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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)
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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)
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Secondary ID [1]
313583
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EU CT: 2024-515919-22-00
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Secondary ID [2]
313541
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Protocol number: VIR-CHDV-V203
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Universal Trial Number (UTN)
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Trial acronym
ECLIPSE 1
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Chronic Hepatitis Delta Virus (HDV) Infection
336113
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Condition category
Condition code
Infection
332665
332665
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0
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Other infectious diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
330177
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Treatment: Drugs
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Comparator / control treatment
Delayed treatment in Arm 2.
The control group will be offered the intervention in Week 12.
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Control group
Active
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Outcomes
Primary outcome [1]
340180
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To evaluate the efficacy of tobevibart+elebsiran compared with delayed treatment in participants with chronic HDV infection
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Assessment method [1]
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Hepatitis Delta Virus Ribonucleic Acid (HDV RNA) below the Lower Limit of Quantification (LLOQ), Target Not Detected (TND) and Alanine Transaminase (ALT) normalization (ALT less than or equal to Upper Limit of Normal (ULN)). ALT is measured by blood tests. HDV RNA is measured by Nucleic Acid Amplification Test (NAAT). This will be a composite assessment.
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Timepoint [1]
340180
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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)
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Primary outcome [2]
340181
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To evaluate the safety of tobevibart+elebsiran in participants with chronic HDV infection
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Assessment method [2]
340181
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Incidence of Treatment Emergent Adverse Event (TEAEs) and Serious Adverse Event (SAEs). The TEAE summary table will combine all TEAE, serious or not. This will be a composite assessment. The severity of adverse events will be assessed according to the standard toxicity grading in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, or later.
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Timepoint [2]
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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).
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Secondary outcome [1]
445151
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To evaluate the antiviral effect of tobevibart+elebsiran on HDV viremia compared with delayed treatment in participants with chronic HDV infection
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Assessment method [1]
445151
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Change from baseline in HDV RNA Assessment methods will be blood tests and HDV RNA by Nucleic Acid Amplification Test (NAAT).
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Timepoint [1]
445151
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At Week 48 of treatment for Arm 1 vs at Week 12 of treatment for Arm 2
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Secondary outcome [2]
445158
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To evaluate the long-term efficacy of tobevibart+elebsiran in participants with chronic HDV infection
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Assessment method [2]
445158
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HDV RNA below the LLOQ and ALT less than or equal to ULN Assessment methods will be blood tests and HDV RNA by Nucleic Acid Amplification Test (NAAT).
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Timepoint [2]
445158
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At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
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Secondary outcome [3]
445154
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To evaluate the impact of tobevibart+elebsiran on ALT compared with delayed treatment in participants with chronic HDV infection
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Assessment method [3]
445154
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ALT less than 1.25 x ULN Assessment methods will be blood tests.
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Timepoint [3]
445154
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At Week 48 of treatment for Arm 1 vs at Week 12 of treatment for Arm 2
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Secondary outcome [4]
445150
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To evaluate the antiviral effect of tobevibart+elebsiran on HDV viremia compared with delayed treatment in participants with chronic HDV infection
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Assessment method [4]
445150
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HDV RNA below the LLOQ Assessment methods will be blood tests and HDV RNA by Nucleic Acid Amplification Test (NAAT).
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Timepoint [4]
445150
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At Week 48 of treatment for Arm 1 vs at Week 12 of treatment for Arm 2
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Secondary outcome [5]
443184
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To evaluate the efficacy of tobevibart+elebsiran compared with delayed treatment in participants with chronic HDV infection
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Assessment method [5]
443184
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HDV RNA below the LLOQ, TND and ALT less than 1.25 × ULN ALT is measured by blood tests and HDV RNA by Nucleic Acid Amplification Test (NAAT). This will be a composite assessment.
