-HDV with detectable HDV RNA and ALT ≥ ULN to ≤ 10X ULN at screening.
. Interferon treatment naïve.
. Willing and able to provide written informed consent.
. Age 20-75 years old; subjects who are over 70 years of age must be in generally good health.
. Laboratory test results before study entry: WBC ≥ 3,000/mm3; ANC ≥ 1,500/mm3; Platelet ≥ 90,000/mm3; Hemoglobin ≥ 10g/dL; e-GFR ≥ 60mL/min.
. ECG without clinically significant abnormalities before study entry.
. Be able to attend all scheduled visits and to comply with all study procedures.
. Patients with anti-HCV(+) or anti-HIV(+) can be enrolled if:

Exclusion criteria

. Clinically significant illness or surgery that might interfere with study participation.
. Clinically significant vital sign abnormalities, uncontrolled hypertension, or fever \[body temperature \>38 degrees Celsius\].

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

HDV RNA level

Timeframe: Week 60

ALT level

Timeframe: Week 60

Trial details

NCT IDNCT05467553

SponsorNational Taiwan University Hospital

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-02-28

Contact for this trial

Pei-Jer Chen

886-2-23123456 peijerchen@ntu.edu.tw

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