Active, Not Recruiting

NCT Number: NCT06491563

Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and PEG-IFNα Treating Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

This study will evaluate the efficacy and safety of the regimens containing BRII-179, BRII-835, and PEG-IFNα in adult participants with chronic hepatitis B virus (HBV) infection receiving nucleos(t)ide reverse transcriptase inhibitors (NRTIs) as background therapy.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

For Treatment of Chronic Hepatitis B Virus Infection

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigative Site 86004, Beijing, Beijing Municipality, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

1. Male or female aged 18-60 years.
2. Body mass index ≥ 18 kg/m2 and ≤ 32 kg/m2.
3. Chronic HBV infection for ≥ 6 months.
4. On NRTI therapy for ≥ 6 months.

Exclusion criteria

1. Any clinically significant chronic or acute medical condition that makes the participant unsuitable for participation.
2. Significant liver fibrosis or cirrhosis.
3. History or evidence of drug or alcohol abuse.
4. History of intolerance to SC or IM injection.
5. History of chronic liver disease from any cause other than chronic HBV infection.
6. History of hepatic decompensation.
7. Contraindications to the use of PEG-IFNα.

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

Primary outcomes

Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint

Time frame: 24 weeks post end of treatment

Secondary outcomes

Percentage of participants achieving HBsAg seroclearance at 24 weeks post end of study treatment in anti-HBs responders compared with non-responders defined at protocol-specific timepoint (in participants with lower baseline HBsAg levels)

Time frame: 24 weeks post end of treatment
Percentage of participants with treatment-emergent adverse events (TEAEs)

Time frame: 24 weeks post NRTI discontinuation
Percentage of participants with serious adverse events (SAEs)

Time frame: 24 weeks post NRTI discontinuation
Percentage of participants with abnormalities in hematology, chemistry, and/or coagulation parameters

Time frame: 24 weeks post NRTI discontinuation
Appearance of anti-HBs at any timepoint

Time frame: 24 weeks post NRTI discontinuation
Titers of anti-HBs at any timepoint

Time frame: 24 weeks post NRTI discontinuation

Sponsors and collaborators

Lead sponsor

Brii Biosciences Limited

Industry

Collaborators

Vir Biotechnology, Inc.

Registry information

Official study title

A Phase 2 Multicenter, Open-label Study to Investigate the Efficacy and Safety of Regimens Containing BRII-179, BRII-835, and Pegylated Interferon Alpha (PEG-IFNα) for the Treatment of Chronic Hepatitis B Virus (HBV) Infection (ENRICH)

Important dates

Study start: 2024
Primary completion: 2026
Study completion: 2027
First posted: Jul 9, 2024
Registry last updated: Dec 30, 2024

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.