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Timepoint [5]
443184
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At Week 48 for Arm 1 vs at Week 12 for Arm 2
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Secondary outcome [6]
443188
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To evaluate the long-term impact of tobevibart+elebsiran on liver stiffness in participants with chronic HDV infection
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Assessment method [6]
443188
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Change from baseline in liver stiffness as measured by liver elastography
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Timepoint [6]
443188
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At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
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Secondary outcome [7]
443186
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To evaluate the long-term antiviral effect of tobevibart+elebsiran on HDV viremia in participants with chronic HDV infection
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Assessment method [7]
443186
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HDV RNA below the LLOQ, TND Assessment methods will be blood tests and HDV RNA by Nucleic Acid Amplification Test (NAAT).
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Timepoint [7]
443186
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At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
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Secondary outcome [8]
445156
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To evaluate the impact of tobevibart+elebsiran on ALT compared with delayed treatment in participants with chronic HDV infection
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Assessment method [8]
445156
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Change from baseline in ALT Assessment methods will be blood tests.
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Timepoint [8]
445156
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At Week 48 of treatment for Arm 1 vs at Week 12 of treatment for Arm 2
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Secondary outcome [9]
443183
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To evaluate the impact of tobevibart+elebsiran on ALT compared with delayed treatment in participants with chronic HDV infection
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Assessment method [9]
443183
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ALT less than or equal to ULN Assessment methods will be blood tests.
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Timepoint [9]
443183
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At Week 48 for Arm 1 vs at Week 12 for Arm 2
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Secondary outcome [10]
443185
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To evaluate the long-term efficacy of tobevibart+elebsiran in participants with chronic HDV infection
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Assessment method [10]
443185
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HDV RNA below the LLOQ, TND and ALT less than or equal to ULN Assessment methods will be blood tests and HDV RNA by Nucleic Acid Amplification Test (NAAT). This will be a composite assessment.
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Timepoint [10]
443185
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At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
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Secondary outcome [11]
443187
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To evaluate the long-term impact of tobevibart+elebsiran on ALT in participants with chronic HDV infection
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Assessment method [11]
443187
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ALT less than or equal to ULN Assessment methods will be blood tests.
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Timepoint [11]
443187
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At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
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Secondary outcome [12]
445162
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To evaluate the long-term impact of tobevibart+elebsiran on ALT in participants with chronic HDV infection
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Assessment method [12]
445162
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ALT less than 1.25 x ULN Assessment methods will be blood tests.
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Timepoint [12]
445162
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At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
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Secondary outcome [13]
443182
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To evaluate the antiviral effect of tobevibart+elebsiran on HDV viremia compared with delayed treatment in participants with chronic HDV infection
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Assessment method [13]
443182
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HDV RNA below the LLOQ, TND Assessment methods will be blood tests and HDV RNA by Nucleic Acid Amplification Test (NAAT).
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Timepoint [13]
443182
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At Week 48 for Arm 1 vs at Week 12 for Arm 2
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Secondary outcome [14]
445160
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To evaluate the long-term antiviral effect of tobevibart+elebsiran on HDV viremia in participants with chronic HDV infection
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Assessment method [14]
445160
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HDV RNA below the LLOQ Assessment methods will be blood tests and HDV RNA by Nucleic Acid Amplification Test (NAAT).
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Timepoint [14]
445160
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At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
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Secondary outcome [15]
445159
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To evaluate the long-term efficacy of tobevibart+elebsiran in participants with chronic HDV infection
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Assessment method [15]
445159
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HDV RNA below the LLOQ, TND and ALT less than 1.25 x ULN Assessment methods will be blood tests and HDV RNA by Nucleic Acid Amplification Test (NAAT).
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Timepoint [15]
445159
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At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
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Secondary outcome [16]
445197
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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
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Assessment method [16]
445197
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SAE reporting to be reported by the Investigator via study specific form by email or fax within 24 hours
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Timepoint [16]
445197
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By 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
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Secondary outcome [17]
445161
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To evaluate the long-term antiviral effect of tobevibart+elebsiran on HDV viremia in participants with chronic HDV infection
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Assessment method [17]
445161
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Change from baseline in HDV RNA Assessment methods will be blood tests and HDV RNA by Nucleic Acid Amplification Test (NAAT).
