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临床试验/EUCTR2009-013690-18-FR
EUCTR2009-013690-18-FR进行中（未招募）1 期

A Phase 2, Randomized, Open-Label trial of GS-9256 plus GS-9190 alone and in combination with Ribavirin for 28 days in Treatment Naive Subjects with Chronic Genotype 1 Hepatitis C Virus Infection.

Gilead Sciences Inc0 个研究点目标入组 30 人开始时间: 2009年11月26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）
入组人数
30
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 study.
  • •1.Male or female, aged from 18 to 70 years old, inclusive.
  • •2.Willing and able to provide written informed consent.
  • •3.Body mass index (BMI) from 18 to 36 kg/m^2, inclusive.
  • •Note: BMI may be calculated according to either of the following formulae:
  • •BMI = weight in pounds x 703/(height in inches)^2 or weight in kilograms/(height in meters)^2
  • •4. HCV infection limited to genotype 1.
  • •5. Subjects must have baseline plasma HCV RNA = 3 log10 IU/mL at screening, but < 7 log10 IU/mL.
  • •6.Liver biopsy results (or combined results of FibroTest or FibroScan, if considered acceptable by regulators and ethics committess on a country-by-country basis) within the past 2 years prior to screening indicating the absence of cirrhosis. If a liver biopsy or combined FibroTest and FibroScan performed more than 1 year prior to Screening indicates Stage 3 fibrosis, the medical monitor must be consulted prior to enrollment (i.e., consensus must be reached that progression to cirrhosis with hepatic impairment is unlikely to have occurred in the time interval from procedure to enrollment).
  • •7.in addition to being currently positive for HCV RNA and anti-HCV antibody, chronic HCV infection for at least 6 months prior to Baseline (Day 1) documented by:
  • •a) a positive anti-HCV antibody test, positive HCV RNA assay, or HCV genotype test at least 6 months prior to screening, or
  • •b) a liver biopsy with evidence of chronic HCV infection (i.e. there must be some degree of fibrosis, in addition to inflammation, for the biopsy criterion to be accepted as historic data for chronic infection). Combined Fibrotest and FibroScan results may be used in lieu of biopsy, provided there is evidence of fibrosis and combined FibroTest plus FibroScan results are considered acceptable by regulators and ethics committees on a country by country basis, or
  • •c) elevated ALT values (i.e. above the normal range) over a period of greater than 6 months prior to Baseline (Day 1).
  • •On a case-by-case the sponsor will consider permitting enrollment of patients with clear cut clinical histories of chronic infection in circumstances where laboratory documentation cannot be retrieved.
  • •8.Eligible subjects must also be HCV treatment-naïve, defined as no prior exposure to IFNa, RIBA, or experimental HCV therapy, with imminent plans to start standard of care therapy with PEG/RIBA.
  • •9.QTcF interval (QT corrected using Fridericia’s formula) must be =450 msec as determined from screening ECG.
  • •10.Subjects must have the following laboratory parameters at screening: ALT, AST, and GGT = 5 x the upper limit of normal (reference) range (ULN); white blood cell count = 2,500 cells/µL; absolute neutrophil count (ANC) = 1,500 cells/mm3 (unless considered a physiologic variant discussed with and approved by the Gilead medical monitor); potassium and magnesium within normal limits; TSH within normal limits (unless currently being treated for hypothyroidism); hemoglobin (Hb) = 13 g/dL for males and Hb = 12 g/dL for females.
  • •11.Creatinine clearance (CLcr) = 50 mL/min, as calculated by the Cockcroft-Gault equation using lean body weight:
  • •CLer (mL)/min)= (140-Age) x LBW/72 x Scr (x0.85 for female subjects)
  • •Age is calculated in years and Scr is the subject’s measured serum creatinine (in mg/dL).
  • •LBW is the subject’s lean body weight in kilograms, calculated as:
  • •Male: LBW = 50 + 2.3*[(height in c

排除标准

  • •Subjects who meet any of the following exclusion criteria are not to be enrolled in this study.
  • •1.Female of child-bearing potential (defined as a non-menopausal female or a female who is menopausal < 2 years, who has not had a hysterectomy, bilateral oophorectomy or medically documented ovarian failure), pregnant woman, or nursing woman.
  • •[Note: Female subjects who are post-menopausal for < 2 years are required to have a confirmed folloicle-stimulating hormone (FSH) level of = 40 mIU/mL at the screening evaluation).]
  • •2.Male with a female partner planning to become pregnant within 7 months of anticipated last dose of RIBA.
  • •3.Males who are unwilling to use two forms of effective birth control throughout the duration of study treatment and for 7 months after the last dose of RIBA. One method should include a condom with spermicide for males.
  • •4.Evidence of infection or co-infection with a non-genotype 1 HCV strain
  • •5.Poorly controlled diabetes mellitus (hemoglobin A1c > 9 or fasting glucose = 150 mg/dL) .
  • •6.History of hemoglobinopathy (e.g. thalassemia), retinal disese, sarcoidosis
  • •7.History of invasive malignancy diagnosed or treated within 5 years (recent localized treatment of squamous or non-invasive basal cell skin cancers is permitted; cervical carcinoma in situ is allowed if appropriately treated prior to screen); subjects under evaluation for malignancy are not eligible
  • •8.Untreated or significant psychiatric illnesses including severe depression, schizophrenia, psychosis, or a history of a suicide attempt
  • •9.Co-infection with hepatitis B virus (HBV) or human immunodeficiency virus (HIV) or multiple HCV genotypes
  • •10.Chronic use of systemic immunosuppressive agents
  • •11.Presence of autoimmune disorders (e.g. systemic lupus erythematosus, rheumatoid arthritis, psoriasis of greater than mild severity). Subjects with treated hypothyroidism with normal TSH may be enrolled.
  • •12.Severe chronic obstructive pulmonary disease
  • •13.History of significant cardiac disease (including history of myocardial infarction based on ECG and/or clinical history, any history of ventricular tachycardia, congestive heart failure, or dilated cardiomyopathy with left ventricular ejection fraction < 40% ) or a family history of Long QT Syndrome. The following ECG abnormalities at screening are exclusionary: QTcF (QT corrected using Fridericia’s formula) of > 450 msec; QRS > 120 msec (left or right hemiblock is not exclusionary); bradycardia (< 45 beats per minute); second or third degree heart block. A history of clinically significant coronary artery disease without prior myocardial infarction will require consultation with a cardiologist and the medical monitor prior to enrollment
  • •Fridericia’s formula:QTcF=QT/RR0.333
  • •14.Known cirrhosis, Chronic liver disease of a non-HCV etiology (e.g., hemochromatosis, Wilson’s disease, alpha-1 antitrypsin deficiency, cholangitis)
  • •15.History of solid organ transplantation
  • •16.Suspicion of hepatocelluar carcinoma; if a-fetoprotein >50 ng/mL, enrollment is only allowed if results of appropriate diagnostic studies are inconsistent with a diagnosis of hepatocellular tumor
  • •17.Total bilirubin > ULN or known diagnosis of Gilbert’s syndrome
  • •18.Other signs of decompensated liver disease, as indicated by prothrombin time > 1.5 < ULN, platelets < 90,000/mm3 or albumin < 3 g/dL at screening OR current or prior history of clinical hepatic decompensation
  • •19.Subjects with or a history of clinically-significant illness or

研究者

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