A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection
A Global, Randomized, Open-label, Multicenter, Phase 2b/3 Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection (AZURE-1)
1 other identifier
interventional
150
12 countries
38
Brief Summary
This is a Phase 2b/3 study designed to evaluate the safety and efficacy of chronic treatment with brelovitug (a.k.a BJT-778; BTG) for chronic hepatitis delta virus (HDV) infection. The comparator in this study will be 24-weeks of delayed treatment. During the 24-weeks of delayed treatment, participants will complete the same visits and assessments as those randomized to initiate brelovitug immediately. At the completion of 24-week delayed treatment period, all participants will start treatment with brelovitug.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Mar 2025
Typical duration for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 25, 2025
CompletedFirst Submitted
Initial submission to the registry
March 26, 2025
CompletedFirst Posted
Study publicly available on registry
April 2, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
March 2, 2026
February 1, 2026
4.1 years
March 26, 2025
February 26, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of participants with a composite endpoint
Achieving composite endpoint defined as virologic response (undetectable HDV RNA or decline in HDV RNA ≥2 log10 IU/mL) and ALT normalization
Week 24
Secondary Outcomes (4)
Percentage of participants with treatment-emergent adverse events (TEAE) as assessed by DAIDS
Weeks 24, 48, 96, and 120, if applicable
Percentage of participants that achieve that achieve virologic response and ALT normalization
Weeks 24, 48, 96, and 120, if applicable
Percentage of participants with a composite endpoint by treatment regimen
Weeks 24, 48, 96, and 120, if applicable
Percentage of participants with HDV associated liver disease progression
Weeks 24, 48, 96, and 120, if applicable
Study Arms (3)
Brelovitug 300mg
EXPERIMENTALDose - brelovitug 300 mg Frequency- once weekly
Brelovitug 900mg
EXPERIMENTALDose - brelovitug 900 mg Frequency- once every 4 weeks
Delayed Treatment with brelovitug 300mg
ACTIVE COMPARATORDose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly
Interventions
Route of administration- Subcutaneous Injection
Eligibility Criteria
You may qualify if:
- Willing and able to provide written informed consent.
- Chronic HDV infection
- HDV RNA \>500 IU/mL at Screening.
- Abnormal ALT (\>upper limit of normal) at Screening.
- Willing to take or already taking HBV nucleos(t)ide therapy
You may not qualify if:
- Pregnant or nursing females.
- Unwilling to comply with contraception requirements during the study.
- Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy
- Presence of other liver disease(s) (does not include HBV or HDV infection) such as non-alcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, hepatocellular carcinoma.
- Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (38)
247 Garden Grove
Garden Grove, California, 92840, United States
242 Huntington Beach
Huntington Beach, California, 92647, United States
252 Long Beach
Long Beach, California, 90805, United States
244 Los Angeles
Los Angeles, California, 90033, United States
250 Miami
Miami, Florida, 33166, United States
251, Illinois
Chicago, Illinois, 60612, United States
248 Lowa
Cities in Iowa, Iowa, 52242, United States
254 Baltimore
Baltimore, Maryland, 21287, United States
241, Massachusetts
Boston, Massachusetts, 02114, United States
245 New York
New York, New York, 10007, United States
256 New York
New York, New York, 10065, United States
253 New York
New York, New York, 10075, United States
255 New York
New York, New York, 10075, United States
257 Philadelphia
Philadelphia, Pennsylvania, 19104, United States
249 San Antonio
San Antonio, Texas, 78215, United States
102 Melbourne
Melbourne, Victoria, Australia
101 Camperdown
Camperdown, Australia
104 Liverpool
Liverpool, Australia
703 Sliven
Sliven, Silven, 8800, Bulgaria
705 Plovdiv
Plovdiv, Bulgaria
702 Bulgaria
Sofia, Bulgaria
706 Sofia
Sofia, Bulgaria
704 Stara Zagora
Stara Zagora, Bulgaria
233 Calgary
Calgary, Calgary, Canada
234 Alberta
Edmonton, Edmonton, T6G 2G5, Canada
231 Toronto
Toronto, Ontario, Canada
235 Montreal
Montreal, Quebec, Canada
181 Tbilisi
Tbilisi, 0105, Georgia
183 Tbilisi
Tbilisi, 0105, Georgia
182 Tbilisi
Tbilisi, Georgia
212 Haifa
Haifa, Haifa District, Israel
211 Israel
Beersheba, Israel
901 Chisinau
Chisinau, Moldova
001 Auckland
Auckland, New Zealand
221 Karachi City
Karachi, Karachi, Pakistan
291 Belgrade
Belgrade, Belgrade, Serbia
191 Istanbul
Istanbul, Istanbul, Turkey (Türkiye)
110 Kyiv
Kyiv, 01001, Ukraine
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 26, 2025
First Posted
April 2, 2025
Study Start
March 25, 2025
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
September 1, 2029
Last Updated
March 2, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will not share