Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial registered on ANZCTR
Registration number
ACTRN12625000173493
Ethics application status
Approved
Date submitted
4/12/2024
Date registered
14/02/2025
Date last updated
6/04/2025
Date data sharing statement initially provided
14/02/2025
Type of registration
Prospectively registered
Titles & IDs
Public title
A Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod in Subjects with Chronic Hepatitis B Infection
Query!
Scientific title
A Phase 1b/2 Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod Alone and in Combinations in Participants with Chronic Hepatitis B Infection- Part D
Query!
Secondary ID [1]
313328
0
BJT-008-001
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
This registration is linked to ACTRN12624000809538 (Part B of the study) and ACTRN12624000808549 (Part A of the study). The study has been expanded to include Part C (ACTRN12625000142437) and Part D (this registration) via a protocol amendment.
Query!
Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis B Infection
335687
0
Query!
Condition category
Condition code
Infection
332248
332248
0
0
Query!
Other infectious diseases
Query!
Intervention/exposure
Study type
Interventional
Query!
Description of intervention(s) / exposure
Investigational Product (IP): Cavrotolimod, Nivolumab and BJT-778
Dosage Form: Vial
Method of administration: Sub cutaneous injection (SC)
Dose: Cavrotolimod will be supplied as 2mL vial; Nivolumab will be supplied as 4mL vial and BJT-778 will be supplied as 6 mL glass vial.
This study consists of 4 parts (Part A, B, C and D). This registration is for Part D. Part D will evaluate up to 48-week combination regimen(s) with cavrotolimod ± BJT-778 ± lowdose nivolumab for the treatment of Chronic Hepatitis B infection (CHB). The open-label combination regimens(s) to be tested in Part D will be confirmed by the SRC based on review of emerging safety, tolerability, antiviral activity, and PK/PD, including BJT-008-001 Part B (ACTRN12624000809538) and Part C and BJT-778-001 evaluating BJT-778 900 mg administered SC every 4 weeks in combination with low-dose nivolumab 0.3 mg/kg IV at Week 4 and 24. This will include review of 8-week safety data from BJT-008-001 Part B, 4week safety data from BJT-008-001 Part C, and 24-weeks of safety data from BJT-778-001 Cohort G (New protocol in development with BJT-778 and Nivolumab).
The combination regimen(s) will not exceed a total duration of 48 weeks. The difference between these cohorts will be determined by the SRC at the time of opening. Cohorts 2 and 3 are optional cohorts and may open upon SRC decision.
• Cohort 1, Arm 1 and Expansion Arm 1a will receive Cavrotolimod (less than equal to 24 mg) SC ± BJT-778 900 mg SC every 4 weeks ± low-dose nivolumab (0.3 mg/kg) every 3 months for up to 48 weeks
• Optional Cohort 2, Arm 1 and Expansion Arm 1a will receive Cavrotolimod (less than equal to 24 mg) SC ± BJT-778 900 mg SC every 4 weeks ± low-dose nivolumab (0.3 mg/kg) every 3 months for up to 48 weeks
• Optional Cohort 3, Arm 1 and Expansion Arm 1a will receive Cavrotolimod (less than equal to 24 mg) SC ± BJT-778 900 mg SC every 4 weeks ± low-dose nivolumab (0.3 mg/kg) every 3 months for up to 48 weeks
Participants will be followed for 24 weeks after the last dose of study medications. Participants who achieve HBsAg loss (HBsAg <LLOQ) at the end of follow up will continue to be followed for an additional 24 weeks (total 48 weeks of follow up). Part D may not start until after review of the 4-week safety data from Part C.
Interim safety, tolerability and available efficacy data will be reviewed by the SRC when the first =5 participants in a cohort A have completed 12 weeks of treatment and 24 weeks of treatment. The SRC can recommend modification to study medication or safety monitoring, discontinue a treatment arm, or discontinue the study. Additional cohorts may also be initiated based on the emerging data and SRC recommendation. The selected dose(s), regimen(s), and combination(s) to be evaluated in Part D will be agreed upon by the SRC.
Query!
Intervention code [1]
329911
0
Treatment: Drugs
Query!
Comparator / control treatment
None.
All assessments before the first dose of study medication will be considered as baseline. If there are multiple baseline assessments, the most recent one will be used for statistical analysis.
Query!
Control group
Uncontrolled
Query!
