EUCTR2015-003077-15-DE进行中（未招募）1 期
A Phase 2, Open-Label Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamic Activity of Titrating-Dose Lonafarnib in Combination with Ritonavir in Patients Chronically Infected with Hepatitis Delta Virus (LOWR-4) - LOWR-4
Eiger BioPharmaceuticals0 个研究点目标入组 15 人开始时间: 2015年9月2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
- 15
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
- •A patient may be included in this study if he or she meets all of the following criteria:
- •1. Willing and able to comply with study procedures and provide written informed consent.
- •2. Male or female, 18 to 65 years of age, inclusive.
- •3. Has a body mass index (BMI) of =18 kg/m2 and has a body weight of =45 kg.
- •4. Chronic HDV infection documented by a positive HDV antibody (Ab) test of at least 6 months duration and detectable HDV RNA by qPCR at study entry.
- •5. Liver biopsy demonstrating evidence of chronic hepatitis.
- •If no liver biopsy is available, the patient must be willing to consent to and have no contraindication to liver biopsy. Liver biopsy will be performed during screening.
- •6. ALT <10x ULN
- •7. Electrocardiogram (ECG) demonstrating no acute ischemia or clinically significant abnormality and a QT interval corrected for heart rate (QTc) of < 450 ms using Fridericia correction (ICH Guidance for Industry E14: Clinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential for Non-Antiarrhythmic Drugs).
- •8. Females who meet the following criteria may be eligible to enter the study:
- •a. Of nonchildbearing potential—defined as women who are surgically sterile (have had bilateral tubal ligation, bilateral oophorectomy, or hysterectomy), have medically documented ovarian failure, or are postmenopausal (amenorrheic for more than 2 years, age appropriate, and confirmed by follicle-stimulating hormone [FSH] level indicating a postmenopausal state).
- •b. Of childbearing potential—defined as women who have an intact uterus and ovaries and are within 1 year since the last menstrual period who
- •– Are not pregnant and have negative serum pregnancy test at screening and a negative urine pregnancy test on the Baseline/Day 1 Visit before randomization.
- •– Are not lactating or breastfeeding.
- •– Agree to use two of the following contraceptive methods until at least 90 days after last dose of study drug, of which at least one must be a barrier method:
- •- Hormonal contraceptives for at least 3 months before the start of screening and for at least 90 days after last dose of study drug.
- •- Intrauterine device (IUD) in place for at least 3 months before the start of screening and until at least 90 days after last dose of study drug.
- •- Double-barrier methods (use of condom [male partner] with either diaphragm with spermicide or cervical cap with spermicide) from the start of screening until 90 days after last dose of study drug.
- •- Surgical sterilization of the partner (vasectomy for 1 month before the start of screening and, throughout study and for at least 90 days after last dose of study drug).
- •9. Males with female partners who are of childbearing potential (see above) who meet the following criteria may be eligible to enter the study:
- •a. Are surgically sterile
- •b. Agree to practice two effective forms of birth control from those listed below from the start of screening until at least 90 days after their last dose of study drug, at least one of which must be a barrier method:
- •– Consistently and correctly use a condom
- •– Their partner must agree to use a hormonal contraceptive or a nonhormonal
- •barrier method (IUD or diaphragm with spermicide or cervical cap with
- •spermicide).
- •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 14
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 1
排除标准
- •1. Participation in a trial with or use of any investigational agent within 30 days of
- •start of screening
- •2. Pregnant or lactating/breastfeeding
- •3. Previous use of lonafarnib
- •4. Co-infected with HIV or active infection with HCV
- •5. Positive results for HIV or HCV Ab at screening. Patients with positive HCV Ab at screening are allowed if they have completed a curative antiviral regimen and are documented to be HCV RNA negative (undetectable) at least 3 months before and at screening
- •6. Active jaundice defined by total bilirubin level >2.0 mg/dL and known not to have Gilberts disease
- •7. A CPT score of >6-based on screening lab results
- •8. Decompensated liver disease or cirrhosis as defined by the presence of any of the following on screening lab tests:
- •a. Bilirubin level >2.0 mg/dL
- •b. Albumin level <3.0 g/dL
- •c. Platelet count <90,000 cells/mm3
- •d. International normalized ratio (INR) =1.5
- •9. History of bleeding esophageal varices, ascites, or hepatic encephalopathy
- •10. Patients with any of the following abnormal lab test results at screening:
- •a. White blood cell count <3,000 cells/mm3
- •b. Absolute neutrophil count <1500 cells/mm3
- •c. Hemoglobin <11 g/dL for women and <12 g/dL for men
- •d. Abnormal thyroid-stimulating hormone, T4, or T3 levels; unless the patient is stable on thyroid hormone replacement therapy.
- •11. Significant renal dysfunction, defined as serum creatinine concentration =1.5 times the ULN or an estimated glomerular filtration rate < 80 mL/min at screening, based on the Cockcroft-Gault equation
- •12. Evidence of another form of viral hepatitis (not including HBV or HCV) or another form of liver disease
- •13. Evidence of hepatocellular carcinoma
- •14. Patients with any one of the following:
- •a. An eating disorder or alcohol abuse within the past 2 years
- •b. Excessive alcohol intake defined as follows: >20 g/day for females (1.5 standard
- •alcohol drinks) or >30 g/day for males (2.0 standard alcohol drinks). A standard drink contains 14 g of alcohol: 12 oz of beer, 5 oz of wine, or 1.5 oz of spirits) (1.0 fluid oz [US] = 29.57 mL)
- •15. In the opinion of the Investigator, an alcohol use pattern that will interfere with study conduct
- •16. Drug abuse within the previous 6 months before the screening visit with the exception of medically prescribed cannabinoids and their derivatives
- •17. History or clinical evidence of any of the following:
- •a. Immunologically mediated disease that requires more than
- •intermittent nonsteroidal anti-inflammatory medications for management or that requires use of systemic corticosteroids in prior 6 months
- •b. History of or evidence of retinal disorder or clinically relevant ophthalmic disorder
- •c. Any malignancy within 5 years of the start of screening. Exceptions are superficial dermatologic malignancies
- •d. Significant or unstable cardiac disease
- •e. Chronic pulmonary disease associated with functional impairment
- •f. Pancreatitis
- •g. Severe or uncontrolled psychiatric disease, incl severe depression, history of
- •suicidal ideation, suicidal attempts, or psychosis requiring medication and/or hospitalization
- •18. Solid organ transplantation, incl liver
- •19. Use of alpha interferon, either interferon alfa-2a or interferon alfa-2b, or pegylated interferon alfa-2a or pegylated interferon alfa-2b within 2 months before the start of screening
- •20. Concomitant use of any of the following:
- •a. Medications or foods that are known moderate or strong inducers or
- •inhibitors of CYP3A4 or CYP2C19
- •b. Drugs known to prolong the PR or
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