None listed
Conditions
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.
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 injection
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.
Sponsors
Vir Biotechnology, Inc.
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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
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
Outcome results
None listed