A Study to Evaluate Tobevibart+Elebsiran in Chronic Hepatitis Delta Virus (HDV) Infection (ECLIPSE 1)
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)
Vir Biotechnology, Inc.
120 participants
Mar 12, 2025
Interventional
Conditions
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.
Eligibility
Inclusion Criteria6
- Adult men and women aged greater than or equal to 18 years (or age of legal consent, whichever is older) to less than or equal to 70 years at the time of signing informed consent.
- Positive HDV antibody or positive HDV RNA PCR result for at least 6 months prior to screening and HDV RNA greater than or equal to 500 IU/mL at screening.
- Noncirrhotic or compensated cirrhotic liver disease at screening.
- Serum alanine aminotransferase (ALT) greater than ULN and less than 5 x ULN
- Body mass index (BMI) greater than or equal to 18 kg/m2 to less than or equal to 40 kg/m2
- On NRTI therapy against HBV for at least 12 weeks prior to Day 1 or have HBV DNA less than 10 IU/ml at screening, and currently on one of the following NRTI therapies: tenofovir alafenamide, tenofovir disoproxil fumarate, or entecavir
Exclusion Criteria13
- 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)
- 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).
- History of clinically significant immune complex disease as determined by the Investigator.
- History of anaphylaxis, allergic reactions, hypersensitivity, or intolerance to study drug, study drug component (ex. Oligonucleotide and/or GalNAc), its metabolites or excipients
- Participants with active HCV (participants with HCV antibodies can be enrolled if screening HCV RNA PCR test is negative).
- Participants with uncontrolled HIV-1 infection (defined as HIV-1 RNA PCR value above the lower limit of assay detection with CD4+ T-cell counts below 500/mm3 within the last 12 months) or any HIV-2 infection.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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.
Locations(10)
View Full Details on ANZCTR
For the most up-to-date information, visit the official listing.
ACTRN12625000416493