EUCTR2016-004625-16-FR进行中（未招募）1 期
A Phase 2, Open-label Study to Evaluate the Safety and Efficacy of Switching to Tenofovir Alafenamide (TAF) from Tenofovir Disoproxil Fumarate (TDF) and/or Other Oral Antiviral Treatment (OAV) in Virologically Suppressed Chronic Hepatitis B Subjects with Renal and/or Hepatic Impairment
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 120
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
- •Subjects must meet all of the following inclusion criteria to be eligible to participate in the study:
- •All Subjects (Parts A and B):
- •1) Must have the ability to understand and sign a written informed consent form; consent must be obtained prior to initiation of study procedures
- •2) Adult male or non-pregnant female subjects, = 18 years of age based on the date of the Screening visit. A negative serum pregnancy test at Screening is required for female subjects of childbearing potential
- •3) Documented evidence of chronic HBV infection (e.g. HBsAg positive for = 6 months)
- •4) Normal ECG (or if abnormal, determined by the Investigator not to be clinically significant)
- •5) ALT = 10 × upper limit of normal (ULN) at Screening by central laboratory
- •6) Must be willing and able to comply with all study requirements
- •Part A Only (renal impairment):
- •1) Maintained on TDF and/or other OAV treatment(s) for CHB for at least 48 weeks and with viral suppression (HBV DNA < LLOQ) for = 6 months prior to Screening
- •2) Moderate renal impairment (30 mL/min = eGFRCG = 59 mL/min), severe renal impairment (15 mL/min = eGFRCG < 30 mL/min) using the Cockcroft-Gault equation, or ESRD (eGFR < 15 mL/min) maintained on HD
- •Part B Only (hepatic impairment):
- •1) Maintained on TDF and/or other OAV(s) for CHB for at least 48 weeks and with viral suppression (HBV DNA < LLOQ) for = 6 months prior to Screening
- •2) CPT score (Appendix 7) of 7-12 (inclusive) OR a past history of CPT score = 7 and any CPT score = 12 at Screening
- •3) eGFRCG = 30 mL/min using the Cockcroft-Gault equation
- •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 84
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 36
排除标准
- •All Subjects (Parts A & B):
- •1) Pregnant women, women who are breastfeeding or who believe they may wish to become pregnant during the course of the study
- •2) Males and females of reproductive potential who are unwilling to use an effective”, protocol-specified method(s) of contraception during the study
- •3) Co-infection with HCV, HIV, or HDV
- •-Subjects who are HCV positive, but have a documented negative HCV RNA, are eligible
- •4) Prior Interferon (IFN) use within 6 months of Screening
- •5) Evidence of hepatocellular carcinoma (i.e. evidenced by imaging within 6 months of Screening)
- •6) Received solid organ or bone marrow transplant
- •7) Significant cardiovascular, pulmonary, or neurological disease in the opinion of the investigator
- •8) Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible
- •9) Currently receiving therapy with immunomodulators (e.g. corticosteroids), nephrotoxic agents, or agents capable of modifying renal excretion
- •10) Known hypersensitivity to study drugs, metabolites, or formulation excipients
- •11) Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
- •12) Any other clinical condition or prior therapy that, in the opinion of the Investigator, would make the subject unsuitable for the study or unable to comply with dosing requirements.
- •13) Use of investigational agents within 3 months of Screening, unless allowed by the Sponsor
- •14) Use of any prohibited medication
- •Part A Only (renal impairment):
- •1) Current or historical evidence of clinical hepatic decompensation (e.g., ascites, encephalopathy or variceal hemorrhage)
- •2) Abnormal hematological and biochemical parameters
- •3) Subjects with ESRD (i.e. eGFRCG < 15 mL/min) not on HD, or those on other forms of renal replacement therapy (i.e. peritoneal dialysis)
- •Part B Only (hepatic impairment):
- •1) Active variceal bleeding within 6 months or prior placement of a portosystemic shunt (such as transjugular intrahepatic portosystemic shunt [TIPS])
- •2) History of hepatorenal syndrome, hepatopulmonary syndrome, Grade 3 or Grade 4 hepatic encephalopathy, or spontaneous bacterial peritonitis within 6 months of Screening
- •3) Grade 2 hepatic encephalopathy at Screening
- •4) MELD score = 30
- •5) Abnormal hematological and biochemical parameters
研究者
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