BJT-778 for Chronic hepatitis D (Hepatitis Delta Infection)

Inclusion criteria

• {"criterion_text":"- Willing and able to provide written informed consent.\n- Male or female, ≥18 years of age at Screening.\n- Confirmation of chronic HDV infection, defined as positive for anti-HDV antibody test or HDV RNA for at least 6 months prior to Day 1. If prior documentation is not available, then HDV RNA positivity along with evidence of fibrosis (liver stiffness of ≥7 kPa) is acceptable.\n- HDV RNA >500 IU/mL at Screening.\n- ALT >ULN at Screening.\n- Taking or willing to take tenofovir disoproxil fumarate (TDF), tenofovir alafenamide fumarate (TAF), or entecavir (ETV) at baseline, and willing to remain on stable treatment for the duration of the study."}

Exclusion criteria

• {"criterion_text":"- Pregnant or nursing females.\n- Use of any prohibited concomitant medications as described in Section 7.7.\n- Regular alcohol misuse, defined as weekly intake of ≥14 alcoholic drinks per week (average of ≥2 alcoholic drinks per day) within 12 months of Screening.\n- Clinically relevant drug abuse (not including cannabis) within 12 months of Screening.\n- Unwillingness to comply with study procedures as specified by this protocol, or unwillingness to cooperate fully with the Investigator.\n- Have any other conditions (medical, social, psychiatric, or other), which in the opinion of the Investigator would make the participant unsuitable for inclusion or could interfere with the participant participating in or completing the study.\n- Male or female participants of childbearing potential unwilling to comply with contraception requirements during the study.\n- Current, prior history, or is under evaluation for any of the following: a) Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy, b) Clinical hepatic decompensation (i.e., ascites, encephalopathy variceal hemorrhage). Incidental small ascites on imaging without other clinical symptoms/signs would not exclude the participants, c) Hepatocellular carcinoma; suspected HCC on ultrasound at Screening, d) Vasculitis, e) Extrahepatic disorders possibly related to HBV immune complexes (e.g., glomerulonephritis, polyarteritis nodosa), f) Solid organ or bone marrow transplantation, g) Significant pulmonary disease (e.g., O2-dependent or forced expiratory volume 1 second (FEV1) ≤50% predicted value), h) Significant cardiac disease (e.g., history of myocardial infarctions within 6 months, any history of ventricular tachycardia, congestive heart failure, dilated cardiomyopathy with left ventricular ejection fraction <40%), i) Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to Screening).\n- CTP >6 B or C.\n- Presence of other liver disease(s) (non-HBV/HDV), such as nonalcoholic steatohepatitis (NASH), alcohol associated hepatitis, cholestatic liver disease, other viral (e.g., HCV or HAV) or non-viral hepatitis that has the potential to impact interpretation of data. Exceptions to this criterion include fatty liver without any signs of steatohepatitis or past HCV infection that was successfully treated (HCV RNA negative) ≥6 months prior to Screening.\n- Uncontrolled human immunodeficiency virus (HIV) infection defined as having quantifiable HIV RNA levels in the blood at Screening.\n- History of hypersensitivity to any of the components in the brelovitug formulation.\n- Screening laboratory results as follows, or any other clinically significant abnormalities in Screening laboratory values that would render a participant unsuitable for inclusion: a) Platelet count <50,000/mm3 b) Hemoglobin <10.0 g/dL, c) Creatinine clearance by Crockcroft-Gault (CrCl) <30 mL/min, d) Alpha fetoprotein (AFP) >100 ng/mL.\n- Treatment with another investigational drug, a biological agent, or device within 4 weeks or 5 half-lives, whichever is longer, of Baseline."}

Primary endpoints

• {"endpoint_text":"- The proportion of participants who achieve a composite endpoint of virologic response and ALT normalization. • Virologic response is defined as HDV RNA ≥2 log10 IU/mL decrease from Baseline or undetectable HDV RNA (< lower limit of quantification [LLOQ], target not detected [TND]),• ALT normalization is defined as a decrease in ALT from Baseline to ≤UNL. • The primary efficacy analysis will be tested according to the hierarchical testing.","definition_or_measurement_approach":"Composite endpoint combining virologic response and ALT normalization: Virologic response defined as ≥2 log10 IU/mL decrease from Baseline in HDV RNA or undetectable HDV RNA (< LLOQ, TND). ALT normalization defined as decrease in ALT from Baseline to ≤ upper limit of normal (UNL). Primary efficacy analysis tested using hierarchical testing."}

