ACTRN12619000271101招募中1 期
An Observer-blind, Randomized Study with an Open-label Part to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Administration of RO7191863 with Multiple Doses and Different Regimens in Virologically Suppressed Patients with Chronic Hepatitis B Infection
F. Hoffmann-La Roche0 个研究点目标入组 49 人开始时间: 2019年2月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 发起方
- 入组人数
- 49
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
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Participants are eligible to be included in the study only if all of the following criteria apply:
- •Informed Consent
- •1. Able and willing to provide written informed consent and to comply with the study protocol according to ICH and local regulations.
- •2. Participant must be between 18 to 65 years (inclusive) at the time of signing the informed consent.
- •3. Body weight of < 150 kg, and body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive).
- •4. Male and female participants agree to protocol defined methods of contraception.
- •Type of Participants and Disease Characteristics
- •5. Positive serum HBsAg status for > 6 months.
- •6. Serum HBsAg level >= 250 IU/mL.
- •7. On stable entecavir or tenofovir (alone or in combination) treatment, and having received the same NUC in the 3 months prior to Randomization.
- •8. HBV DNA below the lower limit of quantification (LLQ) for > or equals to 6 months prior to Screening by local testing, and confirmed at Screening.
- •9. No current diagnosis of significant liver fibrosis or cirrhosis (F3 or above). No history of cirrhosis. A past F3 staging that has regressed to < F3 on NUC therapy is acceptable for inclusion.
- •10. Transient elastography showing a level of liver stiffness not indicative of significant liver fibrosis.
- •11. Screening laboratory values within normal ranges, or judged to be not clinically significant by the Investigator.
- •12. Negative test results for anti-nuclear antibodies, anti-mitochondrial antibodies, anti-smooth muscle antibodies, anti-thyroperoxidase and anti-platelet antibodies.
排除标准
- •1. History or presence of significant cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, haematological disorders, or diagnosed central or peripheral neurological disease, capable of altering the absorption, metabolism, or elimination of drugs, of constituting a risk when taking the study treatment, or of interfering with the interpretation of the data.
- •2. Personal or familial history or symptomatology indicative of a risk of immune-mediated disease. Personal history of thyroid disease.
- •3. History or presence of bridging fibrosis or cirrhosis or decompensated liver disease.
- •4. History or presence of a medical condition associated with liver disease other than HBV infection. Other known hepatic or biliary abnormalities.
- •5. History of or suspicion of hepatocellular carcinoma.
- •6. History of lymphoma, leukaemia, or malignancy within the past five years.
- •7. History of having received or currently receiving any systemic anti-neoplastic or immune-modulatory treatment.
- •8. History of organ transplantation.
- •9. Estimated glomerular filtration rate (eGFR) < 70 mL/min/1.73m^2.
- •10. Expected to need any other systemic antiviral therapy at any time during participation in the study.
- •11. Positive hepatitis D virus (HDV) or hepatitis C virus (HCV) antibody test result.
- •12. Positive for HIV infection at Screening.
研究者
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