Clinical Trials List
Protocol NumberA18-I02
Active
2021-01-04 - 2025-12-31
Others
Not yet recruiting1
Recruiting5
ICD-10B18.1
Chronic viral hepatitis B without delta-agent
ICD-9070.32
Viral hepatitis B without mention of hepatic coma, chronic, without mention of hepatitis delta
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
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Trial Applicant
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Sponsor
National Taiwan University Hospital
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Trial scale
Taiwan Multiple Center
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Update
2026/02/01
Investigators and Locations
Co-Principal Investigator
- 陳柏岳 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chien-Wei Su Digestive System Department
- I-Cheng Lee Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wei-Fan Hsu Digestive System Department
- Hung-Yao Chen Digestive System Department
- Tsung-Yu Tsai Digestive System Department
- Hung-Wei Wang Digestive System Department
- Hsueh-Chou Lai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Jia-Horng Kao Digestive System Department
- 曾岱宗 Digestive System Department
- 楊宏志 Digestive System Department
- PEI-JER CHEN Digestive System Department
- 洪俊銘 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Ming-Lung Yu Digestive System Department
- 梁博程 Digestive System Department
- Wan-Long Chuang Digestive System Department
- 黃駿逸 Digestive System Department
- Chung-Feng Huang Digestive System Department
- Jee-Fu Huang Digestive System Department
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Chun-Chao Chang Digestive System Department
- Tiong Cheng Digestive System Department
- 黃奕文 Digestive System Department
- 劉正典 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Not yet recruiting
Condition/Disease
chronic hepatitis B virus infection
Objectives
Primary objective:
To compare the effectof P1101monotherapyas compare entecavir monotherapy onHBsAg loss at treatment week 48.Secondary objectives:
To compare the proportion ofHBsAg loss at weeks 72 and 96between the two groups.
To compare the proportion ofHBsAg reduction > 1 log from baseline toweeks12, 24, 48, 72and 96between the two groups.
To compare the proportion ofHBsAg seroconversion at weeks48, 72and 96between the two groups.
To compare mean HBsAg decline from baseline toweeks 12, 24, 48, 72and 96between the two groups.
To compare the proportionof HBsAg seroreversion, defined as reappearance of measurable HBsAg in patients who previously lost HBsAg at weeks 72 and 96between the two groups.
To compare the proportionof subjects withHBV DNA > 2,000 IU/ml at week 96between the two groups.
To compare the proportionof subjects withHBV DNA > 2,000 IU/ml andALT > 2x ULN at week 96between the two groups.
To compare sustained suppression of HBV DNA less than LLOQ at week 96 between the two groups.
To compare the proportion of HBeAgseroreversion and seroconversion at weeks 72 and96 between thetwo groups.
Tocompare the incidence of clinically relevant liver-related complications (HCC andliver cirrhosis) between the two groups.
To compare safety and tolerability between the two groups, and analyze adverse events and laboratory data.
Test Drug
Ropeginterferon alfa-2b (P1101)
Active Ingredient
Ropeginterferon alfa-2b
Dosage Form
IVT
Dosage
500
Endpoints
Primary endpoint
HBsAg loss at Week 48(presented as a binary endpoint experienced HBsAg loss or not)
Secondary endpoints
Secondary endpoints for the study include the following:
•HBsAgloss at weeks 72 and 96•HBsAg reduction > 1 log from baseline to weeks12, 24, 48, 72and 96
•HBsAg seroconversion at week 48, 72and 96
•Mean HBsAg decline from baseline to weeks 12, 24, 48,72and 96
•HBsAg seroreversion atweek 72 and 96
•Percentage of subjects with HBV DNA > 2,000 IU/ml at week 96
•Percentage of subjects with HBV DNA > 2,000 IU/ml and ALT > 2x ULN at week 96
•Sustained suppression of HBV DNA less than LLOQ at week 96
•The incidence of clinically relevant liver-related complications (HCC and liver cirrhosis) across treatment arms
•To compare the proportion of HBeAg seroreversion and seroconversion at weeks 72 and 96across treatment arms
•Adverse events and clinically significant laboratory abnormalities in each treatment arm
HBsAg loss at Week 48(presented as a binary endpoint experienced HBsAg loss or not)
Secondary endpoints
Secondary endpoints for the study include the following:
•HBsAgloss at weeks 72 and 96•HBsAg reduction > 1 log from baseline to weeks12, 24, 48, 72and 96
•HBsAg seroconversion at week 48, 72and 96
•Mean HBsAg decline from baseline to weeks 12, 24, 48,72and 96
•HBsAg seroreversion atweek 72 and 96
•Percentage of subjects with HBV DNA > 2,000 IU/ml at week 96
•Percentage of subjects with HBV DNA > 2,000 IU/ml and ALT > 2x ULN at week 96
•Sustained suppression of HBV DNA less than LLOQ at week 96
•The incidence of clinically relevant liver-related complications (HCC and liver cirrhosis) across treatment arms
•To compare the proportion of HBeAg seroreversion and seroconversion at weeks 72 and 96across treatment arms
•Adverse events and clinically significant laboratory abnormalities in each treatment arm
Inclution Criteria
Inclusion Criteria
1.Adults between 20-75years old;Subjects who are over 70 years of age must be in generally good health
2.Confirmed diagnosis of chronic hepatitis B (CHB) virus infection: with positive HBsAg 6 months prior to the study entry;3.Quantitative HBsAglevel < 1,500IU/ml at screening;4.Confirmed HBeAg (-)at screening;5.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;6.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; 7.Interferon treatment naïve;8.Be able to attend all scheduled visits and to comply with all study procedures;9.Be able to provide written informed consent.
