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

NCT05494528 | Unknown

• 2 other identifiers: 202003098MIPDA18-I02
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

Chronic Hepatitis B Virus Infection

Keywords

Ropeginterferon alpha-2b; Hepatitis B; Entecavir; HBeAg-negative; Nucleoside Analogue Therapy

Outcome Measures

Primary Outcomes (1)

• Undetectable HBsAg

  HBsAg loss at week 48

  Week 48

Secondary Outcomes (9)

• Undetectable HBsAg

  weeks 72 and 96

• HBsAg level

  weeks 12, 24, 48, 72 and 96

• HBsAg and anti-HBs level

  weeks 48, 72 and 96

• HBsAg level

  weeks 12, 24, 48, 72, and 96

• Reappearance of HBsAg

  weeks 72 and 96

Study Arms (2)

Ropeginterferon alfa-2b monotherapy

EXPERIMENTAL

Subjects will be treated with 450 µg of Ropeginterferon alfa-2b every two weeks

Drug: Ropeginterferon alfa-2b

Entecavir monotherapy

ACTIVE COMPARATOR

Subjects will be treated with 0.5 mg of Entecavir monotherapy once per day

Drug: Entecavir

Interventions

Ropeginterferon alfa-2b DRUG

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

Also known as: P1101

Ropeginterferon alfa-2b monotherapy

Entecavir DRUG

Entecavir 0.5 mg once per day

Entecavir monotherapy

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• National Taiwan University Hospital: lead
• PharmaEssentia: collaborator

Study Sites (5)

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

NOT YET RECRUITING

China Medical University Hospital

Taichung, Taiwan

NOT YET RECRUITING

National Taiwan University Hospital

Taipei, Taiwan

RECRUITING

Taipei Medical University Hospital

Taipei, Taiwan

NOT YET RECRUITING

Taipei Veterans General Hospital

Taipei, Taiwan

NOT YET RECRUITING

MeSH Terms

Conditions

Hepatitis B, Chronic; Hepatitis B

Interventions

entecavir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Chun-Jen Liu

  National Taiwan University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Chun-Jen Liu

CONTACT

886-2-23123456; cjliu@ntu.edu.tw

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2022
• First Posted: August 10, 2022
• Study Start: May 4, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 30, 2024
• Last Updated: December 27, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (5)