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)

NCT06650852
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Phase
Phase 2
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Recruitment status
Recruiting
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Participants
250
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Lead sponsor
Brii Biosciences Limited
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Start date
2024-10-31
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Number of sites
14
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Summary
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.
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Short title
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)
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Official 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)
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Control arm
Active comparator
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Recruiting
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Phase
Phase 2
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Study type
Interventional
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Completion date
2029-09-01
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First posted
2024-10-21
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Registry last updated
2026-10-22
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Primary completion date
2028-09-01
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Start date
2024-10-31
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Participants
250
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Participant count basis
Estimated
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Planned participants
250
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Protocol amendments
1
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Number of sites
14
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Registry sponsor category
Industry
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Lead sponsor
Brii Biosciences Limited
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Source registry
ClinicalTrials.gov
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Registry ID
NCT06650852
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ClinicalTrials.gov ID
NCT06650852
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Registry record
Open registry record
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Allocation
Randomised
Model
Parallel groups
Purpose
Treatment
Masking
Double masking
Masked roles
Participants, Investigators
Sources for study design
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  1. The percentage of participants achieving HBsAg seroclearance.

    Timeframe: Up to 48 weeks

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

    Timeframe: Up to 96 weeks

  1. Percentage of participants achieving HBsAg seroconversion.

    Timeframe: Up to 48 weeks

  2. Percentage of participants achieving HBsAg seroclearance.

    Timeframe: Up to 72 weeks

  3. Percentage of participants achieving HBsAg seroconversion.

    Timeframe: Up to 72 weeks

  4. Percentage of participants achieving functional cure.

    Timeframe: Up to 96 weeks

Sources for outcomes
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Sex
All
Age groups
Adults
Minimum age
18 Years
Maximum age
60 Years
Healthy volunteers
No

  • 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.

  • 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.
Sources for eligibility
clinicaltrials.gov

  • Investigative Site 86001Beijing, ChinaRecruiting
  • Investigative Site 86003Beijing, ChinaRecruiting
  • Investigative Site 86004Beijing, ChinaRecruiting
  • Investigative Site 86005Beijing, ChinaRecruiting
  • Investigative Site 86016Beijing, ChinaRecruiting
  • Investigative Site 86002Guangzhou, ChinaRecruiting
  • Investigative Site 86013Guangzhou, ChinaRecruiting
  • Investigative Site 86015Shenzhen, ChinaRecruiting
  • Investigative Site 86006Shanghai, ChinaRecruiting
  • Investigative Site 86007Shanghai, ChinaRecruiting
  • Investigative Site 86010Chengdu, ChinaRecruiting
  • Investigative Site 86011Chengdu, ChinaRecruiting
  • Investigative Site 86012Chengdu, ChinaRecruiting
  • Investigative Site 86009Hangzhou, ChinaRecruiting
Sources for sites
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)