EUCTR2014-004145-27-DE进行中（未招募）1 期
A Multicenter, Randomized, Double-blind, Placebo-controlled, Multi-dose Study to Determine the Depth of Hepatitis B Surface Antigen (HBsAg) Reduction Following Intravenous ARC-520 in Combination with Entecavir or Tenofovir in Patients with HBeAg Negative, Chronic Hepatits B Virus (HBV) Infection
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 60
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
- •To be eligible for randomization, the following criteria must be met:
- •1. Male or female, 18 to 75 years of age, inclusive, at the time of informed consent.
- •2. Able to provide written informed consent prior to the performance of any study specific procedures.
- •3. Body mass index (BMI) between 17.5 and 30.0 kg/m2, inclusive. BMI = weight (kg)/(height [m])2
- •4. Have no abnormalities at screening or pre-dose 12-lead ECG assessment (measured after the patient is supine for at least 3 minutes) that, in the opinion of the principal investigator, may compromise patient’s safety in this study.
- •5. Willing and able to comply with all study assessments and adhere to the protocol schedule.
- •6. Have suitable venous access for blood sampling.
- •7. Have no new abnormal finding of clinical relevance at the screening evaluation.
- •8. Have a diagnosis of HBeAg negative, immune active, chronic HBV infection (HBsAg (+) for > 6 months) and all of the following:
- •a. History of being HBsAg positive at 2 time points > 6 months apart, one of which can include at screening
- •b. HBeAg negative at screening
- •c. HBV DNA < 200 IU/mL at screening
- •9. Patients with > 2 months of continuous treatment with daily, oral entecavir (0.5 or 1.0 mg/day) or tenofovir (300 mg/day) and a willingness to continue taking entecavir or tenofovir throughout the study.
- •10. Patients must use 2 effective methods of contraception (double barrier contraception or hormonal contraceptive along with a barrier contraceptive) (both male and female partners) during the study and for 3 months following the last study treatment (ARC-520 or PBO). Males must not donate sperm for at least 3 months post-dose of the last study treatment. Male partners of female patients and female partners of male
- •patients must also use contraception, if they are of childbearing potential. Females of childbearing potential must have a negative urine pregnancy test at screening and predose on Day 1. Females not of childbearing potential must be postmenopausal (defined as cessation of regular menstrual periods for at least 12 months), confirmed
- •by follicle-stimulating hormone (FSH) level > 40 mIU/mL. Contraception that is deemed acceptable in this study includes the following:
- •b. Birth control pills (The Pill)
- •c. Depot or injectable birth control (administered at least 3 months prior to planned study dose)
- •d. Intrauterine device
- •e. Birth Control Patch (eg, Ortho Evra®)
- •f. NuvaRing®
- •g. Surgical sterilization (ie, bilateral tubal ligation, bilateral oophorectomy, or hysterectomy for women or vasectomy for men)
- •Rhythm methods WILL NOT be considered as highly effective methods of contraception, , however abstinence may be allowed based on opinion of treating physician.
- •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 54
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 6
排除标准
- •A potential patient will be excluded from the study if any of the following criteria apply:
- •1. Female patients have a positive pregnancy test or are lactating.
- •2. Acute signs of hepatitis or other severe infection (eg, moderate fever, jaundice, nausea, vomiting, and abdominal pain) evident within 4 weeks of screening and/or at the screening examination.
- •3. Hepatic transaminases (ALT or AST) > 3X upper limits of normal at screening.
- •4. Liver Elastography (i.e. FibroScan®) score> 9 at screening (if FibroScan® is not available, the following tests/criteria are acceptable: FibroTest/Fibrosure score > 0.59 n/a; Accoustic Radiation Force Impulse (ARFI, e.g Siemens Acuson) >1.55 m/s; Shear Wave Elastography (e.g. Aixplorer) >10.0 kPa at screening).
- •5. Patients with antiviral therapy other than entecavir or tenofovir within 3 months of screening or prior treatment with interferon in the last 3 years.
- •6. Use within the last 6 months or an anticipated requirement for anticoagulants, systemically administered corticosteroids, systemically administered immunomodulators, or systemically administered immunosuppressants.
- •7. Use of prescription medication within 14 days prior to administration of study treatment that in the opinion of the PI or the Sponsor would interfere with study conduct. Topical products without systemic absorption, statins (except rosuvastatin), hypertensive medications, OTC & prescription pain medication or hormonal contraceptives (females) are acceptable.
- •8. Has had a depot injection or implant of any drug within 3 months prior to administration of study treatment, with the exception of injectable/implantable birth control.
- •9. Has a known diagnosis of Non-alcoholic steatohepatitis or homozygous or heterozygous familial hypercholesterolemia..
- •10. Patients with any of the following laboratory abnormalities:
- •a. Serum creatinine > 1.5 mg/dL (132.6 µmol/L)
- •b. International normalized ratio (INR) > 1.25 × ULN
- •c. Platelets < 100,000 cells per mL
- •11. Has any history of poorly controlled autoimmune disease especially autoimmune hepatitis.
- •12. Has human immunodeficiency virus (HIV) infection, as shown by the presence of anti-HIV antibody (sero-positive).
- •13. Is sero-positive for HCV, and/or a history of delta virus hepatitis.
- •14. Has hypertension defined as blood pressure > 150/100 mmHg at screening confirmed by repeat. Patients with well-controlled blood pressure on hypertensive medication for > 2 months prior to study treatment administration will be allowed.
- •15. Patients with a history of torsades de pointes, ventricular rhythm disturbances (eg, ventricular tachycardia or fibrillation), pathologic sinus bradycardia (heart rate < 50 bpm), 2nd degree or 3rd degree heart block, congenital long QT syndrome, prolonged QT interval due to medications, or new elevation or depression in the part of an ECG immediately following the QRS complex and merging into the T wave (ST segment) or new pathologic inverted T waves, or new pathologic Q waves on ECG. Patients with a history of atrial arrhythmias should be discussed with the sponsor Medical Monitor and CRO Medical Monitor.
- •16. Has a family history of congenital long QT syndrome, Brugada syndrome or unexplained sudden cardiac death.
- •17. Patients with a mean Fridericia corrected interval between the start of the Q wave and the end of the T wave (QTcF) > 450 msec for males and > 470 msec for females, following ECG tracings at screening.
- •18. Has experienced symptomatic heart f
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