The Safety and Efficacy of Sequential Treatment of Ropeginterferon Alfa-2b (P1101) and Anti-PD1 i… (NCT04638439) | Clinical Trial Compass
CompletedPhase 1
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
Taiwan20 participantsStarted 2022-08-17
Plain-language 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. To evaluate the rate of ALT normalization
Who can participate
Age range20 Years – 70 Years
SexALL
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Inclusion criteria
✓. 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;
✓. Be able to attend all scheduled visits and to comply with all study procedures;
✓. Patients with anti-HDV (+) can be enrolled;
Exclusion criteria
✕. 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;
What they're measuring
1
Safety: AE/SAE
Timeframe: Through study Follow-up Week 24 (up to 330 days)
2
Safety: clinically significant abnormalities
Timeframe: Through study Follow-up Week 24 (up to 330 days)
✕. 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;
✕. 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;