EUCTR2022-001993-78-BG招募中1 期
A Phase 2 Study to Evaluate Efficacy, Safety and Tolerability of VIR-2218 and VIR-3434 in Participants with Chronic Hepatitis D Virus Infection (SOLSTICE) - SOLSTICE
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 124
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •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
- •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 48 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 48 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 48 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
- •Other Inclusion Criteria
- •11. 12-lead electrocardiogram (ECG) within normal limits; or, with no clinically significant abnormalities at screening, as determined by the investigator.
- •12. Agrees not to donate blood during the duration of the study and for an additional 3 months after the last dose of study intervention.
- •Cohort Specific Inclusion Criteria
- •13. Cohort 1 specific inclusion criteria
- •Noncirrhotic
- •- Liver biopsy with METAVIR F0-F3 or Liver elastography (eg, Fibroscan®)
- •< 12 kilopascal (kPa) within the 12 months prior to screening
- •- Creatinine clearance (CLcr) = 30 mL/min as calculated by the Cockcroft-Gault formula at screening
- •- Platelet count > 150,000 cells/mm3 (/µL)
- •14. Cohorts 2a, 2b1, 2b2, 2c, 3 & 4 specific inclusion criteria
- •Noncirrhotic
- •-Liver biopsy with METAVIR F0-F3 or Liver elastography (eg, Fibroscan®) < 12 kPa within the 12 months prior to screening
- •-CLcr = 30 mL/min as calculated by the Cockcroft-Gault formula at screening
- •-Platelet count > 150,000 cells/mm3 (/µL)
- •CPT-A Cirrhotic
- •-Liver biopsy with METAVIR F4 or Liver elastography (eg
排除标准
- •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 = 5x 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 are not eligible. Participants who are asymptomatic and HAV or HEV immunoglobulin G antibody (IgG) positive are eligible.
- •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.
- •Prior/Concomitant Therapy
- •21. Therapy with an immunomodulatory agent, IFN-a (eg, IFN-alfa-2a or IFN-alfa-2b, or pegylated IFN-alfa-2a or alfa 2b), immunosuppressants (eg, disease-modifying antirheumatic drugs), cytotoxic or chemotherapeutic agent, or chronic systemic corticosteroids within 6 months of screening.
- •22. Received an HDV active agent (including lonafarnib and bulevirtide) within 90 days or 5 half-lives (if known), whichever is longer, before study drug administration or are active in the Follow-Up period of another clinical study involving interventional treatment. Participants must also agree not to take part in any other interventional study at any time during their participation in this study, inclusive of the Follow-Up Period.
- •23. Receipt of an oligonucleotide (eg, siRNA, antisense oligonucleotide) with activity against HBV within 48 weeks before study drug administration
- •24. Receipt of VIR-3434 or any antibody targeting HBV or HDV within 24 weeks of first study drug administration
- •Additional Exclusions
- •25. History or clinical evidence of alcohol or drug abuse within the 12 months before screening
研究者
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