Chronic Hepatitis B InfectionPhase 1NCT04638439
The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
A Phase 1 study testing P1101 + Nivolumab + Entecavir in people with Chronic Hepatitis B Infection and Chronic Hepatitis D Infection, run by PharmaEssentia at 5 sites in Taiwan.
Trial summary
Primary objective: To evaluate the safety and tolerability of sequential administration of P1101 and anti-PD1 in patient with chronic hepatitis B or D infection Secondary objectives: 1. To explore HBsAg loss and kinetics during the study period 2. To assess the anti-viral effect during the study period 3. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Chronic Hepatitis B Infection, Chronic Hepatitis D Infection
- What is being tested?
- P1101 + Nivolumab + Entecavir
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 5 sitesTaiwan
- Study dates
- 17 Aug 2022to 8 Apr 2026
- Phase
- Phase 1
- 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 70 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 ALT ≤ 10X ULN at screening;
- Interferon naïve;
- Quantitative HBsAg Level < 5,000 IU/mL at screening; HBV DNA < 2,000 IU/mL (patients are either under NUC treatment or not);
- Adults ≥20 years of age; patients who are over 70 years of age must be in generally good health depending upon the Investigator's judgment;
- 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-HDV (+) can be enrolled;
- Patients with fibrosis stage < F3 can be enrolled;
- Willing to provide written informed consent;
Who cannot join
- Clinically significant illness or surgery that might interfere with study participation;
- Clinically significant vital sign abnormalities or fever [body temperature >38℃]);
- 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 (i.e. uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina) or recent stroke or myocardial infarction), 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 patient, female patient or the spouse of male patient, 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 (P1101), bronchospasm, angioedema, asthma, or anaphylaxis;
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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 investigational drug of other clinical trials 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);
- 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 (e.g. HBV, HDV);
- Significant or major fundoscopic findings at screening including but not limited to retinal exudates, hemorrhage, detachment, neovascularization, papilledema, optic atrophy, microaneurysms and macular changes;
- Positive for anti-HIV or anti-HCV;
- Prior therapy with anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, anti-CTLA-4 antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathway;
- Any contraindication to receiving anti-PD-1 antibody (e.g. active or a history of life-threatening autoimmune conditions, corticosteroids treatment required) or hypersensitivity to the constituents of anti-PD-1 antibody;
- Patients under monotherapy by telbivudine or any other combination therapy with telbivudine.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Taiwan5 sites
Chia-Yi Christian Hospital
Chiayi City
National Taiwan University Hospital
Taipei
Taipei Medical University Hospital
Taipei
Taipei Veterans General Hospital
Taipei
Chang Gung Memorial Hospital, Linkou
Taoyuan City
About this study
Official title: A Phase Ib, Open Label Study to Assess the Safety and Efficacy of Sequential Administration of P1101 and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
Primary objective:
To evaluate the safety and tolerability of sequential administration of P1101 and anti-PD1 in patient with chronic hepatitis B or D infection
Secondary objectives:
- To explore HBsAg loss and kinetics during the study period
- To assess the anti-viral effect during the study period
- To evaluate the rate of ALT normalization
Read the detailed description
There are 20 scheduled visits (screening, treatment weeks \& follow-up weeks) for patients which include screening visit, TW0 (baseline), TW2, TW4, TW6, TW8, TW10, TW12, TW13, TW15, TW17, TW19, TW21, TW23 (EOT), FW4, FW8, FW12, FW16, FW20 and FW24.
- Being tested
- P1101 + Nivolumab + Entecavir
- Keywords
- P1101, Anti-PD1, HBV, HDV
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
P1101 + Nivolumab + EntecavirDrug
Also called P1101 (Ropeginterferon alfa-2b) + Nivolumab + Entecavir
P1101 (Ropeginterferon alfa-2b) 450 µg subcutaneously (SC) Q2W for 6 doses (12 weeks), followed by 0.3 mg/kg Nivolumab for 6 doses (12 weeks), with a follow up of 24 weeks. All patients will also receive Entecavir 0.5 mg QD from Day 1 to Follow-up 24.
