Chronic Hepatitis D InfectionPhase 2/3NCT06907290
A Trial Evaluating BJT-778 vs Delayed Treatment for the Treatment of Chronic Hepatitis Delta Infection
A Phase 2/3 study testing Brelovitug 300 mg, Brelovitug 900 mg and Delayed Treatment with Brelovitug 300mg in people with Chronic Hepatitis D Infection, run by Mirum Pharmaceuticals, Inc. at 30 sites in 11 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hepatitis D Infection
- What is being tested?
- Brelovitug 300 mg, Brelovitug 900 mg and Delayed Treatment with Brelovitug 300mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 30 sitesin 11 countries
- Study dates
- 25 Mar 2025to Sep 2029
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
- Solid organ or bone marrow transplantation Note: other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
30 sites in 11 countries.
30 sites in 11 countries
United States10 sites
254 Baltimore
Baltimore, Maryland, 21287
251, Illinois
Chicago, Illinois, 60612
248 Lowa
Cities in Iowa, Iowa, 52242
252 Long Beach
Long Beach, California, 90805
244 Los Angeles
Los Angeles, California, 90033
245 New York
New York, New York, 10007
256 New York
New York, New York, 10065
253 New York
New York, New York, 10075
255 New York
New York, New York, 10075
257 Philadelphia
Philadelphia, Pennsylvania, 19104
Canada4 sites
233 Calgary
Calgary, Calgary
234 Alberta
Edmonton, Edmonton, T6G 2G5
235 Montreal
Montreal, Quebec
231 Toronto
Toronto, Ontario
Australia3 sites
101 Camperdown
Camperdown
104 Liverpool
Liverpool
102 Melbourne
Melbourne, Victoria
Bulgaria3 sites
705 Plovdiv
Plovdiv
703 Sliven
Sliven, Silven, 8800
704 Stara Zagora
Stara Zagora
Georgia3 sites
181 Tbilisi
Tbilisi, 0105
183 Tbilisi
Tbilisi, 0105
182 Tbilisi
Tbilisi
About this study
Official title: 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)
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.
Read the detailed description
Study will consist of 3 study arms. Approximately 150 participants will be randomized 2:2:1 to one of the following treatment arms:
- Arm 1: Participants randomized to Arm 1 will receive brelovitug 300 mg subcutaneously once weekly.
- Arm 2: Participants randomized to Arm 2 will receive brelovitug 900 mg subcutaneously once every 4 weeks.
- Arm 3: Participants randomized to Arm 3 will attend study clinic visits and delay treatment with brelovitug. At Week 24, all participants will receive brelovitug 300 mg subcutaneously once weekly.
- Conditions
- Chronic Hepatitis D Infection
- Being tested
- Brelovitug 300 mg, Brelovitug 900 mg, Delayed Treatment with Brelovitug 300mg
- Keywords
- Hepatitis Delta virus, HDV, Hepatitis D infection, Hepatitis D virus
- Medical subject headings
- Hepatitis D
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brelovitug 300 mgDrug
Route of administration- Subcutaneous Injection
Brelovitug 900 mgDrug
Route of administration- Subcutaneous Injection
Delayed Treatment with Brelovitug 300mgDrug
Route of administration- Subcutaneous Injection
| Study group | Role | What they receive |
|---|---|---|
| Brelovitug 300mg | Experimental | Dose - brelovitug 300 mg Frequency- once weekly Receives: Drug: Brelovitug 300 mg |
| Brelovitug 900mg | Experimental | Dose - brelovitug 900 mg Frequency- once every 4 weeks Receives: Drug: Brelovitug 900 mg |
| Delayed Treatment with brelovitug 300mg | Active comparator | Dose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly Receives: Drug: Delayed Treatment with Brelovitug 300mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Week 24
Secondary outcomes (4)
Percentage of participants with treatment-emergent adverse events (TEAE) as assessed by DAIDS
Frequency and severity of TEAEs and serious AEs
Measured: Weeks 24, 48, 96, and 120, if applicable
Percentage of participants that achieve that achieve virologic response and ALT normalization
Change from baseline in HDV RNA and ALT normalization
Measured: Weeks 24, 48, 96, and 120, if applicable
Percentage of participants with a composite endpoint by treatment regimen
Compare the composite endpoint response (change from baseline HDV RNA and ALT normalization) between weekly versus every 4-week regimen of brelovitug
Measured: Weeks 24, 48, 96, and 120, if applicable
Percentage of participants with HDV associated liver disease progression
Determined by an independent data monitoring committee based on changes in liver stiffness, APRI, CPT/MELD score (cirrhotic), and TEAEs.
