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Chronic Hepatitis B Virus InfectionNCT05494528

Comparing P1101 to Entecavir in Patients With HBeAg(-) Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy

A study testing Ropeginterferon alfa-2b and Entecavir in people with Chronic Hepatitis B Virus Infection, run by National Taiwan University Hospital at 5 sites in Taiwan.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is an open-label, multicenter, randomized, active control study, comparing P1101 monotherapy to entecavir monotherapy in patients with HBeAg-negative chronic hepatitis B under long-term nucleos(t)ide analogue therapy. Read more about this study

Who is it for?
Ages 20 to 75 years
Conditions the study is for
Chronic Hepatitis B Virus Infection
What is being tested?
Ropeginterferon alfa-2b and Entecavir
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
5 sitesTaiwan
Study dates
4 May 2021to 30 Dec 2024
Phase
Interventional
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

  • Adults with age 20-75 years old; Subjects who are over 70 years of age must be in generally good health;
  • Confirmed diagnosis of chronic hepatitis B (CHB) virus infection: with positive HBsAg ≧ 6 months prior to the study entry;
  • Quantitative HBsAg level < 1,500 IU/ml at screening;
  • Confirmed HBeAg (-) at screening;
  • Stable disease: ALT < 3 x upper limit of normal (ULN), total bilirubin < 1.5 × ULN (except in Gilbert syndrome) and direct bilirubin < ULN at screening, serum HBV DNA < 50 IU/mL for ≧ 1 year prior to study entry;
  • Stable treatment with nucleos(t)ide regimen (adefovir, entecavir, tenofovir or one of the following combinations: entecavir/adefovir or entecavir/tenofovir) for at least 2 years prior to study entry;
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  • Interferon treatment naïve;
  • Normal fundoscopic examination by ophthalmologist at screening; defined as no significant or major fundoscopic findings including but not limited to retinal exudates, hemorrhage, detachment, neovascularization, papilloedema, optic atrophy, microaneurysms and macular changes;
  • Be able to attend all scheduled visits and to comply with all study procedures;
  • Be able to provide written informed consent.

Who cannot join

  • HBeAg-positive chronic hepatitis B;
  • Documented history of drug resistance to any nucleoside/ nucleotide analogue;
  • History of treatment with lamivudine or telbivudine prior to the study entry;
  • Clinically significant abnormalities, other than HBV infection, based upon the results of a medical history, physical examination, vital signs, and a 12-lead electrocardiogram (ECG) at screening as determined by the investigator;
  • Other form of significant chronic liver disease apart from chronic hepatitis B infection; Severe steatohepatitis by ultrasound or other examinations at the discretion of investigators;
  • Liver cirrhosis;
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  • Known positive for anti-HIV;
  • Positive for anti-hepatitis C virus(HCV), Subject could be enrolled if no HCV RNA detected within 1 year；
  • Co-infection with hepatitis D;
  • One of clinically significant abnormal laboratory test result at screening: white blood cell (WBC) < 3,000/mm^3, absolute neutrophil count (ANC) < 1500/mm^3, Hgb < 10g/dL, platelet < 90,000/mm^3, estimated Glomerular filtration rate < 60 mL/min;
  • History of significant alcohol or illicit drug abuse within six months prior to the screening visit (alcohol consumption of more than fourteen 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 illicit drugs and minimize alcohol consumption throughout the study;
  • History of severe allergic or hypersensitivity reactions (e.g bronchospasm, angioedema), asthma, or anaphylaxis
  • Therapy with any systemic anti-viral treatment (except for treatment for HBV), anti-neoplastic, immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) and immunosuppressants within 1 month (3 months for those with long elimination half-lives) prior to the first dose of study drug;
  • Use of an investigational drug within the last 4 weeks;
  • 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 bipolar disorder, schizophrenia, suicidal ideation or history of suicidal attempt),neurological, cardiovascular (e.g. uncontrolled hypertension), pulmonary (including but not limited to chronic obstructive lung disease), hematological, immunologic, endocrine, metabolic (e.g. diabetes mellitus with HbA1C > 8.0%), autoimmune disease, thyroid or other uncontrolled systemic disease, coagulation disorders or blood dyscrasias;
  • 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;
  • History of solid organ transplantation;
  • History of malignancy diagnosed or treated within 5 years prior to screening (except for recent localized treatment of squamous or noninvasive 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 the 3 months prior to screening;
  • Pregnant subjects. Female subjects or the spouse of male subjects, with child-bearing potential who are 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 from 4 weeks prior to Day 1 until 90 days after the last dose of study drug.

Trial locations and contacts

5 sites in 1 country.