1.Adults between 20-75years old;Subjects who are over 70 years of age must be in generally good health
2.Confirmed diagnosis of chronic hepatitis B (CHB) virus infection: with positive HBsAg 6 months prior to the study entry;3.Quantitative HBsAglevel < 1,500IU/ml at screening;4.Confirmed HBeAg (-)at screening;5.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;6.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; 7.Interferon treatment naïve;8.Be able to attend all scheduled visits and to comply with all study procedures;9.Be able to provide written informed consent.
Exclusion Criteria
ExclusionCriteria
Any of the following is cause for exclusion from the study:
1.HBeAg-positive chronic hepatitis B;
2.Documented history of drug resistance to any nucleoside/nucleostide analogue;
3.History of treatment with lamivudine or telbivudine prior to the study entry;
4.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;
5.Other form of significant chronic liver disease apart from chronic hepatitis B infection; significant steatohepatitisby ultrasound or other examinations at the discretion of investigators;
6.Liver cirrhosis;
7.Positive for anti-HIV;
8.Positive for anti-HCV;
9.Co-infection with hepatitis D;
10.One of clinically significant abnormal laboratory test result at screening: WBC < 3,000/mm3, ANC < 1,500/mm3, Hgb < 10g/dL, platelet <90,000/mm3, e-GFR < 60 mL/min ;
11.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 consumptionthroughout the study;
12.History of severe allergic or hypersensitivity reactions (e.g bronchospasm,angioedema), asthma,oranaphylaxis;
13.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;
14.Use of an investigational drug within the last 4 weeks;
15.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;
16.A depot injection or an implant of any drug within 3 months prior to administration of study medication, other than contraceptionor hyaluronic acid injections in joints for osteoarthritis;
17.History of solid organ transplantation;
18.History of malignancy diagnosed or treated within 5 years prior to screening (except for recent 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
19.History of opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia);
20.Seriouslocalized infection (e.g., cellulitis, abscess) or systemic and life-threateninginfection (e.g., septicemia) within the 3months prior to screening;
21.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;
Any of the following is cause for exclusion from the study:
1.HBeAg-positive chronic hepatitis B;
2.Documented history of drug resistance to any nucleoside/nucleostide analogue;
3.History of treatment with lamivudine or telbivudine prior to the study entry;
4.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;
5.Other form of significant chronic liver disease apart from chronic hepatitis B infection; significant steatohepatitisby ultrasound or other examinations at the discretion of investigators;
6.Liver cirrhosis;
7.Positive for anti-HIV;
8.Positive for anti-HCV;
9.Co-infection with hepatitis D;
10.One of clinically significant abnormal laboratory test result at screening: WBC < 3,000/mm3, ANC < 1,500/mm3, Hgb < 10g/dL, platelet <90,000/mm3, e-GFR < 60 mL/min ;
11.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 consumptionthroughout the study;
12.History of severe allergic or hypersensitivity reactions (e.g bronchospasm,angioedema), asthma,oranaphylaxis;
13.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;
14.Use of an investigational drug within the last 4 weeks;
15.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;
16.A depot injection or an implant of any drug within 3 months prior to administration of study medication, other than contraceptionor hyaluronic acid injections in joints for osteoarthritis;
17.History of solid organ transplantation;
18.History of malignancy diagnosed or treated within 5 years prior to screening (except for recent 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
19.History of opportunistic infection (e.g., invasive candidiasis or pneumocystis pneumonia);
20.Seriouslocalized infection (e.g., cellulitis, abscess) or systemic and life-threateninginfection (e.g., septicemia) within the 3months prior to screening;
21.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;
The Estimated Number of Participants
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Taiwan
90 participants
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Global
90 participants
