EUCTR2021-001033-39-DE招募中1 期
A Phase 2 Study to Evaluate the Safety, Tolerability, and Efficacy of Regimens Containing VIR-2218, VIR-3434, and/or PEG-IFNa in Subjects with Chronic Hepatitis B Virus Infection
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 260
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 < 66 years
- •2. Body Mass Index (BMI) = 18 kg/m2 to = 35 kg/m2
- •3. Chronic HBV infection defined as a positive serum HBsAg, HBV DNA, or HBeAg on 2 occasions at least 6 months apart based on previous or
- •current laboratory documentation (any combination of these tests performed 6 months apart is acceptable)
- •4. On continuous NRTI therapy for at least 2 months prior to screening
- •5. HBV DNA < 100 IU/mL at screening
- •6. HBsAg > the lower limit of detection
- •7. Negative anti-HBs at screening
- •8. Besides chronic infection with HBV, must be in good health, determined from medical history, and no clinically significant findings from physical examination, vital signs, and laboratory values
- •9. Female subjects must have a negative pregnancy test or confirmation of postmenopausal status. Post-menopausal status is defined as 12 months with no menses without an alternative medical cause. Women of child-bearing 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 6.4) 14 days before study drug administration through 48 weeks after the last dose of study drug.
- •Female subjects must also agree to refrain from egg donation and in vitro fertilization from the time of study drug administration through 48
- •weeks after the last dose of study drug
- •10. Male subjects with female partners of child-bearing potential must agree to meet 1 of the following contraception requirements from the time of study drug administration through 48 weeks after the last dose of study drug: documentation of vasectomy or azoospermia, or male condom use plus partner use of 1 of the contraceptive options listed for contraception for WOCBP (Section 6.4).
- •Male subjects must also agree to not donate sperm from the time of first study drug administration through 48 weeks after the last dose of study
- •11. Willing to comply with the study requirements and able to provide written informed consent
- •12. Cohort 2b only: Previously enrolled in Cohort 1d of the VIR-2218-1001 study and completed the Treatment Period
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 365
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Significant fibrosis or cirrhosis as defined by having either a FibroScan result of > 8.5 kPa at screening or a liver biopsy within 1 year with Metavir F3 fibrosis or F4 cirrhosis.
- •2. History of clinically significant liver disease from non-HBV etiology
- •3. History of hepatic decompensation, including ascites, hepatic encephalopathy, and/or esophageal or gastric varices
- •4. History of immune complex disease
- •5. History of an autoimmune disorder
- •6. History of HBV-related extrahepatic disease, including but not limited to HBV-related rash, arthritis, or glomerulonephritis
- •7. History of allergic reactions hypersensitivity, or intolerance to monoclonal antibodies, antibody fragments or any excipients of VIR-3434
- •8. History of anaphylaxis
- •9. History of malignancy diagnosed or treated within 5 years (localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screening); subjects under evaluation for malignancy are not eligible.
- •10. History of bone marrow or solid organ transplant
- •11. Known active infection other than chronic HBV infection or any clinically significant acute condition such as fever (> 38? C) or acute respiratory illness within 7 days prior to Day 1
- •12. Co-infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (subjects with HDV) Subjects who are
- •HCV antibody or HDV antibody positive but have a documented negative HCV , RNA or HDV RNA, respectively, are eligble.
- •13. Creatinine clearance (CLcr) < 60 mL/min as calculated by the Cockcroft-Gault formula at screening
- •14. Subject has the following laboratory parameters at screening by laboratory testing:
- •a. ALT or aspartate aminotransferase (AST) > 3x ULN
- •b. direct bilirubin or INR > ULN
- •c. platelets < the lower limit of normal (LLN)
- •Screening laboratory tests may be repeated (eg, for values thought to be erroneous) with Sponsor medical monitor approval.
- •15. Regular consumption of more than 10 units of alcohol per week (1 unit = 1 glass of wine [125 mL] = 1 measure of spirits [30 mL] = one-half pint of beer [284 mL]), or more than 2 units of alcohol per day
- •16. History or clinical evidence of alcohol or drug abuse within the 12 months before screening or a positive drug screen at screening unless it can be explained by a prescribed
- •medication (the diagnosis and prescription must be approved by the investigator). Note: cannabis use is permitted
- •17. Use of any of the following systemic medications within 14 days before study drug
- •administration and throughout the study:
- •a. Paracetamol (acetaminophen) = 3 g/day
- •b. Isoniazid
- •c. Systemic steroids (prednisone equivalent of > 10 mg/day) or other immunosuppressive agents
- •d. Parts A, C and D only: theophylline
- •e. Parts A, C and D only: methadone
- •18. Received an investigational agent within 90 days or 5 half-lives (if known), whichever is
- •longer, before study drug administration or are active in the follow-up phase of another clinical study involving interventional treatment. Subjects 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 and NRTI Discontinuation Monitoring Period.
- •19. Receipt of an oligonucleotide (eg, siRNA, antisense oligonucleotide) with activity against HBV within 48 weeks before study drug administration
- •20. Receipt of VIR-2218 or VIR-3434 within 24 weeks prior to Day 1
- •21. Any clinic
研究者
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