EUCTR2019-003419-68-NL进行中（未招募）1 期
From fungus to virus, a phase 2a clinical trial investigating the safety and efficacy of terbinafine in chronic hepatitis B patients - HepBTer Trial
Academic Medical Center (AMC)0 个研究点目标入组 26 人开始时间: 2020年3月24日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 26
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
- •1) Age 18 – 60 years
- •2) Proven chronic hepatitis B (CHB) for more than 6 months, based on serology (HBsAg positivity) and at screening a viral load of:
- •i) Group A: HBV DNA =200 IU/mL and <20,000 IU/mL
- •ii) Group B: HBV DNA < 20 IU/mL
- •3) HBeAg-positive and –negative CHB patients
- •4) No current use of any antiviral medication (group A) or currently treated with tenofovir only.
- •5) Normal liver function, assessed by:
- •i) Fibroscan of = 7.0 kiloPascal (kPa)
- •ii) Alanine aminotransferase (ALT) and/or aspirate aminotransferase (AST) at screening = 1.25 x upper limit of normal (ULN)
- •iii) Thrombocytes 150-400 10E9/L
- •iv) Total bilirubin 0-17 µmol/L (elevated levels may be accepted if unconjugated portion is elevated in patients with Gilbert syndrome)
- •v) Albumin within normal value (35 – 50 g/L)
- •vi) Prothrombin Time (PT) within normal value (9,5 - 12.5 sec)
- •vii) Alkaline phosphatase (ALP) and Gamma-glutamyltransferase (GGT) within normal values (40-120 U/L and 0-40 U/L respectively)
- •6) Body mass index (BMI): 17.0-35.0 kg/m2
- •7) Clinical chemistry, hematologic and coagulation tests at screening must be within normal limits or clinically non-significant, as by the investigators assessment.
- •8) At screening, women of child bearing potential must be non-pregnant and non-lactating proven by negative urine or serum pregnancy test at screening.
- •9) Female patients of child-bearing potential (with a fertile male sexual partner) and male patients (if not surgically sterilized) must be willing to use adequate contraception from screening until last study visit.
- •10) At screening, has no recent (<3 months) history of any clinically significant conditions, which, in the opinion of the investigator, would jeopardize the safety of the subject or impact the validity of the study results.
- •11) Voluntary written informed consent must be obtained before any study related interventions (including screening and enrollment) can be conducted.
- •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 26
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Currently active, or a history of liver cirrhosis determined by one or more of the following:
- •i) Liver biopsy;
- •ii) Elastography (e.g. Fibroscan);
- •iii) Combination of usual radiological and biochemical criteria
- •2) Currently active, liver disease other than CHB
- •3) Co-infection with HCV, HDV, HEV and/or HIV
- •4) Acute HAV at screening
- •5) Renal impairment (estimated glomerular filtration rate (eGRF) < 60ml/min)
- •6) Currently active, or a history of: psoriasis or lupus erythematodes
- •7) Use of oral medication that interacts with the liver metabolism enzyme CYP2D6, or which is known to be hepatotoxic or otherwise known to interact with terbinafine (such as rifampicine).
- •8) Usage or plans to receive systemic immunosuppressive or immunomodulating medications (e.g. IFN) during the study or = 4 months prior to the first investigational product administration.
- •9) Clinical diagnosis of substance abuse = 12 months prior to screening with narcotics or cocaine or with alcohol (regular consumption > 14 units/week [men] and > 7 units/week [women])
- •10) Inability to understand the patient information and make an informed decision to participate
研究者
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