Hepatitis DPhase 2NCT05467553
A Study to Compare P1101 Plus TAF With or Without UDCA in Patients With HBV and HDV Co-Infection
A Phase 2 study testing Ursodeoxycholic acid, Ropeginterferon alfa-2b and Tenofovir Alafenamide in people with Hepatitis D, run by National Taiwan University Hospital at 2 sites in Taiwan.
Trial summary
This is an open-label, randomized, multi-center study in patients with chronic HBV and HDV co-infection. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Hepatitis D
- What is being tested?
- Ursodeoxycholic acid, Ropeginterferon alfa-2b and Tenofovir Alafenamide
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 2 sitesTaiwan
- Study dates
- 24 Feb 2023to 31 Aug 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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:
- anti-HCV(+) with undetectable HCV RNA ≥ 3 months.
- anti-HIV(+) with undetectable HIV viral load (either with or without Highly Active Anti- Retroviral Therapy, HAART).
Who cannot join
- 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].
- History of significant alcohol or drug abuse within 6 months prior to the screening visit (alcohol consumption of more than 14 units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]) or refusal to abstain from alcohol or illicit drugs throughout the study.
- Any history or presence of poorly controlled or clinically significant medical conditions that are not suitable to receive interferon-based treatment, at the discretion of the investigator: major psychiatric (including but not limited to those with severe depression, severe bi-polar disorder, schizophrenia, suicidal ideation or history of suicidal attempt), neurological, cardiovascular, pulmonary, hematologic, immunologic, autoimmune diseases, thyroid or other endocrine diseases, metabolic (e.g. diabetes mellitus with HbA1C > 8.0%) or other uncontrolled systemic disease, coagulation disorders or blood dyscrasias.
- Pregnant subject; female subject who are breast feeding or lactating; female subject or the spouse of male subject, with child-bearing potential who is unwilling or unable to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicides, or birth control pills, or intrauterine devices throughout the study.
- History of severe allergic or hypersensitivity reactions, e.g. hypersensitivity to the active substance or to any of the excipients of ropeginterferon alfa 2b, ursodeoxycholic acid, tenofovir disoproxil fumarate and tenofovir alafenamide.
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- Therapy with any systemic anti-viral treatment, anti-neoplastic, or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 1 month (3 months for those with long elimination half-lives) prior to the first dose of study drug.
- A depot injection or an implant of any drug within 3 months prior to administration of study medication, other than contraception or hyaluronic acid injections in joints for osteoarthritis.
- Body organ transplant or taking immunosuppressant.
- Use of an investigational drug within 4 weeks prior to the first dose of the study drug.
- History of malignancy diagnosed or treated within 5 years prior to screening (except for localized treatment of squamous or non-invasive basal cell skin cancers; cervical carcinoma in situ); cancer survivors not on maintenance therapy within the past 5 years.
- History of opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia).
- Serious localized infection (e.g., cellulitis, abscess) or systemic and life-threatening infection (e.g., septicemia) within 3 months prior to screening.
- Clinically significant medical conditions known to interfere absorption, distribution, metabolism or excretion of the study drugs.
- Decompensated liver disease, which includes but not limited to the following: total bilirubin ≥ 2 mg/dL (except in Gilbert syndrome), direct bilirubin ≥ 2X ULN, albumin level < 3.5 g/dL, INR ≥ 1.5; clinical evidence of ascites, liver decompensation, hepatic encephalopathy, oesophageal varices or cirrhosis as identified by ultrasound or any other examination before study entry.
- Significant steatohepatitis by ultrasound or other examination at the discretion of investigator.
- Other form of significant chronic liver diseases, except those mentioned above.
- Significant or major fundoscopic findings at screening including but not limited to retinal exudates, hemorrhage, detachment, neovascularization, papilloedema, optic atrophy, microaneurysms and macu-lar changes.
- Patients with complete biliary obstruction, chololithiasis, severe pancreatic disease or peptic ulcer.
- Patients treated by monotherapy of telbivudine/TDF/TAF/adefovir dipivoxil or any other combination therapy with telbivudine/TDF/TAF/adefovir dipivoxil within 1 month prior to screening.
- Patient who vaccination with any live attenuated vaccine within 1 month prior to screening.
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
National Taiwan University Hospital
Taipei
Pei-Jer Chen, 886-2-23123456 ext. 67072, peijerchen@ntu.edu.tw
Taipei Medical University Hospital
Taipei
Yi-Wen Huang, 886-2-27372181 ext. 3577, yiwenhuang@tmu.edu.tw
About this study
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
This is an open-label, randomized, multi-center study in patients with chronic HBV and HDV co-infection.