Secondary endpoints

• {"endpoint_text":"- The proportion of participants who achieve a composite endpoint of virologic response and ALT normalization. • Virologic response is defined as HDV RNA ≥2 log10 IU/mL decrease from Baseline or undetectable HDV RNA (< lower limit of quantification [LLOQ], target not detected [TND]),• ALT normalization is defined as a decrease in ALT from Baseline to ≤UNL. • The primary efficacy analysis will be tested according to the hierarchical testing.","definition_or_measurement_approach":"Same composite endpoint as primary; virologic response and ALT normalization defined as above; hierarchical testing noted."}
• {"endpoint_text":"- Safety endpoint will evaluate: • Incidence and severity of treatment-emergent adverse events (TEAE). • Proportion of participants who permanently discontinue treatment due to an adverse event.","definition_or_measurement_approach":"Safety assessed by incidence and severity of TEAEs and proportion permanently discontinuing treatment due to adverse events (standard AE reporting and severity grading)."}
• {"endpoint_text":"- The proportion of participants who achieve the following during treatment: • Virologic response defined as ≥2 log10 IU/mL decline from baseline or undetectable HDV RNA • HDV RNA ","definition_or_measurement_approach":"Proportion achieving virologic response (≥2 log10 IU/mL decline from baseline or undetectable HDV RNA); assessment via HDV RNA quantitative testing (LLOQ/TND)."}
• {"endpoint_text":"- The proportion of participants who achieve a composite endpoint at Weeks 24, 48, and 96.","definition_or_measurement_approach":"Composite endpoint measured at specified timepoints (Weeks 24, 48, 96) using virologic response and ALT normalization criteria."}
• {"endpoint_text":"- • Change from Baseline in liver stiffness as determined by transient elastography (e.g., FibroScan) at Weeks 24, 48, 96, 120 (Arm 3). • Change from Baseline in APRI at Weeks 24, 48, 96, 120 (Arm 3). • Change from Baseline in CTP score at Weeks 24, 48, 96, and 120 (Arm 3) in cirrhotic participants. • Change from Baseline in MELD score at Weeks 24, 48, 96, 120 (Arm 3) in cirrhotic participants.","definition_or_measurement_approach":"Liver disease progression and fibrosis evaluated by change from Baseline in transient elastography (FibroScan), APRI, CTP score and MELD score at specified weeks (24, 48, 96, 120 for Arm 3) using standard measurement instruments and scoring."}
• {"endpoint_text":"- • Proportion of participants with clinical disease progression from Baseline in HDV-associated liver disease at Weeks 24, 48, 96, 120 (Arm 3). Progression will be determined by the IDMC.","definition_or_measurement_approach":"Clinical disease progression assessed at specified weeks; determination of progression adjudicated by Independent Data Monitoring Committee (IDMC)."}
• {"endpoint_text":"- Proportion of participants who achieve HDV RNA ","definition_or_measurement_approach":"Proportion achieving HDV RNA < LLOQ, TND at Weeks 24 and 48 in post-treatment follow-up (HDV RNA quantitative testing)."}

Bulgaria

Earliest CTIS Part Ii Submission Date

16-05-2025

Latest Decision Or Authorization Date

07-04-2026

Processing Time Days

326

Number Of Sites

3

Number Of Participants

30

Primary sponsor

Full Name

Bluejay Therapeutics Inc.

Organisation Type

Pharmaceutical company

Country Of Registered Address

United States

Contract research organisations

Name

Novotech Clinical Research (Cyprus) Limited

Responsibilities

Sponsor/CRO responsibilities including codes 1,10,11,12,2,5,6,8 (as listed in sponsorDuties)

Name

Sonic Clinical Trials Pty Limited

Responsibilities

Storage, shipping (sponsorDuties include 'Storage, shipping' and code 4)

Third parties

• {"country":"Australia","full_name":"Sonic Clinical Trials Pty Limited","duties_or_roles":"Storage, shipping (sponsorDuties ids include 15 and 4)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Sponsor duties codes: 3, 7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"United States","full_name":"Arup Laboratories Inc.","duties_or_roles":"Storage Specimens (sponsorDuties id 15)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"B2s Life Sciences LLC","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Pharmaceutical company"}
• {"country":"Australia","full_name":"VIDRL","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Health care"}
• {"country":"Cyprus","full_name":"Novotech Clinical Research (Cyprus) Limited","duties_or_roles":"Extensive CRO/vendor roles (sponsorDuties codes: 1, 10, 11, 12, 2, 5, 6, 8)","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Acm Global Central Laboratory Limited","duties_or_roles":"Storage (sponsorDuties include 'Storage' and code 4)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Australia","full_name":"Resolian","duties_or_roles":"Sponsor duties code: 4","organisation_type":"Industry"}
• {"country":"United States","full_name":"Acm Medical Laboratory Inc.","duties_or_roles":"Storage (sponsorDuties include 'Storage' and code 4)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"The Doctors Laboratory Limited","duties_or_roles":"Storage Specimens (sponsorDuties id 15)","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"Netherlands","full_name":"DDL Diagnostic Laboratory B.V.","duties_or_roles":"Storage Specimens (sponsorDuties include 'Storage Specimens' and code 4)","organisation_type":"Laboratory/Research/Testing facility"}