NL-OMON53856招募中2 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
- 2 期
- 状态
- 招募中
- 入组人数
- 4
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
- 年龄范围
- 18 至 99（—）
入选标准
- •Age 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) and aspartate
- •aminotransferase (AST) > 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 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)
- •Cirrhotic * Liver biopsy with METAVIR F4 or Liver elastography (Fibroscan®) >=
- •12 kPa (Cohort 2) within the 12 months prior to screening * CLcr >= 60 mL/min as
- •calculated by the Cockcroft
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
研究者
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