ACTRN12620000403932招募中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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 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
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 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 greater than 3 months prior to the screening visit available for review.
- •5. Have been receiving entecavir and/or tenofovir (including tenofovir alafenamide) for
- •greater than or equal to 12 months prior to screening and are willing to continue.
- •6. HBV DNA negative at screening.
- •7. Quantitative HBV surface antigen less than or equal to 1000 IU/mL at the screening visit. Participants with HBsAg levels greater than or equal to 1000 IU/mL and less than or equal to 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:
- •9. a. Liver biopsy demonstrating a Metavir Fibrosis Score of F0-2 (or equivalent);
- •b. Fibroscan® result of less than 9 kPa.
- •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 6 months after the final dose of the study intervention.
- •11. Capable of giving signed informed consent.
排除标准
- •Participants are excluded from the study if ANY of the following criteria apply:
- •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 less than or equal to 3 years prior to the screening visit (except adequately treated carcinoma in situ and basal cell carcinoma of the skin).
- •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.
研究者
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