EUCTR2015-003024-31-IT进行中（未招募）1 期
Anti-viral responses in patients with chronic HCV infection treated with DAA alone or with PEG-IFN based regimens - N.A.
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 30
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.Male or female, age = 18 years
- •2.Evidence of genotype 1 HCV infection (molecular assay)
- •3.Quantifiable plasma HCV RNA
- •4.Documented mild or moderate liver fibrosis (Metavir F0-F3 or Ishak 0-4) assessed by liver biopsy in the past 24 months or by FibroScan™/Elastography (< 12.5 kPa)
- •5.No prior treatment for hepatitis C with any approved or investigational drug
- •6.If women of childbearing potential, negative serum¿¿ human chorionic gonadotropin (¿ hCG) or urine pregnancy test documented at the screening visit and a negative serum or urine pregnancy test before the first dose of study drug to ensure the lack of pregnancy at the time of starting treatment.
- •7.If heterosexually active female of childbearing potential or nonvasectomized male subject with a female partner of childbearing potential, use of 2 effective contraceptives starting with screening and for 7 months after stopping drugs.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1.Infection or coinfection with HCV of another genotype than genotype 1
- •2.Contraindication to the administration of Peg-IFN-alfa or RBV, or medical history or laboratory values that preclude treatment with Peg-IFN-alfa or RBV according to the respective local prescribing information
- •3.Prior exposure to anti-HCV treatment, including any approved or investigational DAA therapy
- •4.Signs or symptoms of HCC. Serum alpha-fetoprotein (AFP) level and ultrasonography should be available at screening for all subjects (both tests should have been done a maximum of 4 months before the screening visit).
- •5.History of decompensated liver disease: history of ascites, hepatic encephalopathy, or bleeding esophageal varices, and/or any of the following screening laboratory results:
- •a.International Normalized Ratio (INR) of =1.5
- •b.Serum albumin <3.3 g/dL
- •c.Serum total bilirubin >1.8 times the upper limit of the laboratory normal range, unless isolated or in subjects with Gilbert’s Syndrome.
- •6.Coinfection with active hepatitis B or HIV
- •7.Any of the following laboratory abnormalities (assessed at local laboratory) as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events (DAIDS):
- •Absolute neutrophil count (ANC) <1,500 cells/mm3
- •Platelet count <90,000 cells/mm3
- •Hemoglobin concentration <12 g/dL in females or <13 g/dL in males
- •Calculated creatinine clearance <50 mL/min
- •Potassium <3.5 mmol/L
- •8.Inadequately controlled thyroid function, as judged by the investigator based on the thyroid stimulating hormone (TSH) results
- •9.Baseline increased risk for anemia (eg, thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be medically problematic
- •10.Severe or uncontrolled cardiac disease during the previous 24 weeks
- •11.Congenital QT prolongation or family history of congenital QT prolongation or sudden death
- •12.History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease
- •13.History of immunologically mediated disease (eg,autoimmune hepatitis, inflammatory bowel disease, idiopathic thrombocytopenic purpura, lupus erythematosus, autoimmune hemolytic anemia, scleroderma, severe psoriasis [defined as affecting >10% of the body, where the palm of one hand equals 1%, or if the hands and feet are affected], rheumatoid arthritis requiring more than intermittent nonsteroidal anti inflammatory medications for management); in case of patients with both autoimmune and viral hepatitis, the sponsor will make the decision about enrollment.
- •14.Clinical evidence of chronic pulmonary disease associated with functional impairment
- •15.History of uncontrolled severe seizure disorders
- •16.Has a history or other evidence of a clinically relevant ophthalmologic disorder due to diabetes mellitus or hypertension or history or other evidence of severe retinopathy (eg, cytomegalovirus, macular degeneration)
- •17.Has a history of major organ transplantation with an existing functional graft with the exception of corneal transplants and skin grafts
- •18.Pregnant or breast-feeding woman
- •19.eGFR <30 ml/min/1.73 mq2 or ESRD
- •20.Use of any medications listed below, within 2 weeks prior to study drug administration: amiodarone, rosuvastatine, proton pump inhibitors at a dosage of omeprazole higher than 20 mg, metotrexate, sulfasalazin
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