EUCTR2017-003710-58-IT进行中（未招募）1 期
Study to Investigate the Efficacy of elbasvir/grazoprevir Fixed-Dose Combination for 8 Weeks in G1b Treatment-Na¿ve, HCV-Infected Patients With non-severe Fibrosis, with or without glucose abnormalities ¿ EGG 18¿. - EGG 18
AZIENDA OSPEDALIERA UNIVERSITARIA POLICLINICO PAOLO GIACCONE” DI PALERMO0 个研究点目标入组 75 人开始时间: 2021年6月8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
- 75
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
- •Willing and able to provide written informed consent
- •Male or female, age = 18 years
- •Chronic HCV infection (= 6 months) documented by prior medical history or liver biopsy, only genotype 1b virus. (Positive for anti HCV antibody, HCV RNA, or an HCV genotype)
- •Treatment-naïve with no prior exposure to any IFN, RBV, or approved or experimental HCV-specific DAA
- •Non severe fibrosis (F= 2) according to Metavir score if a biopsy was performed or elasticity measured by Fibroscan® lower than 9.5 kPa or Fibrotest® lower than 0.59 or Fibrometer® lower than 0.63 if Fibroscan® cannot be performed.
- •Patients who are HBV core antibody positive. These patients should be monitored for hepatitis flare or HBV reactivation during HCV treatment and post treatment follow-up. Appropriate patient management for HBV infection as clinically indicated should be initiated as recommended by the European Association for the Study of the Liver. EASL 2017 Clinical Practice Guidelines on the management of hepatitis B virus infection. J Hepatol (2017).
- •Females of childbearing potential must have a negative serum pregnancy test at screening and a negative urine pregnancy test on Day 1 prior to enrollment
- •Male subjects and female subjects of childbearing potential who engage in heterosexual intercourse must agree to use 2 effective method(s) of contraception from at least two weeks prior to Day 1 through 14 days after the last dose of study drugs.
- •A female subject who is not of reproductive potential is eligible without requiring the use of contraception. A female subjects who is not of reproductive potentials is defined as one who has either 1) reached natural menopause (defined as 12 months with no menses without an alternative medical cause), 2) 6 weeks post surgical bilateral oophorectomy with or without hysterectomy, or 3) bilateral tubal ligation.
- •A male subject who is not of reproductive potential is eligible without requiring the use of contraception. A male subject who is not of reproductive potential is defined as: one who has undergone a successful vasectomy. A successful vasectomy is defined as: (1) microscopic documentation of azoospermia, or (2) a vasectomy more than 2 years ago with no resultant pregnancy despite sexual activity post vasectomy.
- •Lactating females must agree to discontinue nursing before starting study drug
- •Subject must be of generally good health, with the exception of chronic HCV infection, and glucose abnormalities as determined by the Investigator
- •Subject must be able to comply with the dosing instructions for study drug administration
- •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 55
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •Is under the age of legal consent, is mentally or legally incapacitated, has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
- •Current or prior history of any of the following:
- •oClinically significant illness (other than HCV) or any other major medical disorder that may interfere with subject treatment, assessment or compliance with the protocol; subjects currently under evaluation for a potentially clinically significant illness (other than HCV) are also excluded
- •oGastrointestinal disorder or post-operative condition that could interfere with the absorption of the study drug
- •oHistory of decompensation (e.g., clinical ascites, encephalopathy, and/or variceal hemorrhage)
- •oSolid organ transplantation (including hematopoietic stem cell transplants) other than kidney, cornea and hair.
- •oSignificant cardiac disease
- •oUnstable psychiatric condition including hospitalization, suicidal attempt, and/or a period of disability as a result of their psychiatric illness within 2 years prior to Screening
- •oMalignancy within the 5 years prior to Screening, with the exception of specific cancers that have been cured by surgical resection (e.g., basal cell skin cancer, etc.). Subjects under evaluation for possible malignancy are not eligible
- •oSignificant drug allergy (e.g., hepatotoxicity)
- •Subject has the following laboratory parameters at Screening:
- •oALT > 10 x the upper limit of normal (ULN)
- •oAST > 10 x ULN
- •oDirect bilirubin > 1.5 x ULN
- •oPlatelets < 75,000/µL
- •oCreatinine clearance < 50 mL/min as calculated by the Cockcroft-Gault equation
- •oHemoglobin < 10 g/dL
- •oAlbumin < 3 g/dL
- •oINR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant regime affecting INR
- •Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson's disease, alfa-1 antitrypsin deficiency, cholangitis)
- •Infection with human immunodeficiency virus (HIV)
- •HBsAg positive patients
- •Clinically-relevant alcohol or drug abuse within 12 months of Screening.
- •Use of any prohibited concomitant medication listed in the specific SmPC section.
- •Known hypersensitivity to the study drug, the metabolites, or formulation excipient
- •Is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another study.
- •(female) is pregnant, lactating, expecting to conceive or donate eggs, or is of childbearing potential and unwilling to commit to two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criteria); or male subject is planning to impregnate or provide sperm donation or has a female sexual partner of childbearing potential and is unwilling to commit to using a two methods of birth control throughout treatment and after the completion of all treatment (see Inclusion Criteria).
- •had a life-threatening SAE during the screening period.
- •is a member or a family member of the investigational study staff or sponsor staff directly involved with this study.
- •has evidence or history of chronic hepatitis not caused by HCV, including but not limited to nonalcoholic steatohepatitis (NASH), drug-induced hepatitis, and autoimmune hepatitis.
- •For subjects diagnosed with diabetes mellitus, documented HbA1c >8.5% (to exclude uncontrolled diabetes)
- •Has any of the following
研究者
相似试验
已完成
1 期
AYURVEDIC MANAGEMENT OF NECK PAIN & STIFFNESS WITH WARM MEDICATED OIL BATH AND MEDICATED PASTE OVER NECK AREA.CTRI/2018/10/016001ational Institute Of Ayurveda30
已完成
不适用
Prospective study about the efficacy of the elbowband for lateral epicondylitisateral epicondylitisJPRN-UMIN000018869Department of Hand Surgery, Nagoya University Graduate School of Medicine100
尚未招募
3 期
Effect of Ayurvedic Eye Treatment in Diabetic RetinopathyCTRI/2022/10/046903ational Institute of Ayurveda Jaipur
进行中（未招募）
1 期
A Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Fenofibrate Coadministration in Patients With Mixed Hyperlipidemia - Ezetimibe/Simvastatin and Fenofibrate Coadministration StudyMixed hyperlipidemiaEUCTR2004-003807-19-ESMerck & Co Inc.600
进行中（未招募）
不适用
A Study to Evaluate the Efficacy and Safety of Ezetimibe/Simvastatin and Fenofibrate Coadministration in Patients With Mixed Hyperlipidemia - Ezetimibe/Simvastatin and Fenofibrate Coadministration StudyMixed hyperlipidemiaMedDRA version: 7.0Level: LLTClassification code 10027762EUCTR2004-003807-19-ATMerck, Sharp & Dohme600