A Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and PEG-IFNα in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

Официальное название

A Phase 2 Multicenter, Randomized, Double-Blind Study to Evaluate the Efficacy and Safety of Combination Therapy of BRII-179, BRII-835 and Pegylated Interferon Alpha (PEG-IFNα) in Participants With Chronic Hepatitis B Virus (HBV) Infection (ENHANCE)

Обзор

This Phase 2, randomized, double-blind study will evaluate the clinical efficacy and safety of the combination therapy of BRII-179, BRII-835, plus PEG-IFNα compared to PEG-IFNα in adult participants with chronic HBV infection without cirrhosis receiving neucloes(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Вмешательства

• Биопрепарат BRII-179
  BRII-179 will be given via intramuscular injection
• Препарат BRII-835 (VIR-2218)
  BRII-835 will be given via subcutaneous injection
• Биопрепарат PEG-IFNα
  PEG-IFNα will be given via subcutaneous injection
• Препарат Placebo of BRII-179
  Placebo of BRII-179 will be given via intramuscular injection
• Препарат Placebo of BRII-835
  Placebo of BRII-835 will be given via subcutaneous injection

Первичные конечные точки

• The percentage of participants achieving HBsAg seroclearance. [Срок оценки: Up to 48 weeks]
• Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs). [Срок оценки: Up to 96 weeks]

Вторичные конечные точки (4)

• Percentage of participants achieving HBsAg seroconversion. [Срок оценки: Up to 48 weeks]
• Percentage of participants achieving HBsAg seroclearance. [Срок оценки: Up to 72 weeks]
• Percentage of participants achieving HBsAg seroconversion. [Срок оценки: Up to 72 weeks]
• Percentage of participants achieving functional cure. [Срок оценки: Up to 96 weeks]

Критерии участия

Критерии включения

• Male or female aged 18-60 years.
• Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
• Chronic HBV infection for ≥ 6 months.
• On NRTI therapy with HBV DNA < LLOQ for ≥ 6 months.
• Serum ALT and AST ≤ ULN at screening visit.

Критерии исключения

• Any clinically significant chronic medical conditions other than chronic HBV infection that makes the participant unsuitable for participation in the study.
• Significant liver fibrosis or cirrhosis.
• History of clinically significant chronic liver disease from any cause other than chronic HBV infection.
• History of hepatic decompensation.
• Diagnosed or suspected hepatocellular carcinoma.
• Current or past history of infection with HIV, HCV or HDV.
• Any laboratory test abnormality that may contradict treatment with PEG-IFNα.
• Known history of immunological function impairment.
• History of intolerance to intramuscular or subcutaneous injection.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 14 центров

• Investigative Site 86001 — Пекин
• Investigative Site 86003 — Пекин
• Investigative Site 86004 — Пекин
• Investigative Site 86005 — Пекин
• Investigative Site 86016 — Пекин
• Investigative Site 86002 — Гуанчжоу
• Investigative Site 86013 — Гуанчжоу
• Investigative Site 86015 — Шэньчжэнь
• … и ещё 6 центров

Идентификаторы

NCT: NCT06650852 · BRII-179-835-003

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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