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临床试验/EUCTR2016-003489-25-IT
EUCTR2016-003489-25-IT进行中（未招募）1 期

A Phase 2, Multicenter, Open-Label Study to Evaluate the Efficacy and Safety of Ledipasvir/Sofosbuvir in Subjects with Genotype 1, 4, 5 and 6 Chronic HCV Infection Who are on Dialysis for End Stage Renal Disease - A trial investigating the safety and efficacy of a drug combination Ledipasvir/Sofosbuvir for Subjec

GILEAD SCIENCES INCORPORATED0 个研究点目标入组 95 人开始时间: 2021年2月15日最近更新:
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试验速览

阶段
1 期
状态
进行中（未招募）
发起方
入组人数
95
研究概览入排标准研究者记录与标识符相似试验

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

  • •Subjects must meet all of the following inclusion criteria to be eligible for participation in this
  • •1) Willing and able to provide written informed consent
  • •2) Male or female age = 18 years
  • •3) Chronic HCV infection (= 6 months) as documented by prior medical history or liver biopsy
  • •4) HCV RNA = LLOQ at screening
  • •5) Genotype 1,4, 5 and 6 HCV as determined at Screening
  • •6) End stage renal disease (ESRD) requiring peritoneal dialysis (PD) or hemodialysis (HD)
  • •7)he most recent HCV treatment must have been completed at least 8
  • •weeks prior to Screening.
  • •8) Subjects must have a determination of treatment experience (treatment naïve vs. treatment experienced). Treatment naïve is defined as having never been exposed to an approved or experimental HCV-specific direct acting antiviral agents or prior treatment of HCV with interferon or ribavirin. All other patients will be considered treatment experienced.
  • •9) Subjects must have appropriate testing for determination of cirrhosis status.
  • •a) Presence of cirrhosis is defined as any one of the following:
  • •i) Fibroscan with a result of > 12.5 kPa
  • •ii) Liver biopsy showing cirrhosis (e.g., Metavir score = 4 or Ishak score = 5)
  • •iii) In the absence of liver biopsy or availability of Fibroscan, FibroTest® score = 0.75 at screening
  • •b) Absence of cirrhosis is defined as any one of the following:
  • •i) Fibroscan with a result of = 12.5 kPa within = 6 months of Baseline/Day 1
  • •ii) Liver biopsy performed within 2 years of Screening showing absence of cirrhosis
  • •iii) In the absence of liver biopsy or availability of Fibroscan, FibroTest® score < 0.75 at screening
  • •10) Liver imaging within 6 months of Baseline/Day 1 is required in cirrhotic subjects only, to exclude HCC
  • •11) Subjects with HIV-1 coinfection may be eligible, provided they satisfy these additional inclusion criteria:
  • •i) Completed at least 3 months of any prior HIV ARV therapy and maintained HIV RNA<50 copies/mL (or 100 cells/mm3 prior to Screening. Subjects with an isolated or
  • •unconfirmed HIV RNA >50 copies/mL (or >LLOQ if the local laboratory assay’s LLOQ
  • •is 50= copies/mL) are not excluded ii) On a stable ARV regimen for = 8 weeks prior to Screening and is expected to continue
  • •the current ARV regimen through the end of study.
  • •12) A negative serum pregnancy test is required for female subjects (unless permanently sterile
  • •or greater than two years post-menopausal).
  • •13) Male subjects and female subjects of childbearing potential who engage in heterosexual
  • •intercourse must agree to use protocol specified method(s) of contraception as described in Appendix 4.
  • •14) Lactating females must agree to discontinue nursing before the study drug is administered.
  • •15) Subject must be able to comply with the dosing instructions for study drug administration and able to complete the study schedule of assessments
  • •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 95
  • •F.1.3 Elderly (>=65 years) yes
  • •F.1.3.1 Number of subjects for this age range 5

排除标准

  • •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
  • •1) Current or prior history of any of the following:
  • •a) Clinically-significant illness (other than HCV, HIV and kidney disease or co-morbidities
  • •associated with ESRD except as noted below) 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
  • •or ESRD) are also excluded.
  • •b) Current or prior history of significant cardiac disease including or resulting in:
  • •¿ Hospital admission for significant cardiovascular disease (myocardial infarction,
  • •unstable angina, heart failure, hypertensive emergency) or has had a cardiovascular
  • •procedure (e.g. CABG or PTCA), within 6 months of Screening
  • •¿ Cardiomyopathy with ejection fraction <50%
  • •c) Gastrointestinal disorder or postoperative condition that could interfere with the
  • •absorption of the study drug.
  • •d) Difficulty with blood collection and/or poor venous access for the purposes of
  • •phlebotomy.
  • •e) Clinical hepatic decompensation (i.e., ascites, encephalopathy or variceal hemorrhage).
  • •f) Solid organ transplantation other than failed kidney transplants (current use of =5 mg/day
  • •of prednisone, or equivalent dose of corticosteroid, allowed).
  • •g) Significant pulmonary disease
  • •h) Psychiatric hospitalization, suicide attempt, and/or a period of disability as a result of
  • •their psychiatric illness within the last 2 years.
  • •i) Malignancy within the 5 years prior to screening, with the exception of specific cancers
  • •that have been cured by surgical resection (basal cell skin cancer, etc). Subjects under
  • •evaluation for possible malignancy are not eligible
  • •2) Screening ECG with clinically significant abnormalities
  • •3) Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease,
  • •alfa-1 antitrypsin deficiency, cholangitis).
  • •5) Opportunistic infection (Appendix 5) within 6 months prior to Screening
  • •6) Infection (other than HIV or HCV) requiring parenteral therapy within 30 days prior to
  • •7) Life threatening SAE during the screening period
  • •8) Subjects has the following laboratory parameters at screening:
  • •a) ALT > 10 X the upper limit of normal (ULN)
  • •b) AST > 10 X ULN
  • •c) Direct bilirubin > 1.5 X ULN. For subjects receiving ritonavir boosted atazanavir
  • •regimen, a direct bilirubin > 1.5 x ULN will be allowed if < 25% of the total bilirubin
  • •d) Platelets < 25,000/µL
  • •e) HbA1c > 9%
  • •f) Hemoglobin < 9 g/dL
  • •g) Albumin < 2.8 g/dL
  • •h) INR > 1.5 x ULN unless subject has known hemophilia or is stable on an anticoagulant
  • •regimen affecting INR
  • •i) Hepatitis B surface antigen positive
  • •9) Prior exposure to any HCV NS5A inhibitor.
  • •10) Male with pregnant female partner.
  • •11) Females who may wish to become pregnant and/or plan to undergo egg harvesting during the
  • •course of the study and up to 30 days of the last dose of study drug
  • •12) Males who may wish to donate sperm during the course of the study until at least 30 days
  • •after the last dose of study drug.
  • •13) Clinically-relevant alcohol or drug abuse within 12 months of screening. A positive drug
  • 另有 4 项未显示

研究者

发起方
GILEAD SCIENCES INCORPORATED

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