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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06903338




Registration number
NCT06903338
Ethics application status
Date submitted
24/03/2025
Date registered
30/03/2025
Date last updated
8/07/2025

Titles & IDs
Public title
A Study to Evaluate Tobevibart + Elebsiran in Chronic HDV Infection
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] 0 0
VIR-CHDV-V203
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Viral Hepatitis 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Tobevibart
Treatment: Drugs - Elebsiran

Experimental: Arm 1 (Tobevibart + Elebsiran) - Participants will receive treatment with tobevibart + elebsiran for 240 weeks.

Experimental: Arm 2 (Tobevibart + Elebsiran) - Participants will receive tobevibart + elebsiran after an observational period for 240 weeks.


Treatment: Drugs: Tobevibart
Tobevibart administered by subcutaneous injection

Treatment: Drugs: Elebsiran
Elebsiran administered by subcutaneous injection
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HDV RNA < Lower Limit of Quantification (LLOQ), Target Not Detected (TND) and alanine aminotransferase (ALT) normalization (ALT
Timepoint [1] 0 0
Up to 48 weeks
Primary outcome [2] 0 0
Incidence of Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) through Week 12
Timepoint [2] 0 0
Up to 12 weeks
Secondary outcome [1] 0 0
HDV RNA < LLOQ, TND at Week 48 for Arm 1 vs Week 12 for Arm 2
Timepoint [1] 0 0
Up to 48 weeks

Eligibility
Key inclusion criteria
1. Male or female ages 18 to 70 years at screening
2. Chronic HDV infection for >/= 6 months
3. On NRTI therapy against HBV for at least 12 weeks prior to day 1 or have HBV DNA < 20 IU/ml at screening, currently on locally approved NRTI therapy
4. Serum ALT > ULN and < 5x ULN
5. Non-cirrhotic or Compensated Cirrhotic Liver Disease at screening
Minimum age
18 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Any clinically significant chronic or acute medical or psychiatric condition that makes the participant unsuitable for participation.
2. History of significant liver disease from non-HBV or non-HDV etiology
3. History of allergic reactions, hypersensitivity, or intolerance to study drug, its metabolites, or excipients.
4. History of anaphylaxis
5. History of immune complex disease
6. History of autoimmune disorder
7. History or evidence of alcohol or drug abuse within 6 months before screening or a positive drug screen at screening unless it can be explained by a prescribed medication

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



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

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/03/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/05/2031
Actual
Sample size
Target
120
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Maryland
Country [4] 0 0
United States of America
State/province [4] 0 0
New Jersey
Country [5] 0 0
United States of America
State/province [5] 0 0
Utah
Country [6] 0 0
United States of America
State/province [6] 0 0
Washington
Country [7] 0 0
Canada
State/province [7] 0 0
Alberta
Country [8] 0 0
Canada
State/province [8] 0 0
Quebec
Country [9] 0 0
Georgia
State/province [9] 0 0
Tbilisi
Country [10] 0 0
Moldova, Republic of
State/province [10] 0 0
Chisinau
Country [11] 0 0
New Zealand
State/province [11] 0 0
Auckland
Country [12] 0 0
Romania
State/province [12] 0 0
Bucuresti
Country [13] 0 0
Ukraine
State/province [13] 0 0
Kyiv
Country [14] 0 0
United Kingdom
State/province [14] 0 0
London

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Vir Biotechnology, Inc.
Address
Country

Ethics approval
Ethics application status

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

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Study Inquiry
Address 0 0
Country 0 0
Phone 0 0
415-654-5281
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06903338