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Timepoint [17]
445161
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At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
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Secondary outcome [18]
443190
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To evaluate the safety of tobevibart+elebsiran in participants with chronic HDV infection
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Assessment method [18]
443190
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Incidence of TEAEs and SAEs. The TEAE summary table will combine all TEAE, serious or not. This will be a composite assessment. The severity of adverse events will be assessed according to the standard toxicity grading in the Common Terminology Criteria for Adverse Events (CTCAE) v5.0, or later.
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Timepoint [18]
443190
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Through 48, 96, 144, 192 and 240 weeks of treatment.
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Secondary outcome [19]
445163
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To evaluate the long-term impact of tobevibart+elebsiran on ALT in participants with chronic HDV infection
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Assessment method [19]
445163
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Change from baseline in ALT Assessment methods will be blood tests.
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Timepoint [19]
445163
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At 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
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Secondary outcome [20]
445196
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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
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Assessment method [20]
445196
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Incidence of decompensated cirrhosis (clinical event or Child-Turcotte-Pugh (CPT) score greater than or equal to 7). Incidence of decompensated cirrhosis (clinical event reported as AEs/SAEs.
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Timepoint [20]
445196
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By 48, 96, 144, 192 and 240 weeks of tobevibart+elebsiran treatment
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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
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Minimum age
18
Years
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Maximum age
70
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Central randomisation by computer
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Permuted block randomisation
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Masking / blinding
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Who is / are masked / blinded?
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Intervention assignment
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Not yet recruiting
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Date of first participant enrolment
Anticipated
29/05/2025
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Actual
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
120
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Accrual to date
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Final
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Recruitment outside Australia
Country [1]
26790
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New Zealand
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State/province [1]
26790
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Funding & Sponsors
Funding source category [1]
318003
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Commercial sector/Industry
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Name [1]
318003
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Vir Biotechnology, Inc.
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Address [1]
318003
0
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Country [1]
318003
0
United States of America
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Primary sponsor type
Commercial sector/Industry
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Name
Vir Biotechnology, Inc.
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Address
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Country
United States of America
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Secondary sponsor category [1]
320415
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None
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Name [1]
320415
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Address [1]
320415
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Country [1]
320415
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
316664
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Central Health and Disability Ethics Committee
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Ethics committee address [1]
316664
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https://ethics.health.govt.nz/about/central-health-and-disability-ethics-committee/
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Ethics committee country [1]
316664
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New Zealand
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Date submitted for ethics approval [1]
316664
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21/12/2024
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Approval date [1]
316664
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03/03/2025
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Ethics approval number [1]
316664
0
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Summary
Brief summary
This is a phase 3, prospective, multicentre, randomized, open-label study that is evaluating the efficacy and safety of immediate treatment of tobevibart and elebsiran (combination treatment) compared with delayed combination treatment in noncirrhotic and cirrhotic participants with chronic HDV infection who are on NRTI therapy (nucleos(t)ide analogues) against HBV. The trial will test whether tobevibart + elebsiran can lower levels of HDV in the blood and return liver enzyme levels to normal in participants with chronic HDV infection. The safety of tobevibart + elebsiran will also be studied.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
138582
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Dr Edward Gane
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Address
138582
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New Zealand Clinical Research, 3 Ferncroft Street, Grafton, Auckland, 1010, New Zealand
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Country
138582
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New Zealand
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Phone
138582
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+64 21548371
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Fax
138582
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Email
138582
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[email protected]
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Contact person for public queries
Name
138583
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Sophie Chen
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Address
138583
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Vir Biotechnology, Inc. 1800 Owens Street, Suite 900, San Francisco, CA 94158, USA
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Country
138583
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United States of America
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Phone
138583
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+1 628 232 0317
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Fax
138583
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Email
138583
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[email protected]
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Contact person for scientific queries
Name
138584
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Michael Chattergoon
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Address
138584
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Vir Biotechnology, Inc. 1800 Owens Street, Suite 900, San Francisco, CA 94158, USA
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Country
138584
0
United States of America
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Phone
138584
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+1 215 868 8484
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Fax
138584
0
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Email
138584
0
[email protected]
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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.
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