Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000416493
Ethics application status
Approved
Date submitted
21/12/2024
Date registered
7/05/2025
Date last updated
7/05/2025
Date data sharing statement initially provided
7/05/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
A Study to Evaluate Tobevibart+Elebsiran in Chronic Hepatitis Delta Virus (HDV) Infection (ECLIPSE 1)
Scientific title
A Phase 3 Randomized, Open-Label Study to Evaluate the Efficacy and Safety of Tobevibart+Elebsiran Combination Therapy in Participants with Chronic HDV Infection (ECLIPSE 1)
Secondary ID [1] 313541 0
Protocol number: VIR-CHDV-V203
Secondary ID [2] 313583 0
EU CT: 2024-515919-22-00
Universal Trial Number (UTN)
Trial acronym
ECLIPSE 1
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis Delta Virus (HDV) Infection 336113 0
Condition category
Condition code
Infection 332665 332665 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Mode of delivery: face to face

Number of times/duration/dose: tobevibart (300mg) + elebsiran (200mg) subcutaneous injections every 4 weeks for up to 240 weeks

Location: Administered at the clinical study site

Strategies used to assess adherence to the intervention: Regular study visits, direct observation during clinic visits, regular study assessments including lab assessments.

Study drug will be administered by a designated staff member experienced in administering subcutaneous injections and delegated the responsibility for study drug administration by the Principal Investigator.
Intervention code [1] 330177 0
Treatment: Drugs
Comparator / control treatment
Delayed treatment in Arm 2.

The control group will be offered the intervention in Week 12.
Control group
Active

Outcomes
Primary outcome [1] 340180 0
To evaluate the efficacy of tobevibart+elebsiran compared with delayed treatment in participants with chronic HDV infection
Timepoint [1] 340180 0
HDV RNA below the LLOQ, TND and ALT normalization at week 48 for Arm 1 (after 48 weeks of study intervention for Arm 1) versus at week 12 for Arm 2 (prior to receipt of any study intervention)
Primary outcome [2] 340181 0
To evaluate the safety of tobevibart+elebsiran in participants with chronic HDV infection
Timepoint [2] 340181 0
Every 4 weeks from Day 1 until week 12 (Arm 1: 12 weeks of study intervention; Arm 2: prior to receipt of any study intervention).
Secondary outcome [1] 443182 0
To evaluate the antiviral effect of tobevibart+elebsiran on HDV viremia compared with delayed treatment in participants with chronic HDV infection
Timepoint [1] 443182 0
At Week 48 for Arm 1 vs at Week 12 for Arm 2
Secondary outcome [2] 443183 0
To evaluate the impact of tobevibart+elebsiran on ALT compared with delayed treatment in participants with chronic HDV infection
Timepoint [2] 443183 0
At Week 48 for Arm 1 vs at Week 12 for Arm 2
Secondary outcome [3] 443184 0
To evaluate the efficacy of tobevibart+elebsiran compared with delayed treatment in participants with chronic HDV infection
Timepoint [3] 443184 0
At Week 48 for Arm 1 vs at Week 12 for Arm 2
Secondary outcome [4] 443185 0
To evaluate the long-term efficacy of tobevibart+elebsiran in participants with chronic HDV infection
Timepoint [4] 443185 0
At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
Secondary outcome [5] 443186 0
To evaluate the long-term antiviral effect of tobevibart+elebsiran on HDV viremia in participants with chronic HDV infection
Timepoint [5] 443186 0
At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
Secondary outcome [6] 443187 0
To evaluate the long-term impact of tobevibart+elebsiran on ALT in participants with chronic HDV infection
Timepoint [6] 443187 0
At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
Secondary outcome [7] 443188 0
To evaluate the long-term impact of tobevibart+elebsiran on liver stiffness in participants with chronic HDV infection
Timepoint [7] 443188 0
At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
Secondary outcome [8] 443190 0
To evaluate the safety of tobevibart+elebsiran in participants with chronic HDV infection
Timepoint [8] 443190 0
Through 48, 96, 144, 192 and 240 weeks of treatment.
Secondary outcome [9] 445150 0
To evaluate the antiviral effect of tobevibart+elebsiran on HDV viremia compared with delayed treatment in participants with chronic HDV infection
Timepoint [9] 445150 0
At Week 48 of treatment for Arm 1 vs at Week 12 of treatment for Arm 2
Secondary outcome [10] 445151 0
To evaluate the antiviral effect of tobevibart+elebsiran on HDV viremia compared with delayed treatment in participants with chronic HDV infection
Timepoint [10] 445151 0
At Week 48 of treatment for Arm 1 vs at Week 12 of treatment for Arm 2
Secondary outcome [11] 445154 0
To evaluate the impact of tobevibart+elebsiran on ALT compared with delayed treatment in participants with chronic HDV infection
Timepoint [11] 445154 0
At Week 48 of treatment for Arm 1 vs at Week 12 of treatment for Arm 2
Secondary outcome [12] 445156 0
To evaluate the impact of tobevibart+elebsiran on ALT compared with delayed treatment in participants with chronic HDV infection
Timepoint [12] 445156 0
At Week 48 of treatment for Arm 1 vs at Week 12 of treatment for Arm 2
Secondary outcome [13] 445158 0
To evaluate the long-term efficacy of tobevibart+elebsiran in participants with chronic HDV infection
Timepoint [13] 445158 0
At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
Secondary outcome [14] 445159 0
To evaluate the long-term efficacy of tobevibart+elebsiran in participants with chronic HDV infection
Timepoint [14] 445159 0
At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
Secondary outcome [15] 445160 0
To evaluate the long-term antiviral effect of tobevibart+elebsiran on HDV viremia in participants with chronic HDV infection
Timepoint [15] 445160 0
At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
Secondary outcome [16] 445161 0
To evaluate the long-term antiviral effect of tobevibart+elebsiran on HDV viremia in participants with chronic HDV infection
Timepoint [16] 445161 0
At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
Secondary outcome [17] 445162 0
To evaluate the long-term impact of tobevibart+elebsiran on ALT in participants with chronic HDV infection
Timepoint [17] 445162 0
At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
Secondary outcome [18] 445163 0
To evaluate the long-term impact of tobevibart+elebsiran on ALT in participants with chronic HDV infection
Timepoint [18] 445163 0
At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
Secondary outcome [19] 445196 0
To evaluate the impact of tobevibart+elebsiran on end stage liver disease outcomes in participants with chronic HDV infection. This will be assessed as two separate outcomes: The first one is: incidence of decompensated cirrhosis
Timepoint [19] 445196 0
By 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
Secondary outcome [20] 445197 0
To evaluate the impact of tobevibart+elebsiran on end stage liver disease outcomes in participants with chronic HDV infection. This will be assessed as two separate outcomes: The second one is: incidence of HCC and progression to liver failure requiring transplantation or resulting in death
Timepoint [20] 445197 0
By 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment

