EUCTR2019-004212-64-RO进行中（未招募）1 期
An Open-label Study Evaluating the Safety, Antiviral Activity, and Pharmacokinetics of IMC-I109V in HLA-A*02:01 Positive Patients with Chronic HBV who are Non-Cirrhotic, Hepatitis B e Antigen-negative, and Virally Suppressed - IMC-I109V-101
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Aged 18 to 55 years inclusive, at the time of signing the informed consent.
- •2. HLA-A*02:01 positive (central laboratory testing)
- •3. Documented evidence of CHB based on one of the following:
- •a. Positive HBsAg and HBV DNA at least 6 months prior to the screening visit; OR
- •b. Historical liver biopsy consistent with CHB infection available.
- •4. If previously HBeAg-positive, participants must be HBeAg-negative at the screening visit and have historical HBeAg-negative status >3 months prior to the screening visit available for review.
- •5. Have been receiving entecavir and/or tenofovir (including tenofovir alafenamide) for = 12 months prior to screening and are willing to continue.
- •6. HBV DNA negative (below the LLOQ) at screening
- •7. Quantitative HBV surface antigen = 1000 IU/mL at the screening visit. Participants with HBsAg levels = 1000 IU/mL and = 3000 IU/mL may be eligible after consultation with, and approval by, the Sponsor’s Medical Monitor.
- •8. All participants must have no history of liver cirrhosis AND prior assessment of fibrosis demonstrating non-cirrhotic status at screening as defined by one of the following:
- •a. Liver biopsy demonstrating a Metavir Fibrosis Score of F0-2 (or equivalent); OR
- •b. Fibroscan® result of < 9 kPa.
- •NOTE: A confirmatory Fibroscan® is required within 6 months prior to Day 1.
- •9. Liver imaging confirming absence of clinically significant abnormalities is required within 6 months prior to Day 1.
- •10. Male and female participants of childbearing potential who are sexually active with a nonsterilized partner must agree to use highly effective methods of birth control from the trial screening date until 3 months after the final dose of the study intervention or longer if required by local regulations; cessation of birth control after this point should be discussed with a responsible physician. *Male participants are not allowed to donate sperm from the time of enrollment until 3 months post-administration of study interventions or longer if required by local regulations.
- •*Female participants must refrain from egg donation during the course of the study
- •11. Capable of giving signed informed consent
- •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 80
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Medical Conditions
- •1. Known co-infection with any of the following:
- •b. Hepatitis C virus OR
- •c. Hepatitis D virus
- •2. Changes in HBeAg status within 3 months prior to the screening visit
- •3. Known HBV genotype A
- •4. History of HCC
- •5. Gilbert’s syndrome
- •6. Any known pre-existing medical or psychiatric condition that could interfere with the participant’s ability to provide informed consent or participate in study conduct, or that may confound study findings
- •7. Significant immunosuppression from, but not limited to immunodeficiency conditions
- •such as common variable hypogammaglobulinemia
- •8. Evidence of active or suspected malignancy, or a history of malignancy = 3 years prior to
- •the screening visit (except adequately treated carcinoma in situ and basal cell carcinoma
- •of the skin). NOTE: Participants under evaluation for malignancy are not eligible
- •9. Known or suspected hypersensitivity or previous severe reactions to any of the constituents of IMC-I109V, or the drugs used in the pre-treatment regimen (eg, dexamethasone, ibuprofen and paracetamol)
- •10. Pregnant or lactating women
- •Prior/Concomitant Therapy
- •11. Receiving or planning to receive systemic immunosuppressive medications during the study or = 2 months prior to Day 1, including but not limited to prednisone > 10 mg/day (or equivalent), methotrexate, cyclosporine, or interferon. NOTE: Local steroid therapy are allowed (eg, inhaled, otic, ophthalmic, or intra-articular medications).
- •Prior/Concurrent Clinical Study Experience
- •12. Use of any live vaccines against infectious diseases within 4 weeks of the first planned administration of study intervention or use of any non-live vaccines against infectious diseases within 2 weeks of the first planned administration of study intervention.
- •13. Treatment with any investigational drug or enrollment in any other clinical study = 6 months prior to Day 1, or at any time during participation in the study
- •Laboratory Exclusion Criteria
- •14. If any of the laboratory exclusion criteria are met, then the site may have the participant retested. If a single value is within ±10% of the listed laboratory exclusion criterion value upon retest, and the value is considered to be not clinically significant by the physician investigator, the participant may be considered for enrollment.
- •Other Exclusions
- •15. Clinical diagnosis of substance abuse with alcohol, narcotics, or cocaine = 12 months prior to the screening visit, except for those participants monitored in an opioid substitution maintenance program
- •16. Poor venous access that precludes routine peripheral blood sampling or intravenous (IV) infusion required for this study
- •17. Participants who have a planned need for anesthesia for outpatient surgery or any other reasons during the study
- •18. Employed as site personnel directly involved with this study
研究者
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