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NCT Number: NCT06650852

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)

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.

Recruiting

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site 86001, Beijing, Beijing Municipality, China

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

BRII-179

Biological

BRII-179 will be given via intramuscular injection

BRII-835 (VIR-2218)

Drug

BRII-835 will be given via subcutaneous injection

Other names: elebsiran

PEG-IFNα

Biological

PEG-IFNα will be given via subcutaneous injection

Other names: Pegylated interferon alfa

Placebo of BRII-179

Drug

Placebo of BRII-179 will be given via intramuscular injection

Placebo of BRII-835

Drug

Placebo of BRII-835 will be given via subcutaneous injection

Primary outcomes

  1. The percentage of participants achieving HBsAg seroclearance.

    Time frame: Up to 48 weeks

  2. Percentage of participants with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).

    Time frame: Up to 96 weeks

Secondary outcomes

  1. Percentage of participants achieving HBsAg seroconversion.

    Time frame: Up to 48 weeks

  2. Percentage of participants achieving HBsAg seroclearance.

    Time frame: Up to 72 weeks

  3. Percentage of participants achieving HBsAg seroconversion.

    Time frame: Up to 72 weeks

  4. Percentage of participants achieving functional cure.

    Time frame: Up to 96 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Research, Brii Biosciences

CONTACT

[email protected]

+86 10 6299 8808

Sponsors and collaborators

Lead sponsor

Brii Biosciences Limited

Industry

Registry information

Official study title

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)

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Oct 21, 2024
Registry last updated
May 23, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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