Eligibility
Key inclusion criteria
1) Adult men and women aged greater than or equal to 18 years (or age of legal consent, whichever is older) with HDV RNA greater than or equal to 500 IU/mL at screening.
3) Noncirrhotic or compensated cirrhotic liver disease at screening.
4) Serum alanine aminotransferase (ALT) greater than ULN and less than 5 x ULN
5) Body mass index (BMI) greater than or equal to 18 kg/m2 to less than or equal to 40 kg/m2
6) On NRTI therapy against HBV for at least 12 weeks prior to Day 1 or have HBV DNA less than 20 IU/ml at screening, and currently on one of the following NRTI therapies: tenofovir alafenamide, tenofovir disoproxil fumarate, or entecavir
Note: Other protocol defined Inclusion criteria may apply
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1) Current or prior history of any of the following:
a. Clinically significant laboratory abnormalities, co-morbid medical condition (other than HBV/HDV coinfection) or planned medical procedure that may interfere with the participant’s treatment, assessment, or compliance with the protocol.
b. Difficulty with blood collection and/or poor venous access for the purposes of phlebotomy.
c. Current or previous (within 24 months of screening) clinically identified hepatic decompensation
d. Bone marrow, peripheral blood stem-cell or solid organ transplantation
e. Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of their psychiatric illness within the last 5 years.
f. Malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; ductal carcinoma in situ and cervical carcinoma in situ is allowed if appropriately treated prior to screening); participants under evaluation for malignancy are not eligible.
g. Significant drug allergy (such as anaphylaxis or hepatotoxicity)
2) One or more additional known primary or secondary causes of liver disease, other than hepatitis B or hepatitis D (i.e., alcoholism, autoimmune hepatitis, malignancy with hepatic involvement, hemochromatosis, Wilson’s disease, other congenital or metabolic condition affecting the liver, congestive heart failure, etc).
3) History of clinically significant immune complex disease as determined by the Investigator.
4) History of anaphylaxis, allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites or excipients
5) Participants with active HCV (participants with HCV antibodies can be enrolled if screening HCV RNA PCR test is negative).
6) Participants with HIV infection can be enrolled if CD4+ T-cell counts are greater than 500/mm3 and HIV RNA PCR is below the limit of detection for at least 12 months
Note: Other protocol defined Exclusion criteria may apply

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/05/2025
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment outside Australia
Country [1] 26790 0
New Zealand
State/province [1] 26790 0

Funding & Sponsors
Funding source category [1] 318003 0
Commercial sector/Industry
Name [1] 318003 0
Vir Biotechnology, Inc.
Country [1] 318003 0
United States of America
Primary sponsor type
Commercial sector/Industry
Name
Vir Biotechnology, Inc.
Address
Country
United States of America
Secondary sponsor category [1] 320415 0
None
Name [1] 320415 0
Address [1] 320415 0
Country [1] 320415 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 316664 0
Central Health and Disability Ethics Committee
Ethics committee address [1] 316664 0
Ethics committee country [1] 316664 0
New Zealand
Date submitted for ethics approval [1] 316664 0
21/12/2024
Approval date [1] 316664 0
03/03/2025
Ethics approval number [1] 316664 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 138582 0
Dr Edward Gane
Address 138582 0
New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland, 1010, New Zealand
Country 138582 0
New Zealand
Phone 138582 0
+64 21548371
Fax 138582 0
Email 138582 0
[email protected]
Contact person for public queries
Name 138583 0
Sophie Chen
Address 138583 0
Vir Biotechnology, Inc. 1800 Owens Street, Suite 900, San Francisco, CA 94158, USA
Country 138583 0
United States of America
Phone 138583 0
+1 628 232 0317
Fax 138583 0
Email 138583 0
[email protected]
Contact person for scientific queries
Name 138584 0
Michael Chattergoon
Address 138584 0
Vir Biotechnology, Inc. 1800 Owens Street, Suite 900, San Francisco, CA 94158, USA
Country 138584 0
United States of America
Phone 138584 0
+1 215 868 8484
Fax 138584 0
Email 138584 0
[email protected]

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.