EUCTR2014-002808-25-NL进行中（未招募）1 期
Immune phenotyping in chronic hepatitis C patients treated with Sofosbuvir and Daclatasvir combination with or without Ribavirin for 12 or 24 weeks -SODA study
Academic Medical Center Amsterdam0 个研究点开始时间: 2014年11月19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
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.Signed written informed consent
- •-Willingness to sign the written ICF.
- •2.Target population
- •-Previous documentation of positive HCV serology (HCV antibody or HCV RNA) at least 24 weeks prior to enrollment to study, OR Positive HCV serology (HCV antibody or HCV RNA) with a prior remote risk factor (more than 24 weeks prior to Screening) for the acquisition of hepatitis C.
- •-Subjects infected with HCV genotype 1, 3 or 4 on screening laboratory test OR previous availaible documentation of HCV genotype 1,3 or 4 genotype.
- •-Treatment-naïve to or relapsed after IFN-alpha based therapies (including first generation PI failures). Relapse is defined as the recurrence of HCV RNA following the termination of a full course of treatment and after having achieved an undetectable HCV RNA during treatment.
- •3.Age and reproductive status
- •-Age: 18 - 65 years
- •-Subjects must agree to use birth control (condoms) from the time of dosing until 90 days after the follow-up visit; male or female patients who are surgically sterile need not to employ a method of contraception
- •4.Laboratory test findings
- •-Screening hematology, clinical chemistries, coagulation and urinalysis are not clinically significant and the following criteria are met:
- •oPlatelets >50x109/L
- •oTotal white blood cells >3.0x109/L and absolute neutrophil count >1.5x109/L
- •oHemoglobin >6.8 mmol/L for females and >7.4 mmol/L for males
- •oTotal and direct bilirubin < 2 x ULN
- •oALT < 10 x ULN
- •oSerum creatinine within normal limits and estimated creatinine clearance rate as calculated by the Cockcroft-Gault formula >50 mL/min
- •-Negative results on the following screening laboratory tests: HBsAg and HIV antibody OR previous availaible documentation within 1 year before screening of HBsAg and HIV antibody negativity.
- •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 32
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Other known cause of liver disease except for CHC
- •-History or symptoms of decompensated liver disease: Child-Pugh Class B or C, including ascites, hepatic encephalopathy, esophageal variceal bleeding, or other signs of hepatic insufficiency or portal hypertension
- •-History of hepatocellular carcinoma
- •-Concurrent clinically significant medical diagnosis (other than hepatitis C-related conditions) that would potentially interfere with the subjects study compliance or confound study results
- •-History of relevant drug and/or food allergies
研究者
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