| Eligibility |
Inclusion Criteria:
1. Positive for HBsAg for at least 6 months, either HBeAg (+) or HBeAg (-), and ALT =ULN
to = 10X ULN at screening;
2. Interferon naïve;
3. Quantitative HBsAg Level < 1,500 IU/mL at screening; Undetectable HBV DNA (either
under NUC treatment or not)
4. 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;
5. 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;
6. ECG without clinically significant abnormalities before study entry;
7. Be able to attend all scheduled visits and to comply with all study procedures;
8. Patients with anti-HDV (+) can be enrolled;
9. Patients with fibrosis stage < F4 can be enrolled;
10. Willing to provide written informed consent;
Exclusion Criteria:
1. Clinically significant illness or surgery that might interfere with study
participation;
2. Clinically significant vital sign abnormalities or fever [body temperature >38?]);
3. 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;
4. 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;
5. 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;
6. 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;
7. 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;
8. 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;
9. Body organ transplant or taking immunosuppressant;
10. Use investigational drug of other clinical trials within 4 weeks prior to the first
dose of the study drug;
11. 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);
12. History of opportunistic infection (e.g., invasive candidiasis or pneumocystis
pneumonia);
13. Serious localized infection (e.g., cellulitis, abscess) or systemic and
life-threatening infection (e.g., septicemia) within 3 months prior to screening;
14. Clinically significant medical conditions known to interfere absorption, distribution,
metabolism or excretion of the study drugs;
15. 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;
16. Significant steatohepatitis by ultrasound or other examination at the discretion of
investigator;
17. Other form of significant chronic liver diseases, except those mentioned above (e.g.
HBV, HDV);
18. Significant or major fundoscopic findings at screening including but not limited to
retinal exudates, hemorrhage, detachment, neovascularization, papilledema, optic
atrophy, microaneurysms and macular changes;
19. Positive for anti-HIV or anti-HCV;
20. 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;
21. 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;
22. Patients under monotherapy by telbivudine or any other combination therapy with
telbivudine.
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