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Active (not recruiting) Phase 2 NCT05970289

Investigate the Efficacy and Safety of BRII-835 (VIR-2218) and PEG-IFNα Combination Therapy in Chronic HBV Patients

Phase 2 – studying effectiveness and dosage
Conditions: Chronic Hepatitis B Virus Infection

Sponsor: Brii Biosciences Limited

trial.available_in: БГ
Overview
This study will evaluate the efficacy and safety of PEG-IFNα alone or in combination with different dose levels of BRII-835 (VIR-2218) in participants with chronic hepatitis B virus (HBV) infection.
Who can participate
Inclusion Criteria: * Male or female aged 18-60. * Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2. * Chronic HBV infection for ≥ 6 months. * On NRTI therapy for at least 6 months. Exclusion Criteria: * Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation. * Significant liver fibrosis or cirrhosis. * History or evidence of drug or alcohol abuse. * History of intolerance to SC injection. * History of chronic liver disease from any cause other than chronic HBV infection. * History of hepatic decompensation. * Contraindications to the use of Peg-IFNα.
Locations 5
Australia (1)
Investigative Site 61001
Kingswood , New South Wales
China (1)
Investigative Site 86001
Beijing , Beijing Municipality
Singapore (1)
Investigative Site 65001
Singapore
South Korea (1)
Investigative Site 82002
Chuncheon , Chuncheon-si
Thailand (1)
Investigative Site 66003
Bangkok
Technical details
Status
Active (not recruiting)
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
60 Years
Healthy volunteers
No
Start date
22.08.2023
Completion date
01.02.2026
Registry ID
NCT05970289
Source
anzctr
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Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.