A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B
- Conditions
- Hepatitis B, Chronic
- Registration Number
- NCT04225715
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 281
Inclusion Criteria:<br><br> - Body mass index between 18 and 32 kg/m2 inclusive.<br><br> - Participants with Chronic Hepatitis B (CHB) infection (HBsAg positive for >=6<br> months) who are on established NUC (entecavir or tenofovir alafenamide/disoproxil<br> fumarate) monotherapy for >=12 months, having received the same NUC therapy for >=3<br> months prior to screening.<br><br> - HBV DNA below the lower LLOQ or < 20 IU/mL for > 6 months prior to screening and<br> confirmed at screening.<br><br> - Alanine transaminase (ALT) <=1.5 x upper limit of normal (ULN) for > 6 months prior<br> to screening and confirmed at screening.<br><br> - Female Participants: Eligible to participate if she is not pregnant, not<br> breastfeeding and agrees to remain abstinent (refrain from heterosexual intercourse)<br> or use highly effective contraceptive methods.<br><br> - Male Participants: During the treatment period and for at least 6 months after the<br> final dose of study treatment, agrees to remain abstinent (refrain from heterosexual<br> intercourse), use contraceptive measures and refrain from donating sperm.<br><br>Exclusion Criteria:<br><br> - Pregnant or lactating women.<br><br> - Co-infection with other pathogens such as Hepatitis A, C, D and E or Human<br> Immunodeficiency Virus (HIV).<br><br> - History of cirrhosis or current evidence of significant liver fibrosis or cirrhosis<br> or decompensated liver disease.<br><br> - History of or suspicion of Hepatocellular Carcinoma (HCC).<br><br> - Thyroid disease poorly controlled on prescribed medications or clinically relevant<br> abnormal thyroid function tests.<br><br> - Clinically significant disease other than CHB that, in the opinion of the<br> Investigator, makes the participant unsuitable for the study.<br><br> - Pre-existing cardiac disease that in the opinion of the investigator would increase<br> the risk for the participant to take part in the study.<br><br> - History of alcohol abuse and/or drug abuse within one year of randomization.<br><br> - History of having received (in the last 6 months) or currently receiving any<br> systemic antineoplastic (including radiation) or immunosuppressive (including<br> biologic immunosuppressors) or immune modulating treatment.<br><br> - Currently taking, or have received within 3 months of Day 1, systemic<br> corticosteroids.<br><br> - Electrocardiogram (ECG) with clinically significant abnormalities.<br><br> - Previous treatment with an investigational agent for Hepatitis B (HBV) within 6<br> months prior to screening.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percentage of Participants with Hepatitis B Surface Antigen (HBsAg) loss at 24 weeks post-EOT (End Of Treatment)
- Secondary Outcome Measures
Name Time Method Percentage of Participants with HBsAg loss;Percentage of Participants with HBsAg seroconversion;Percentage of Participants with Hepatitis B Early Antigen (HBeAg) loss (baseline HBeAg-positive participants).;Percentage of Participants with HBeAg seroconversion (baseline HBeAgpositive participants);Percentage of Participants with HBV DNA < lower limit of quantification (LLOQ), <200 IU/mL and <2,000 IU/mL;Change from baseline in quantitative HBsAg, anti-HBs, HBeAg, anti-HBe, anti-HBc, HBcrAg, HBV RNA, and HBV DNA levels over time (IU/mL);Plasma Pharmacokinetics (PK) (TLR7) (IU/mL);Plasma PK (CpAM) (IU/mL);Plasma PK (NUC) (IU/mL);Plasma PK (siRNA) (IU/mL);Serum PK (PEG-IFN) (IU/mL);Percentage of Participants with Adverse Events (AEs);Percentage of Participants with Anti-siRNA Antibodies;Percentage of Participants with Anti-PEG-IFN Antibodies;Plasma PK PD-L1 LNA;Percentage of Participants with Anti PD-L1 LNA Antibodies