Outcomes
Primary outcome [1]
339822
0
To evaluate the safety and tolerability of cavrotolimod alone and in combinations. - Incidence and severity of treatment-emergent adverse events (TEAEs) will be assessed for severity and causality (relationship of event to the investigational product) by the study investigator using the specified definitions. AEs/SAEs will be coded and tabulated using the Medical Dictionary for Regulatory Activities (current version at study start). - Changes in clinical laboratory parameters including blood tests for complete blood count. coagulation, serum chemistry, and urinalysis. - Change in vital signs measurements. Vital signs include measurement of heart rate (HR) respiration rate (RR), systolic and diastolic blood pressure (BP) and body temperature. BP and HR will be measured by an automated BP Machine, RR is a manual calculation where the staff member will count the rise/fall of the chest and temperature will be measured by a digital tympanic thermometer - Changes in the electrocardiogram (ECG) findings) for exclusion criteria 12. Symptoms-driven ECGs may be collected at any time during the study for cardiac evaluation/assessment. Any symptoms-driven ECG that has clinically significant changes will be captured as an AE. All measures will be assessed as a composite outcome
Query!
Assessment method [1]
339822
0
- Incidence and severity of treatment-emergent adverse events (TEAEs) will be assessed for severity and causality (relationship of event to the investigational product) by the study investigator using the specified definitions. Common Terminology Criteria for Adverse Events (CTCAE) (V5.0) as 5 grades. - Changes in clinical laboratory parameters including blood tests for complete blood count. coagulation, serum chemistry, and urinalysis. - Change in vital signs measurements. Vital signs include measurement of heart rate (HR) respiration rate (RR), systolic and diastolic blood pressure (BP) and body temperature. BP and HR will be measured by an automated BP Machine, RR is a manual calculation where the staff member will count the rise/fall of the chest and temperature will be measured by a digital tympanic thermometer - Change in ECG parameters assessed including change in rhythm, PR interval, heart rate, QRS interval, QT interval, QTcF interval, and QRS axis. All measures will be assessed as a composite outcome
Query!
Timepoint [1]
339822
0
- Adverse events monitored once every 4 weeks from screening to 24 weeks post first dose administration. - Safety Lab parameters will be assessed on screening, Day 1, Day 29, FU12, FU24, and First and Last dose of Cavrotolimod and 1st dose of Nivolumab and at 14days post dose. This will change based on the dosing frequency determinedd by the SRC. - Vital signs will be assessed once every 4 weeks from screening to 24 weeks post first dose administration. Vitals are also taken on each Cavrotolimod dose and at +24h and +48h post dose. Relative to Nivolumab dosing day vitals are taken on day 1, 7days post dose and 14days post dose. - ECG will be checked on screening.
Query!
Secondary outcome [1]
441518
0
To evaluate the plasma pharmacokinetics (PK) of cavrotolimod alone, in combinations, and/or other study medication(s) (e.g. BJT-778)
Query!
Assessment method [1]
441518
0
Assessments of the following PK parameters- Cmax: Maximum Plasma Concentration Tmax: Time of the maximum measured plasma concentration AUC (0 to t): Area Under the Plasma Concentration. AUC (Inf): Area Under the Plasma Concentration T 1/2: Apparent first-order terminal elimination half life Vd: Volume of dosctribution
Query!
Timepoint [1]
441518
0
Blood samples will be collected at single timepoint from screening, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 196, Day 224, day 252, Day 280, Day 308, Day 336 till 48 weeks follow up weeks since last dose administration
Query!
Secondary outcome [2]
441521
0
To evaluate efficacy of cavrotolimod combination treatment
Query!
Assessment method [2]
441521
0
Proportion of subjects who achieve more than equal to 10 IU/mL HBsAg decline at the end of treatment and during follow up
Query!
Timepoint [2]
441521
0
Blood samples will be collected on screening, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 196, Day 224, day 252, Day 280, Day 308, Day 336 till 48 weeks follow up weeks since last dose administration.
Query!
Secondary outcome [3]
441520
0
To evaluate the anti-hepatitis B virus (HBV) activity of cavrotolimod alone and in combinations
Query!
Assessment method [3]
441520
0
This is evaluated by following - -Absolute and change from baseline in HBsAg over time -Maximum reduction from baseline of HBsAg levels during treatment -HBsAg loss {
Query!
Timepoint [3]
441520
0
Blood samples will be collected on screening, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 196, Day 224, day 252, Day 280, Day 308, Day 336 till 48 weeks follow up weeks since last dose administration
Query!
Secondary outcome [4]
441519
0
To evaluate the pharmacodynamics (PD) of cavrotolimod alone and in combinations
Query!
Assessment method [4]
441519
0
•Absolute and change from baseline of key cytokines/chemokines over time • Absolute and change from baseline in HBsAg (Hepatitis B surface antigen) over time. • Maximum reduction from baseline of HBsAg levels during treatment
Query!