Chun-Jen Liu contact

886-2-23123456 ext. 67503

cjliu@ntu.edu.tw

5 sites in 1 country

Taiwan5 sites, 5 recruiting

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

    Chia-Yen Dai

    Chia-Yen Dai

    Not yet recruiting

  • China Medical University Hospital

    Taichung

    Cheng-Yuan Peng

    Not yet recruiting

  • National Taiwan University Hospital

    Taipei

    Chun-Jen Liu

    Chun-Jen Liu

    Recruiting

  • Taipei Medical University Hospital

    Taipei

    Yi-Wen Huang

    Not yet recruiting

  • Taipei Veterans General Hospital

    Taipei

    Yi-Hsiang Huang

    Yi-Hsiang Huang

    Not yet recruiting

Other trials in Taiwan

About this study

Official title: An, Open-label, Multicenter, Randomized, Active Control Study, Comparing P1101 Monotherapy to Entecavir Monotherapy in Patients With HBeAg-negative Chronic Hepatitis B Under Long-term Nucleos(t)Ide Analogue Therapy

This is an open-label, multicenter, randomized, active control study, comparing P1101 monotherapy to entecavir monotherapy in patients with HBeAg-negative chronic hepatitis B under long-term nucleos(t)ide analogue therapy.

Read the detailed description

Eligible patients will be randomized in a 2:1 ratio (P1101 monotherapy vs. Entecavir monotherapy) using a computer-generated permuted block randomization scheme.

Subjects will be treated with 450 µg of P1101 every two weeks or with 0.5 mg of Entecavir monotherapy once per day. Primary endpoint will be evaluated at week 48. Subjects will receive treatment with a total duration of 72 weeks. The follow-up (treatment-free) period is 24 weeks following completion of treatment. Switch from the other nucleos(t)ide analogue therapy to entecavir will occur at week 0 (Randomization), while the dose of Entecavir will be 0.5 mg.

Being tested
Ropeginterferon alfa-2b, Entecavir
Keywords
Ropeginterferon alpha-2b, Hepatitis B, Entecavir, HBeAg-negative, Nucleoside Analogue Therapy
Medical subject headings
Hepatitis B, Chronic, Hepatitis B

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ropeginterferon alfa-2bDrug

    Also called P1101

    Ropeginterferon alfa-2b 450 µg subcutaneous injection every two weeks

  • EntecavirDrug

    Entecavir 0.5 mg once per day

Study groups in NCT05494528
Study groupRoleWhat they receive
Ropeginterferon alfa-2b monotherapyExperimentalSubjects will be treated with 450 µg of Ropeginterferon alfa-2b every two weeks
Receives: Drug: Ropeginterferon alfa-2b
Entecavir monotherapyActive comparatorSubjects will be treated with 0.5 mg of Entecavir monotherapy once per day
Receives: Drug: Entecavir

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Undetectable HBsAg

    HBsAg loss at week 48

    Measured: Week 48

Secondary outcomes (9)

  1. Undetectable HBsAg

    HBsAg loss at weeks 72 and 96

    Measured: weeks 72 and 96

  2. HBsAg level

    HBsAg reduction > 1 log from baseline to weeks 12, 24, 48, 72 and 96

    Measured: weeks 12, 24, 48, 72 and 96

  3. HBsAg and anti-HBs level

    HBsAg seroconversion at weeks 48, 72 and 96

    Measured: weeks 48, 72 and 96

  4. HBsAg level

    Mean HBsAg decline from baseline to weeks 12, 24, 48, 72, and 96

    Measured: weeks 12, 24, 48, 72, and 96

  5. Reappearance of HBsAg

    HBsAg seroreversion at weeks 72 and 96

    Measured: weeks 72 and 96

  6. HBV DNA level

    Percentage of subjects with HBV DNA > 2,000 IU/ml at week 96

    Measured: week 96

  7. HBV DNA and alanine aminotransferase (ALT) level

    Percentage of subjects with HBV DNA > 2,000 IU/ml and ALT > 2x ULN at week 96

    Measured: week 96

  8. Sustained suppression of HBV DNA

    Sustained suppression of HBV DNA less than the lower limit of qualification at week 96.

    Measured: week 96

  9. HBeAg level

    To compare the proportion of HBeAg seroreversion and seroconversion at weeks 72 and 96 across treatment arms.

    Measured: weeks 72 and 96

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2022
  2. Study start4 May 2021
  3. Primary completion30 Dec 2023 (estimated)
  4. Study completion30 Dec 2024 (estimated)

Resources

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 N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
90 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05494528
Sponsor's protocol ID
202003098MIPD
Other IDs
A18-I02
Status last verified
Mar 2022
First submitted
8 Aug 2022
Last updated
27 Dec 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Ropeginterferon alfa-2b and Entecavir in people with Chronic Hepatitis B Virus Infection, run by National Taiwan University Hospital 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 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 27 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 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.

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 Chun-Jen Liu (886-2-23123456 ext. 67503, cjliu@ntu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Undetectable HBsAg (time frame: Week 48). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05494528.

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 27 Dec 2022.

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