ACTRN12624000808549尚未招募1 期
A Phase 1b Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Cavrotolimod Alone and in Combinations in Subjects with Chronic Hepatitis B Infection
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 40
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
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •1. Male or female adults between 18 and 65 years of age, inclusive
- •2. Chronic HBV infection greater than or equal to 6 months (e.g., positive for serum HBsAg greater than or equal to 6 months)
- •3. Taking a commercially available nucleos(t)ide analogs for at least 2 months prior to Screening, and willing to remain on stable treatment for the duration of the study, unless they achieve nucleos(t)ide stopping criteria.
- •4. HBV DNA less than 100 IU/mL in blood at Screening
- •5. HBsAg at Screening:
- •a. Part A: greater than LLOQ
排除标准
- •1. Pregnant or nursing females
- •2. Male or female subjects of childbearing potential unwilling to comply with contraception requirements during the study
- •3. Fibroscan greater than or equal to 8.5 kPa within 1 year of Screening
- •4. History of and/or current decompensated liver disease as evidenced by ascites, hepatic encephalopathy, and/or gastric or esophageal variceal bleeding
- •5. Presence of liver disease, not including chronic HBV infection, such as nonalcoholic steatohepatitis (NASH), alcohol-associated hepatitis, cholestatic liver disease, other viral (e.g., HCV or HDV) or non-viral hepatitis that has the potential to impact interpretation
- •of data. Exceptions to this criterion include fatty liver without any signs of steatohepatitis or past HCV infection that was successfully treated greater than or equal to 6 months prior to Screening.
- •6. Positive for HIV, HDV, or HCV infection at Screening
- •7. Received solid organ or bone marrow transplant
- •8. Chronic systemic immunosuppressive therapy (e.g., prednisone) within 1 month of Screening or require the use of during the study.
- •9. Prior or current history of hepatocellular carcinoma (HCC) or suspected HCC as evidenced by screening alpha-fetoprotein greater than or equal to 20 ng/mL
- •10. History of hypersensitivity to any of the components in the cavrotolimod formulation or severe reactions to injections
- •11. Screening laboratory results as follows, or any other clinically significant abnormalities in screening laboratory values that would render a subject unsuitable for inclusion:
- •a. Presence of anti-thyroid antibodies (anti-thyroid-stimulating hormone receptor [TSHR], anti-thyroglobulin [TG], or anti- thyroid peroxidase [TPO])
- •b. Abnormal thyroid stimulating hormone (TSH)
- •c. ANA greater than 1:160
- •d. ALT or aspartate aminotransferase (AST) greater than 2× upper limit of normal (ULN)
- •e. Total bilirubin greater than 1.2× ULN, except for subjects with Gilbert’s (normal direct bilirubin)
- •f. Serum albumin less than .5 g/dL
- •g. International normalized ratio (INR) greater than 1.2
- •h. Platelet count less than 140 K/mm3
- •i. Hemoglobin less than 12.0 g/dL for males and <11.0 g/dL for females
- •j. Absolute neutrophil count less than 1000/mm3
- •k. Estimated glomerular filtration rate lass than 50 mL/min/1.73 m2 by Cockcroft-Gualt
- •12. 12-lead electrocardiogram (ECG) showing the following: having a corrected QTc interval greater than 450 msec for males and greater than 470 msec for females or <340 msec (Fridericia’s correction)
- •13. Clinically significant medical history of:
- •a. Cardiac diseases (e.g., myocardial infarctions, stroke, arrhythmia, heart failure, and coronary heart disease),
- •b. Autoimmune diseases (e.g., lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, sarcoidosis, moderate or severe psoriasis, thyroiditis), or
- •c. Malignancies within 3 years. Malignancy that has been successfully surgically resection and considered cured would not exclude the subject.
- •14. Treatment with an investigational drug, biological agent or device within 4 weeks or 5 half-lives prior to Screening, whichever is longer.
- •15. History of excess alcohol consumption within 1 year of Screening, defined as weekly intake of greater than or equal to 14 drinks per week (average of greater than or equal to 2 drinks per day)
- •16. History of drug abuse/addiction within 6 months of Screening (except cannabis)
- •17. Have any other conditions (medical, social, psychiatric, or other)
研究者
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