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A Trial To Evaluate The Efficacy And Safety Of Multiple Combination Therapies In Participants With Chronic Hepatitis B
Infectious Diseases Chronic Hepatitis B Hepatitis B Virus
Basic Details
Study 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.
Eligibility 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.
- 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 source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
Results Disclaimer
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Study results
LPS WV41073 PIRANGA Final Results February 2024 English
(PDF, 2.1 MB)
LPS WV41073 PIRANGA Final Results March 2024 China Chinese
(PDF, 1.0 MB)
LPS WV41073 PIRANGA Final Results March 2024 Taiwan Chinese
(PDF, 0.6 MB)
LPS WV41073 PIRANGA Final Results February 2024 South Korea Korean
(PDF, 0.4 MB)
LPS WV41073 PIRANGA Final Results February 2024 Spain Spanish
(PDF, 0.8 MB)
LPS WV41073 PIRANGA Final Results February 2024 Thailand Thai
(PDF, 0.4 MB)
LPS WV41073 PIRANGA Final Results September 2024 Chile Spanish
(PDF, 0.9 MB)
LPS WV41073 PIRANGA Final Results September 2024 China Chinese
(PDF, 2.6 MB)
LPS WV41073 PIRANGA Final Results September 2024 English
(PDF, 6.1 MB)
LPS WV41073 PIRANGA Final Results September 2024 France French
(PDF, 1.0 MB)
LPS WV41073 PIRANGA Final Results September 2024 South Korea Korean
(PDF, 0.8 MB)
LPS WV41073 PIRANGA Final Results September 2024 Spain Spanish
(PDF, 0.9 MB)
LPS WV41073 PIRANGA Final Results September 2024 Taiwan Chinese
(PDF, 1.3 MB)
LPS WV41073 PIRANGA Final Results September 2024 Thailand Thai
(PDF, 0.7 MB)
LPS WV41073 PIRANGA Final Results February 2025 English
(PDF, 3.4 MB)
LPS WV41073 PIRANGA Final Results February 2025 Romania Romanian
(PDF, 0.4 MB)
LPS WV41073 PIRANGA Final Results February 2025 Spain Spanish
(PDF, 0.3 MB)
LPS WV41073 PIRANGA Final Results February 2025 Bulgaria Bulgarian
(PDF, 0.4 MB)
LPS WV41073 PIRANGA Final Results February 2025 Taiwan Chinese
(PDF, 1.8 MB)
LPS WV41073 PIRANGA Final Results February 2025 Thailand Thai
(PDF, 1.6 MB)
LPS WV41073 PIRANGA Final Results February 2025 South Korea Korean
(PDF, 1.6 MB)
LPS WV41073 PIRANGA Final Results February 2025 France French
(PDF, 0.3 MB)
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For the latest version of this information please go to www.forpatients.roche.com