Timepoint [4]
441519
0
Blood samples will be collected on screening, Day 1, Day 29, Day 57, Day 85, Day 113, Day 141, Day 169, Day 196, Day 224, day 252, Day 280, Day 308, Day 336 till 48 weeks follow up weeks since last dose administration
Query!
Eligibility
Key inclusion criteria
1. Male or female adults between 18 and 65 years of age, inclusive
2. Chronic HBV infection greater than or equal to 6 months (e.g., positive for serum HBsAg greater than or equal to 6 months)
3. Taking a commercially available nucleos(t)ide analogs for at least 2 months prior to Screening, and willing to remain on stable treatment for the duration of the study, unless they achieve nucleos(t)ide stopping criteria.
4. HBV DNA less than 100 IU/mL in blood at Screening
5. HBsAg at Screening:
a. Part D: >LLOQ to 3000 IU/mL. The upper limit of 3000 IU/mL may be removed based on emerging data.
Query!
Minimum age
18
Years
Query!
Query!
Maximum age
65
Years
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
1. Pregnant or nursing females
2. Male or female participants of childbearing potential unwilling to comply with contraception requirements during the study
3. Fibroscan greater than or equal to 8.5 kPa within 1 year of Screening
4. History of and/or current decompensated liver disease as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal variceal bleeding
5. Presence of liver disease, not including chronic HBV infection, such as nonalcoholic steatohepatitis (NASH), alcohol-associated hepatitis, cholestatic liver disease, other viral (e.g., HCV or HDV) 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 greater than or equal to 6 months prior to Screening.
6. Positive for HIV, HDV, or HCV infection at Screening
7. Received solid organ or bone marrow transplant
8. Chronic systemic immunosuppressive therapy (e.g., prednisone) within 1 month of Screening or require the use of during the study.
9. Prior or current history of hepatocellular carcinoma (HCC) or suspected HCC as evidenced by screening alpha-fetoprotein greater than or equal to 20 ng/mL
10. History of hypersensitivity to any of the components in the cavrotolimod, BJT-778 or nivolumab formulation components or severe reactions to injections
11. Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values that would render a participant unsuitable for inclusion:
a. Presence of anti-thyroid antibodies (anti-thyroid-stimulating hormone receptor, anti-thyroglobulin [TG], or anti- thyroid peroxidase [TPO])
b. Abnormal thyroid stimulating hormone
c. Anti-nuclear antibody greater than 1:160
d. ALT or aspartate aminotransferase (AST) greater than 2× upper limit of normal (ULN)
e. Total bilirubin greater than 1.2× ULN, except for participants with Gilbert’s (normal direct bilirubin)
f. Serum albumin less than .5 g/dL
g. International normalized ratio (INR) greater than 1.2
h. Platelet count less than 140 K/mm3
i. Hemoglobin less than 12.0 g/dL for males and <11.0 g/dL for females
j. Absolute neutrophil count less than 1000/mm3
k. Estimated glomerular filtration rate less than 50 mL/min/1.73 m2 by Cockcroft-Gualt
12. 12-lead electrocardiogram (ECG) showing the following: having a corrected QTc interval greater than 450 msec for males and greater than 470 msec for females or <340 msec (Fridericia’s correction)
13. Clinically significant medical history of:
a. Cardiac diseases (e.g., myocardial infarctions, stroke, arrhythmia, heart failure, and coronary heart disease)
b. Autoimmune diseases (e.g., lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis, thyroiditis), or
c. Malignancies within 3 years. Malignancy that has been successfully surgically resection and considered cured would not exclude the participant
14. Treatment with an investigational drug, biological agent or device within 4 weeks or 5 half-lives prior to Screening, whichever is longer.
15. History of excess alcohol consumption within 1 year of Screening, defined as weekly intake of greater than or equal to 14 drinks per week (average of greater than or equal to 2 drinks per day)
16. History of drug abuse/addiction within 6 months of Screening (except cannabis)
17. 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 individual participating in or completing the study
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Non-randomised trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Open (masking not used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Safety/efficacy
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Not yet recruiting
Query!
Date of first participant enrolment
Anticipated
6/10/2025
Query!
Actual
Query!
Date of last participant enrolment
Anticipated
31/03/2026
Query!
Actual
Query!
Date of last data collection
Anticipated
30/09/2027
Query!
Actual
Query!
Sample size
Target
90
Query!
Accrual to date
Query!
Final
Query!
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Query!
Recruitment outside Australia
Country [1]
26951
0
Philippines
Query!
State/province [1]
26951
0
Query!
Country [2]
26699
0
Ukraine
Query!
State/province [2]
26699
0
Query!
Country [3]
26698
0
Hong Kong
Query!
State/province [3]
26698
0
Query!
Country [4]
26695
0
New Zealand
Query!
State/province [4]
26695
0
Auckland
Query!
