EUCTR2016-003414-26-IE进行中（未招募）1 期
An open label study of the safety and efficacy of FDC Zepatier (elbasvir and grazoprevir +/- Ribavirin) administered in a community-based setting to HCV infected G1/4 treatment naïve patients on stable opiate substitution therapy with cirrhotic and non-cirrhotic liver disease - The Dublin Zepatier Study
Dr. John Lambert (Mater Misericordiae University Hospital)0 个研究点目标入组 60 人开始时间: 2017年9月6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
- 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
- •1.Subject is =18 years of age.
- •2.Subject must be HCV treatment naive. Subject is willing and able to understand and provide written informed consent prior to participation in this study.
- •3.Documented chronic HCV infection (RNA positive), HCV RNA levels > 10x4 IU/ml.
- •4.Documented HCV genotype 1 and 4.
- •5.Documented HIV and HBV uninfected (HIV Ab negative, HBsAg negative)
- •6.6.A female is eligible to enter and participate in the study if she is of:
- •non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is post-menopausal); or,
- •Child-bearing potential, has a negative pregnancy test (serum ß-HCG) at screen and agrees to two acceptable methods of contraception; a barrier method and one other method of contraception e.g. progesterone-only contraception associated with inhibition of ovulation: oral, injectable, implantable (intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion). Any contraception method must be used consistently and correctly, i.e., in accordance with both the approved product label and the instructions of a physician. Male subjects and their female partners must agree to 7 months post-treatment contraception if taking ribavirin. Female subjects must agree to 4 months post-treatment contraception if taking Ribavirin. Both male (and their female partners) and female subjects must agree to one month post-treatment contraception if taking Zepatier only. A male subject taking Ribavirin must agree to use condoms throughout the period of treatment whether or not their partner is pregnant.
- •7.Stable attender in the site of enrolment (receiving OST at least 3 months before enrolment and were at least 80 % adherent to OST appointments)
- •8.Venous access available for blood monitoring.
- •9.Fibroscan done as per HSE Hepatitis C Advisory Group guidelines.
- •10.Safety bloods done prior to study including a HGB > 9.5g/dL, platelets > 75,000, AST < 10x ULN, albumin levels > 30g/L, ALT < 10 times the ULN.
- •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 60
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1.Child Pugh B or C
- •2.HCV non-G1/G4
- •3.History of decompensated liver disease
- •4.Laboratory exclusions include platelet count <75,000, albumin <30gm/L, ALT >10 times ULN, AST > 10 x ULN, HGB < 9.5g/dL
- •5.Subject is enrolled in one or more investigational drug protocols, which may impact on assessment of HCV treatment with Zepatier (+/_ ribavirin).
- •6.Subject is, in the opinion of the investigator, unable to complete the study dosing period and protocol evaluations and assessments.
- •7.Patients with alcohol and drug use problems that in the view of investigator will compromise adherence to compliance with the study will be excluded.
- •8.Subject is either pregnant or breastfeeding.
- •9.Subject suffers from any serious medical condition (such as pancreatitis, diabetes, congestive heart failure, cardiomyopathy or other cardiac dysfunction), which in the opinion of the Investigator, would compromise the safety of the subject.
- •10.Subject has a pre-existing mental, physical, or substance abuse disorder that, in the opinion of the Investigator, may interfere with the subject’s ability to comply with the dosing schedule and protocol evaluations and assessments.
- •11.Subject has a history of inflammatory bowel disease or intestinal malignancy, intestinal ischemia, malabsorption, or other gastrointestinal dysfunction, which, in the opinion of the Investigator, may interfere with drug absorption or render the subject unable to take oral medication.
- •12.Subject has any acute laboratory abnormality at screening, which, in the opinion of the Investigator, would preclude the subject’s participation in the study of an investigational compound. If subjects are found to have an acute Grade 4 laboratory abnormality at screening, this test may be repeated once within the 45-day screening window. Any verified Grade 4 laboratory abnormality would exclude a subject from study participation.
- •13.Subject has received treatment with radiation therapy or cytotoxic chemotherapeutic agents within 28 days prior to Screening, or has an anticipated need for these agents within the study period.
- •14.Subjects who require treatment with any contraindicated medications, as outlined in the SmPC, within the time period (as specified by MMUH pharmacist) of commencement of investigational product or during treatment.
- •15.Subject has a history of allergy to any of the treatment products or any excipients therein.
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