ACTRN12616000898459进行中（未招募）2 期
A Phase 2, Randomized, Open Label Study to Evaluate the Efficacy and Safety of Tenofovir Alafenamide (TAF) versus Tenofovir Disoproxil Fumarate (TDF)–containing Regimens inSubjects with Chronic HBV Infection and Stage 2 or Greater Chronic Kidney Disease Who Have Received a Liver Transplant
适应症
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 50
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
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 o limit（—）
- 性别
- All
入选标准
- •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, over 18 years of age based on the date of the screening visit
- •3) Documented evidence of chronic HBV infection prior to transplantation
- •4) Primary or secondary (re-transplant), liver alone or liver and kidney transplant recipient from deceased or living donor
- •5) Liver Transplant =>12 weeks prior to screening
- •6) Maintained on TDF alone or in combination with other approved antivirals for HBV
- •prophylaxis or treatment
- •7) Have been on approved HBV OAV treatment for at least 12 weeks post-transplant prior to screening, with HBV DNA < LLOQ at screening
- •8) Screening renal function < 90 ml/min/1.73m^2
- •9) Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
- •10) Women considered of child bearing potential must have a negative serum
- •pregnancy test at Screening and a negative urine test at Baseline before dosing
- •11) Must be willing and able to comply with all study requirements
排除标准
- •1) Multi-organ transplant that includes heart or lung recipient (subjects who have their liver transplant as part of a liver-kidney dual transplant are eligible to enroll)
- •2) Subjects with history of de novo or recurrent hepatocellular carcinoma (HCC) post-transplant and at screening
- •3) Histological evidence of unresolved transplant rejection
- •4) Current, uncontrolled ascites, variceal hemorrhage, hepatic encephalopathy, hepatorenal syndrome, hepatopulmonary syndrome, or other signs of decompensated cirrhosis
- •5) Subjects meeting any of the following laboratory parameters at screening:
- •a) ALT > 10× the upper limit of normal (ULN)
- •b) INR > 1.5 × ULN unless the subject is stable on anticoagulant regimen affecting INR
- •c) Albumin < 3.0 g/dL
- •d) Direct bilirubin => 4 × ULN
- •e) Platelet count < 50,000/mL
- •6) Co-infection with HIV or HCV
- •7) Recent (within 4 weeks of Screening) episode or infection requiring systemic antibiotics
- •8) Use or planned use of T-cell depleting/masking antibodies, systemic antineoplastic agents, cyclosporine > 300 mg/day, or use of any prohibited medications within 28 days of the Baseline/Day 1 visit
- •9) Malignancy within 5 years prior to screening, with the exception of specific cancers that are cured by surgical resection (e.g., basal cell skin cancer, etc) or hepatocellular carcinoma. Subjects under evaluation for possible malignancy are not eligible
- •10) Significant cardiovascular, pulmonary, or neurological disease
- •11) Use of investigational agents within 3 months of screening, unless allowed by the Sponsor
- •12) Use of any prohibited concomitant medications
- •13) Current alcohol or substance abuse judged by the investigator to potentially interfere with subject compliance
- •14) Known hypersensitivity to study drugs, metabolites or formulation excipients
- •15) Lactating females or those who may wish to become pregnant during the course of the study
研究者
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