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

  • STATUS
    Recruiting
  • End date
    Nov 30, 2024
  • participants needed
    275
  • sponsor
    Hoffmann-La Roche
Updated on 14 September 2022
body mass index
combination therapy
tenofovir
fumarate
cirrhosis
entecavir
hepatitis b antigen
fibrosis
chronic hepatitis

Summary

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.

Details
Condition Hepatitis B, Chronic
Treatment Peg-IFN, Nucleos(t)ide (NUC), CpAM (RO7049389), TLR7 (RO7020531), siRNA (RO7445482), PD-L1 LNA (RO7191863)
Clinical Study IdentifierNCT04225715
SponsorHoffmann-La Roche
Last Modified on14 September 2022

Eligibility

Yes No Not Sure

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

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
Electrocardiogram (ECG) with clinically significant abnormalities
History of alcohol abuse and/or drug abuse within one year of randomization
Previous treatment with an investigational agent for Hepatitis B (HBV) within 6 months prior to screening
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
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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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