Read the 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
- Being tested
- Ursodeoxycholic acid, Ropeginterferon alfa-2b, Tenofovir Alafenamide
- Keywords
- Ropeginterferon alpha-2b, Hepatitis D, UDCA, TAF
- Medical subject headings
- Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ursodeoxycholic acidDrug
Also called Uroso Tablets
Ursodeoxycholic Acid 15 mg/kg PO QD for 60 weeks
Ropeginterferon alfa-2bDrug
Also called BESREMI
P1101 450 µg SC Q2W add-on at treatment week 12 for 48 weeks
Tenofovir AlafenamideDrug
Also called Vemlidy
TAF 25 mg PO QD for 60 weeks
| Study group | Role | What they receive |
|---|---|---|
| TAF and P1101 combination therapy with UDCA | Experimental | 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. Receives: Drug: Ursodeoxycholic acid; Drug: Ropeginterferon alfa-2b; Drug: Tenofovir Alafenamide |
| TAF and P1101 combination therapy without UDCA | Active comparator | 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. Receives: Drug: Ropeginterferon alfa-2b; Drug: Tenofovir Alafenamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
HDV RNA level
Decline in HDV RNA ≥ 2 log10 IU/mL at Week 60
Measured: Week 60
ALT level
ALT normalization (ALT < upper limit of normal) at Week 60
Measured: Week 60
Secondary outcomes (6)
Undetectable HDV RNA
Undetectable HDV RNA (HDV RNA< low limit of quantifica-tion) at Week 60 and Week 84
Measured: Week 60 and Week 84
HBsAg level
Reduction in HBsAg ≥ 1 log10 IU/mL at Week 60 and Week 84
Measured: Week 60 and Week 84
Undetectable HBsAg
HBsAg loss at Week 60 and Week 84
Measured: Week 60 and Week 84
HBsAg and anti-HBs level
HBsAg seroconversion (HBsAg loss plus positive anti-HBs) at Week 60 and Week 84
Measured: Week 60 and Week 84
HDV RNA level
Decline in HDV RNA ≥ 2 log10 IU/mL at Week 84
Measured: Week 84
ALT level
ALT normalization (ALT < upper limit of normal) at Week 84
Measured: Week 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2022
- Study start24 Feb 2023 (estimated)
- Primary completion28 Feb 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis DStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- PharmaEssentia
- Responsible party
- Sponsor
- Investigators
- Pei-Jer Chen, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05467553
- Sponsor's protocol ID
- 202108021MIPD
- Other IDs
- P1101-HDV
- Status last verified
- Jul 2022
- First submitted
- 15 Jul 2022
- Last updated
- 29 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05467553
- Acronym / sponsor ID
- 202108021MIPD
- Conditions
- Hepatitis D
- Keywords
- Ropeginterferon alpha-2b, Hepatitis D, UDCA, TAF
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Collaborators
- PharmaEssentia
- Study start
- 24 Feb 2023 (estimated)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 20 Jul 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TAF and P1101 combination therapy with UDCA | Experimental | Drug: Ursodeoxycholic acid, Drug: Ropeginterferon alfa-2b, Drug: Tenofovir AlafenamideUrsodeoxycholic 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. |
| TAF and P1101 combination therapy without UDCA | Active comparator | Drug: Ropeginterferon alfa-2b, Drug: Tenofovir AlafenamideTAF 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. |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (21 listed)
- 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].
- History of significant alcohol or drug abuse within 6 months prior to the screening visit (alcohol consumption of more than 14 units of alcohol per week [1 Unit = 150 mL of wine, 360 mL of beer, or 45 mL of 40% alcohol]) or refusal to abstain from alcohol or illicit drugs throughout the study.
- Any history or presence of poorly controlled or clinically significant medical conditions that are not suitable to receive interferon-based treatment, at the discretion of the investigator: major psychiatric (including but not limited to those with severe depression, severe bi-polar disorder, schizophrenia, suicidal ideation or history of suicidal attempt), neurological, cardiovascular, pulmonary, hematologic, immunologic, autoimmune diseases, thyroid or other endocrine diseases, metabolic (e.g. diabetes mellitus with HbA1C > 8.0%) or other uncontrolled systemic disease, coagulation disorders or blood dyscrasias.
- Pregnant subject; female subject who are breast feeding or lactating; female subject or the spouse of male subject, with child-bearing potential who is unwilling or unable to practice adequate contraception, defined as vasectomy in men, tubal ligation in women, or use of condoms and spermicides, or birth control pills, or intrauterine devices throughout the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Ursodeoxycholic acidAlso: Uroso TabletsUrsodeoxycholic Acid 15 mg/kg PO QD for 60 weeks | Drug | TAF and P1101 combination therapy with UDCA |
| Ropeginterferon alfa-2bAlso: BESREMIP1101 450 µg SC Q2W add-on at treatment week 12 for 48 weeks | Drug | TAF and P1101 combination therapy with UDCA, TAF and P1101 combination therapy without UDCA |
| Tenofovir AlafenamideAlso: VemlidyTAF 25 mg PO QD for 60 weeks | Drug | TAF and P1101 combination therapy with UDCA, TAF and P1101 combination therapy without UDCA |
Primary outcome
HDV RNA level
Time frame: Week 60
Decline in HDV RNA ≥ 2 log10 IU/mL at Week 60
ALT level
Time frame: Week 60
ALT normalization (ALT < upper limit of normal) at Week 60
6 secondary outcomes
Undetectable HDV RNA
Time frame: Week 60 and Week 84
HBsAg level
Time frame: Week 60 and Week 84
Undetectable HBsAg
Time frame: Week 60 and Week 84
HBsAg and anti-HBs level
Time frame: Week 60 and Week 84
HDV RNA level
Time frame: Week 84
ALT level
Time frame: Week 84
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pei-Jer Chen principal investigator
National Taiwan University Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ursodeoxycholic acid, Ropeginterferon alfa-2b and Tenofovir Alafenamide in people with Hepatitis D, run by National Taiwan University Hospital at 2 sites in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 29 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pei-Jer Chen (886-2-23123456 ext. 67072, peijerchen@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HDV RNA level (time frame: Week 60). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2022.