Measured: Weeks 24, 48, 96, and 120, if applicable
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2025
- Study start25 Mar 2025
- Primary completionMay 2029 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis D InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mirum Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06907290
- Sponsor's protocol ID
- BJT-778-301
- Status last verified
- Oct 2026
- First submitted
- 26 Mar 2025
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
- Expanded access
- Available
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT06907290
- Acronym / sponsor ID
- BJT-778-301
- Conditions
- Chronic Hepatitis D Infection
- Keywords
- Hepatitis Delta virus, HDV, Hepatitis D infection, Hepatitis D virus
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mirum Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- May 2029 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 2 Apr 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Study will consist of 3 study arms. Approximately 150 participants will be randomized 2:2:1 to one of the following treatment arms:
- Arm 1: Participants randomized to Arm 1 will receive brelovitug 300 mg subcutaneously once weekly.
- Arm 2: Participants randomized to Arm 2 will receive brelovitug 900 mg subcutaneously once every 4 weeks.
- Arm 3: Participants randomized to Arm 3 will attend study clinic visits and delay treatment with brelovitug. At Week 24, all participants will receive brelovitug 300 mg subcutaneously once weekly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brelovitug 300mg | Experimental | Drug: Brelovitug 300 mgDose - brelovitug 300 mg Frequency- once weekly |
| Brelovitug 900mg | Experimental | Drug: Brelovitug 900 mgDose - brelovitug 900 mg Frequency- once every 4 weeks |
| Delayed Treatment with brelovitug 300mg | Active comparator | Drug: Delayed Treatment with Brelovitug 300mgDose - brelovitug 300 mg Frequency- 24 weeks of delayed treatment, then once weekly |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brelovitug 300 mgRoute of administration- Subcutaneous Injection | Drug | Brelovitug 300mg |
| Brelovitug 900 mgRoute of administration- Subcutaneous Injection | Drug | Brelovitug 900mg |
| Delayed Treatment with Brelovitug 300mgRoute of administration- Subcutaneous Injection | Drug | Delayed Treatment with brelovitug 300mg |
Primary outcome
Percentage of participants with a composite endpoint
Time frame: Week 24
Achieving composite endpoint defined as virologic response (undetectable HDV RNA or decline in HDV RNA ≥2 log10 IU/mL) and ALT normalization
4 secondary outcomes
Percentage of participants with treatment-emergent adverse events (TEAE) as assessed by DAIDS
Time frame: Weeks 24, 48, 96, and 120, if applicable
Percentage of participants that achieve that achieve virologic response and ALT normalization
Time frame: Weeks 24, 48, 96, and 120, if applicable
Percentage of participants with a composite endpoint by treatment regimen
Time frame: Weeks 24, 48, 96, and 120, if applicable
Percentage of participants with HDV associated liver disease progression
Time frame: Weeks 24, 48, 96, and 120, if applicable
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
30 sites in 11 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Brelovitug 300 mg, Brelovitug 900 mg and Delayed Treatment with Brelovitug 300mg in people with Chronic Hepatitis D Infection, run by Mirum Pharmaceuticals, Inc. at 30 sites in 11 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 30 sites in United States, Canada, Australia, Bulgaria, Georgia and 6 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of participants with a composite endpoint (time frame: Week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.