Country [5]
26697
0
Taiwan, Province Of China
Query!
State/province [5]
26697
0
Query!
Country [6]
26696
0
Moldova, Republic Of
Query!
State/province [6]
26696
0
Query!
Funding & Sponsors
Funding source category [1]
317781
0
Commercial sector/Industry
Query!
Name [1]
317781
0
Bluejay Therapeutics, Inc
Query!
Address [1]
317781
0
Query!
Country [1]
317781
0
United States of America
Query!
Primary sponsor type
Commercial sector/Industry
Query!
Name
Bluejay Therapeutics, Inc
Query!
Address
Query!
Country
United States of America
Query!
Secondary sponsor category [1]
320099
0
None
Query!
Name [1]
320099
0
Query!
Address [1]
320099
0
Query!
Country [1]
320099
0
Query!
Other collaborator category [1]
283295
0
Commercial sector/Industry
Query!
Name [1]
283295
0
Novotech(Australia) Pty Limited
Query!
Address [1]
283295
0
Query!
Country [1]
283295
0
Australia
Query!
Ethics approval
Ethics application status
Approved
Query!
Ethics committee name [1]
316465
0
Bellberry Human Research Ethics Committee D
Query!
Ethics committee address [1]
316465
0
https://bellberry.com.au/
Query!
Ethics committee country [1]
316465
0
Australia
Query!
Date submitted for ethics approval [1]
316465
0
04/12/2024
Query!
Approval date [1]
316465
0
Query!
Ethics approval number [1]
316465
0
Query!
Ethics committee name [2]
316555
0
Northern A Health and Disability Ethics CommitteeÂ
Query!
Ethics committee address [2]
316555
0
https://ethics.health.govt.nz/about/northern-a-health-and-disability-ethics-committee/
Query!
Ethics committee country [2]
316555
0
New Zealand
Query!
Date submitted for ethics approval [2]
316555
0
29/11/2024
Query!
Approval date [2]
316555
0
30/01/2025
Query!
Ethics approval number [2]
316555
0
Query!
Ethics committee name [3]
316554
0
St Vincent’s Hospital Human Research Ethics Committee
Query!
Ethics committee address [3]
316554
0
https://svhs.org.au/home/research-education/research-office
Query!
Ethics committee country [3]
316554
0
Australia
Query!
Date submitted for ethics approval [3]
316554
0
06/12/2024
Query!
Approval date [3]
316554
0
21/03/2025
Query!
Ethics approval number [3]
316554
0
HREC 120/24
Query!
Summary
Brief summary
This is a Phase 2 study to evaluate the safety and tolerability, PK/PD, and antiviral activity/efficacy of cavrotolimod and cavrotolimod-containing combinations in CHB infected subjects who are on nucleos(t)ide therapy. Cavrotolimod +Nivolumab+ BJT-778 is being developed to address the high unmet medical need with possible benefits for participants with Chronic Hepatis B virus infection (CHB). This study will enroll non-cirrhotic, chronic hepatitis B (CHB) infected adults aged 18-65 years of age, inclusive, on nucleos(t)ide therapy. The study consists of four parts (Part A, Part B, Part C and Part D). Part D will enroll up to 90 participants. 15 to 30 participants per cohort across 3 possible cohorts.
Query!
Trial website
Query!
Trial related presentations / publications
Query!
Public notes
Query!
Contacts
Principal investigator
Name
137974
0
Prof Edward Gane
Query!
Address
137974
0
New Zealand Clinical Research, Grd floor, 3 Ferncroft St, Grafton Auckland 1010 New Zealand
Query!
Country
137974
0
New Zealand
Query!
Phone
137974
0
+64 21 548 371
Query!
Fax
137974
0
Query!
Email
137974
0
[email protected]
Query!
Contact person for public queries
Name
137975
0
Ms. Carole Ann Moore
Query!
Address
137975
0
Bluejay Therapeutics Inc., 255 Shoreline Drive, Suite 450, Redwood City, CA 94065, USA
Query!
Country
137975
0
United States of America
Query!
Phone
137975
0
+1 650 796 5003
Query!
Fax
137975
0
Query!
Email
137975
0
[email protected]
Query!
Contact person for scientific queries
Name
137976
0
Susanna Tan, Senior Director, Clinical Development
Query!
Address
137976
0
Bluejay Therapeutics Inc., 255 Shoreline Drive, Suite 450, Redwood City, CA 94065, USA
Query!
Country
137976
0
United States of America
Query!
Phone
137976
0
+1 925 998 6824
Query!
Fax
137976
0
Query!
Email
137976
0
[email protected]
Query!
Data sharing statement
Will the study consider sharing individual participant data?
No
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
Download to PDF