BridgeMD
A Study to Evaluate Investigational Therapies in Chronic Hepatitis D Virus Infection.
EU CTIS ID: 2024-512203-40-00
What this study is testing
1. To evaluate the efficacy of VIR-2218 and VIR-3434 in participants with chronic HDV infection in Cohorts 2 and 3 only. 2. Treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs)
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 1. Age ≥ 18 (or age of legal consent, whichever is older) to < 70 years at the time of screening Type of Participant and Disease Characteristics 2. Chronic HBV infection defined as a positive serum HBsAg, HBV DNA, or HBeAg on 2 occasions at least 6 months apart based on previous (within the past 12 months) or current laboratory documentation (any combination of these tests performed 6 months apart is acceptable) 3. On locally approved NRTI therapy for at least 12 weeks prior to Day 1 4. HBsAg > 0.05 IU/mL at screening 5. Positive HDV antibody for at least 6 months prior to screening and HDV RNA ≥ 500 IU/mL at screening 6. Serum alanine aminotransferase (ALT) > ULN and < 5 x ULN Weight 7. Body Mass Index (BMI) ≥ 18 kg/m2 to ≤ 40 kg/m2 Sex and Contraceptive/Barrier Requirements 8. Female participants must have a negative pregnancy test or confirmation of postmenopausal status. Postmenopausal status is defined as 12 months with no menses without an alternative medical cause (see Section 10.7 for additional details). Women of childbearing potential (WOCBP) must have a negative blood pregnancy test at screening and a negative urine pregnancy test on Day 1, cannot be breast feeding, and must be willing to use highly effective methods of contraception (Section 10.7) 14 days before study intervention administration through 48 weeks after the last dose of VIR-2218 or VIR-3434. Female participants must also agree to refrain from egg donation and in vitro fertilization from the time of study intervention administration through 24 weeks after the last dose of VIR-2218 or VIR-3434. 9. Male participants with female partners of childbearing potential must agree to meet 1 of the following contraception requirements from the time of study intervention administration through 24 weeks after the last dose of VIR-2218 or VIR-3434: documentation of vasectomy or azoospermia, or male condom use plus partner use of 1 of the contraceptive options listed for contraception for WOCBP (Section 10.7). Male participants must also agree to not donate sperm from the time of first study intervention administration through 24 weeks after the last dose of VIR-2218 or VIR-3434. Informed Consent 10. Capable of giving signed informed consent as described in Section 10.1.3, which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol For the rest of the inclusion criteria, please refer to the study protocol.
You likely can't join if
- Medical Conditions 1. History of clinically significant liver disease from non-HBV and non- HDV etiology as determined by the investigator 2. History of clinically significant immune complex disease as determined by the investigator 3. History of clinically significant autoimmune disorder as determined by the investigator 4. History of HBV-related extrahepatic disease, including but not limited to HBV-related rash, arthritis, or glomerulonephritis 5. History of allergic reactions, hypersensitivity, or intolerance to study intervention, its metabolites or excipients 6. Anti-HBs >10 mIU/L at screening 7. Corrected QT interval (QTc) > 450 milliseconds 8. ALT or AST ≥ 5 x ULN 9. Total bilirubin > 2.0 mg/dL 10. Serum albumin < 30 g/L 11. Absolute neutrophil count < 1,000/mm3 (/μL) 12. International normalized ratio (INR) > 1.5 13. Hemoglobin < 8 g/dL 14. History of anaphylaxis 15. History of malignancy diagnosed or treated within 5 years (localized treatment of squamous or noninvasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); participants under evaluation for malignancy are not eligible 16. History of or listed for bone marrow or solid organ transplant 17. Known active infection other than chronic HBV and HDV infection or any clinically significant acute condition such as fever (> 38° C) or acute respiratory illness within 7 days prior to Day 1 18. Coinfection with human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis C virus (HCV) or hepatitis E virus (HEV). Participants who are HCV antibody positive and HCV RNA negative are eligible. Participants who are HAV or HEV immunoglobulin M antibody (IgM) positive can be enrolled if asymptomatic and HAV or HEV immunoglobulin G antibody (IgG) positive. 19. Any clinically significant medical or psychiatric condition that may interfere with study intervention, assessment, or compliance with the protocol or otherwise makes the participant unsuitable for participation in the study, as determined by the investigator. Participants with controlled Diabetes Mellitus are eligible. 20. Acute or worsening chronic hepatitis, fluctuating or rapidly deteriorating hepatic function or use of any therapy known to exacerbate hepatic dysfunction in the opinion of the investigator. For the rest of the exclusion criteria, please refer to the study protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Moldova, Republic of
- New Zealand
- United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Moldova, Republic of; New Zealand; United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.