EUCTR2016-003489-25-BE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
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
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
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 (See exclusion criteria 7).
- •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
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).
- •4) Infection with hepatitis B virus (HBV).
- •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
研究者
相似试验
进行中（未招募）
不适用
A Phase 2, Multicenter, Open-Label Study to Evaluate the Response to and Safety of an 8-Day Course of Phenoptin Treatment in Subjects with Phenylketonuria Who Have Elevated Phenylalanine LevelsTreatment of PhenylketonuriaMedDRA version: 6.1Level: SOCClassification code 10027433EUCTR2004-002071-16-ITBIOMARI
进行中（未招募）
1 期
A trial investigating the safety and efficacy of a drug combination Sofosbuvir/Velpatasvir for Subjects with hepatitis C who are on dialysis for kidney disease.EUCTR2016-003625-42-ESGilead Sciences, Inc.100
进行中（未招募）
1 期
A trial investigating the safety and efficacy of a drug combination Ledipasvir/Sofosbuvir for Subjects with hepatitis C who are on dialysis for kidney disease.Chronic Hepatitis C virus infectionMedDRA version: 20.1Level: PTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.0Level: PTClassification code 10019744Term: Hepatitis CSystem Organ Class: 10021881 - Infections and infestationsEUCTR2016-003489-25-ITGILEAD SCIENCES INCORPORATED95
进行中（未招募）
1 期
A clinical trial to evaluate the efficacy and safety of sofosbuvir/velpatasvir and ribavirin for 12 weeks in people with hepatitis C infection and liver scarring.Chronic hepatitis C virus infectionMedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestationsMedDRA version: 20.1 Level: PT Classification code 10008912 Term: Chronic hepatitis C System Organ Class: 10021881 - Infections and infestationsEUCTR2016-003066-10-FRGilead Sciences International Ltd.32
招募中
2 期
A Phase 2, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of AL001 in Heterozygous Carriers of Granulin or C9orf72 Mutations Causative of Frontotemporal Dementiaa brain disorder which involves dying of nerve cells in the front and sleeping lobesFrontotemporal dementia (FTD)10012272NL-OMON52800Alector Inc11