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Clinical Trials List

Protocol NumberWV41073

NCT Number(ClinicalTrials.gov Identfier)NCT04225715

2020-05-01 - 2025-03-31

Phase II

Recruiting6

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

A Phase II, Randomised, Adaptive, Open-Label Platform Trial To Evaluate Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B

Trial Applicant

COVANCE TAIWAN SERVICES LIMITED
Sponsor

F. Hoffmann-La Roche Ltd
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator 蘇維文無

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Sheng-Shun Yang 無

Taichung Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Cheng-Yuan Peng 無

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Jia-Horng Kao 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Wan-Long Chuang 無

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Ting-Tsung Chang 無

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Chronic Hepatitis B Infection

Objectives

This is a study designed to evaluate the safety, tolerability and efficacy of New Molecular Entity (NME) combination therapies in Chronic Hepatitis B (CHB) participants with preserved liver function and without significant fibrosis/cirrhosis. The platform design allows comparison of multiple NME combination therapies against a common control, and introduction of additional treatment arms at later study time points. Each arm will consist of a screening phase (up to 8 weeks), treatment phase (up to 48 weeks) and post-treatment follow-up phase (48 weeks). The safety and efficacy will be monitored throughout the study.

Test Drug

RO7049389、RO7020531、Vemlidy韋立得、Viread 惠立妥、Baraclude 貝樂克

Active Ingredient

entecavir
RO7020531
RO7049389
tenofovir alafenamide
tenofovir disoproxil fumarate

Dosage Form

Film-coated tablet
Film-coated tablet
Film-coated tablet
Tablet
Tablet

Dosage

200 mg
150 mg
25mg
300mg
0.5mg

Endpoints

Primary Outcome Measures :
Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) loss at 24 weeks post-EOT (End Of Treatment) [ Time Frame: Up to 72 weeks ]

Secondary Outcome Measures :
Percentage of Participants with HBsAg loss [ Time Frame: Up to 96 weeks ]
Percentage of Participants with HBsAg seroconversion [ Time Frame: Up to 96 weeks ]
Percentage of Participants with Hepatitis B Early Antigen (HBeAg) loss (baseline HBeAg-positive participants). [ Time Frame: Up to 96 weeks ]
Percentage of Participants with HBeAg seroconversion (baseline HBeAgpositive participants) [ Time Frame: Up to 96 weeks ]
Percentage of Participants with HBV DNA < lower limit of quantification (LLOQ), <200 IU/mL and <2,000 IU/mL [ Time Frame: Up to 96 weeks ]
Change from baseline in quantitative HBsAg, anti-HBs, HBeAg, anti-HBe, anti-HBc, HBcrAg, HBV RNA, and HBV DNA levels over time (IU/mL) [ Time Frame: Up to 96 weeks ]
Plasma Pharmacokinetics (PK) (TLR7) (IU/mL) [ Time Frame: Up to 48 weeks ]
Plasma PK (CpAM) (IU/mL) [ Time Frame: Up to 48 weeks ]
Plasma PK (NUC) (IU/mL) [ Time Frame: Up to 48 weeks ]
Plasma PK (siRNA) (IU/mL) [ Time Frame: Up to 48 weeks ]
Serum PK (PEG-IFN) (IU/mL) [ Time Frame: Up to 48 weeks ]
Percentage of Participants with Adverse Events (AEs) [ Time Frame: Up to 96 weeks ]
Percentage of Participants with Anti-siRNA Antibodies [ Time Frame: Up to 96 weeks ]
Percentage of Participants with Anti-PEG-IFN Antibodies [ Time Frame: Up to 96 weeks ]

Inclution Criteria

Inclusion Criteria:

Body mass index between 18 and 32 kg/m2 inclusive.
Participants with Chronic Hepatitis B (CHB) infection (HBsAg positive for >=6 months) who are on established NUC (entecavir or tenofovir alafenamide/disoproxil fumarate) monotherapy for >=12 months, having received the same NUC therapy for >=3 months prior to screening.
HBV DNA below the lower LLOQ or < 20 IU/mL for > 6 months prior to screening and confirmed at screening.
Alanine transaminase (ALT) <=1.5 x upper limit of normal (ULN) for > 6 months prior to screening and confirmed at screening.
Female Participants: Eligible to participate if she is not pregnant, not breastfeeding and agrees to remain abstinent (refrain from heterosexual intercourse) or use highly effective contraceptive methods.
Male Participants: During the treatment period and for at least 6 months after the final dose of study treatment, agrees to remain abstinent (refrain from heterosexual intercourse), use contraceptive measures and refrain from donating sperm.

Exclusion Criteria

Exclusion Criteria:

Pregnant or lactating women.
Co-infection with other pathogens such as Hepatitis A, C, D and E or Human Immunodeficiency Virus (HIV).
History of cirrhosis or current evidence of significant liver fibrosis or cirrhosis or decompensated liver disease.
History of or suspicion of Hepatocellular Carcinoma (HCC).
Thyroid disease poorly controlled on prescribed medications or clinically relevant abnormal thyroid function tests.
Clinically significant disease other than CHB that, in the opinion of the Investigator, makes the participant unsuitable for the study.
Pre-existing cardiac disease that in the opinion of the investigator would increase the risk for the participant to take part in the study.
History of alcohol abuse and/or drug abuse within one year of randomization.
History of having received (in the last 6 months) or currently receiving any systemic antineoplastic (including radiation) or immunosuppressive (including biologic immunosuppressors) or immune modulating treatment.
Currently taking, or have received within 3 months of Day 1, systemic corticosteroids.
Electrocardiogram (ECG) with clinically significant abnormalities.
Previous treatment with an investigational agent for Hepatitis B (HBV) within 6 months prior to screening.

The Estimated Number of Participants

Taiwan

50 participants
Global

200 participants