| Study group | Role | What they receive |
|---|---|---|
| P1101 + Nivolumab + Entecavir | Experimental | Not described Receives: Drug: P1101 + Nivolumab + Entecavir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: AE/SAE
Number of patients with adverse events, including SAEs
Measured: Through study Follow-up Week 24 (up to 330 days)
Safety: clinically significant abnormalities
Number of patients with clinically significant abnormalities, including vital sign, physical examination, electrocardiogram (ECG) and laboratory data
Measured: Through study Follow-up Week 24 (up to 330 days)
Secondary outcomes (7)
Subjects with HBsAg loss
The percentage of subjects with HBsAg loss at treatment week 12, 23 and follow up week 12, 24 in the treatment group
Measured: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Subjects with HBsAg reduction from baseline
The percentage of subjects with HBsAg reduction from baseline at treatment week 12, 23 and follow up week 12, 24 in the treatment group
Measured: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Subjects with HBsAg seroconversion
The percentage of subjects with HBsAg seroconversion at treatment week 12, 23 and follow up week 12, 24 in the treatment group
Measured: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Subjects with undetectable HBV DNA
The percentage of subjects with undetectable HBV DNA at treatment week 12, 23 and follow up week 12, 24 in the treatment group
Measured: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Subjects with ≥ 2 log10 decline from baseline in HDV RNA
The percentage of subjects with ≥ 2 log10 decline from baseline in HDV RNA at treatment week 12, 23 and follow up week 12, 24 in the treatment group
Measured: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Subjects with undetectable HDV RNA
The percentage of subjects with undetectable HDV RNA at treatment week 12, 23 and follow up week 12, 24 in the treatment group
Measured: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Subjects with ALT normalization
The percentage of subjects with ALT normalization at treatment week 12, 23 and follow up week 12, 24 in the treatment group
Measured: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2020
- Study start17 Aug 2022
- Primary completion8 Apr 2026
- Study completion8 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis B InfectionStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- PharmaEssentia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04638439
- Sponsor's protocol ID
- A20-101
- Status last verified
- Jun 2026
- First submitted
- 6 Nov 2020
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- 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 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Open Label Study to Assess the Safety and Efficacy of Sequential Administration of P1101 and Anti-PD1 in Interferon-Naive Adults With Chronic Hepatitis B or D Infection
- ClinicalTrials.gov ID
- NCT04638439
- Acronym / sponsor ID
- A20-101
- Keywords
- P1101, Anti-PD1, HBV, HDV
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- PharmaEssentiaIndustry (pharma, biotech, devices)
- Study start
- 17 Aug 2022 (actual)
- Primary completion
- 8 Apr 2026 (actual)
- Study completion
- 8 Apr 2026 (actual)
- First posted
- 20 Nov 2020 (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.
Primary objective:
To evaluate the safety and tolerability of sequential administration of P1101 and anti-PD1 in patient with chronic hepatitis B or D infection
Secondary objectives:
- To explore HBsAg loss and kinetics during the study period
- To assess the anti-viral effect during the study period
- To evaluate the rate of ALT normalization
Detailed description
There are 20 scheduled visits (screening, treatment weeks \& follow-up weeks) for patients which include screening visit, TW0 (baseline), TW2, TW4, TW6, TW8, TW10, TW12, TW13, TW15, TW17, TW19, TW21, TW23 (EOT), FW4, FW8, FW12, FW16, FW20 and FW24.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| P1101 + Nivolumab + Entecavir | Experimental | Drug: P1101 + Nivolumab + Entecavir |
Who may qualify
- Ages
- 20 to 70 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 ALT ≤ 10X ULN at screening;
- Interferon naïve;
- Quantitative HBsAg Level < 5,000 IU/mL at screening; HBV DNA < 2,000 IU/mL (patients are either under NUC treatment or not);
- Adults ≥20 years of age; patients who are over 70 years of age must be in generally good health depending upon the Investigator's judgment;
- 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 (22 listed)
- Clinically significant illness or surgery that might interfere with study participation;
- Clinically significant vital sign abnormalities or fever [body temperature >38℃]);
- 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 (i.e. uncontrolled hypertension, congestive heart failure (≥ NYHA class 2), serious cardiac arrhythmia, significant coronary artery stenosis, unstable angina) or recent stroke or myocardial infarction), 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 patient, female patient or the spouse of male patient, 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 |
|---|---|---|
| P1101 + Nivolumab + EntecavirAlso: P1101 (Ropeginterferon alfa-2b) + Nivolumab + EntecavirP1101 (Ropeginterferon alfa-2b) 450 µg subcutaneously (SC) Q2W for 6 doses (12 weeks), followed by 0.3 mg/kg Nivolumab for 6 doses (12 weeks), with a follow up of 24 weeks. All patients will also receive Entecavir 0.5 mg QD from Day 1 to Follow-up 24. | Drug | P1101 + Nivolumab + Entecavir |
Primary outcome
Safety: AE/SAE
Time frame: Through study Follow-up Week 24 (up to 330 days)
Number of patients with adverse events, including SAEs
Safety: clinically significant abnormalities
Time frame: Through study Follow-up Week 24 (up to 330 days)
Number of patients with clinically significant abnormalities, including vital sign, physical examination, electrocardiogram (ECG) and laboratory data
7 secondary outcomes
Subjects with HBsAg loss
Time frame: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Subjects with HBsAg reduction from baseline
Time frame: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Subjects with HBsAg seroconversion
Time frame: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Subjects with undetectable HBV DNA
Time frame: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Subjects with ≥ 2 log10 decline from baseline in HDV RNA
Time frame: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Subjects with undetectable HDV RNA
Time frame: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Subjects with ALT normalization
Time frame: Treatment Week 12, Treatment Week 23, Follow-up Week 12 and Follow-up Week 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing P1101 + Nivolumab + Entecavir in people with Chronic Hepatitis B Infection and Chronic Hepatitis D Infection, run by PharmaEssentia at 5 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 22 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: finished, as of the sponsor's last update on 10 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: AE/SAE (time frame: Through study Follow-up Week 24 (up to 330 days)). 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 10 Jun 2026.