EUCTR2013-003858-25-SE进行中（未招募）1 期
A Phase II/III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172 and MK-8742 in Subjects with Chronic Hepatitis C Virus Infection and Chronic Kidney Disease
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 220
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
- •Be =18 years of age on day of signing informed consent.
- •Have documented chronic (at least 6 months) HCV GT1 infection (with no evidence of non typable or mixed genotypes) :
- •- Positive for anti-HCV antibody, HCV RNA, or an HCV genotype
- •- HCV RNA (= 10,000 IU/mL in peripheral blood)
- •Have no evidence of cirrhosis based on the following:
- •- Liver biopsy performed within 24 months of Day 1 of this study showing absence of cirrhosis
- •- Fibroscan performed within 12 months of Day 1 of this study with a result of =12.5 kPa
- •- A FibroSure® (Fibrotest®) score of =0.48 and Aspartate Aminotransferase to Platelet Ratio Index (APRI) of =1 during Screening
- •In the absence of a definitive diagnosis of presence or absence of cirrhosis by the above critieria, a liver biopsy is required. Liver biopsy results supersede the results obtained by Fibroscan or FibroSure®.
- •Have an HCV treatment status that is one of the following:
- •Treatment naïve: Naive to all anti-HCV treatment
- •Prior Treatment Relapse: Subjects relapsed after completing a prior course of HCV therapy that included IFN or PEG-IFN + Ribavirin but that did not include any direct acting antivirals.
- •Have Chronic Kidney Disease defined as:
- •Subjects with GFR =29 who are non-dialysis dependent (NDD) or have been on hemodialysis (HD) for at least 3 months (including subjects awaiting kidney transplant and subjects with failed kidney transplants no longer on immunosuppressant therapy).
- •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 220
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Is under the age of legal consent, is mentally or legally incapacitated, has significant emotional problems at the time of pre-study screening visit or expected during the conduct of the study or has a history of a clinically significant psychiatric disorder which, in the opinion of the investigator, would interfere with the study procedures.
- •Evidence of decompensated liver disease manifested by the presence of or history of ascites, gastric or variceal bleeding, hepatic encephalopathy or other signs or symptoms of advanced liver disease. If hepatic cirrhosis is determined by liver biopsy (Stage 4 Metavir or Stage 5, 6 Ishak) participants must be excluded.
- •Is on peritoneal dialysis for management of Kidney disease
- •In the opinion of the investigator the subject has a high likelihood of receiving a renal transplant during the study treatment period (up to 24 weeks from Day 1).
- •Is coinfected with hepatitis B virus (e.g. HBsAg positive) or HIV.
- •Has a history of malignancy =5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer; or has evidence of hepatocellular carcinoma (HCC) or is under evaluation for other active or suspected malignancy.
- •Is currently participating or has participated in a study with an investigational compound within 30 days of signing informed consent and is not willing to refrain from participating in another such study during the course of this study.
- •Has a clinical diagnosis of substance abuse of the following specified drugs within specified timeframes:
- •- alcohol, intravenous drugs, inhalational (not including marijuana), psychotropics, narcotics, cocaine use, prescription or over-the-counter drugs: within 1 year of the screening visit or, if shorter is judged by the investigator to be capable of complying with study procedures, OR
- •NOTE: Subjects receiving opiate agonist substitution therapy are not excluded from the study if, in the opinion of the investigator, the subject is capable of complying with all study procedures
- •- history of marijuana use is deemed excessive by a physician investigator or is interfering with the subject's daily function. If subject's marijuana use is not deemed excessive and does not interfere with daily function, subject must be instructed to discontinue any current use of recreational marijuana prior to entry into trial and throughout the trial period.
- •Female subject who is pregnant or breast-feeding, or expecting to conceive or donate eggs from at least 2 weeks prior to Day 1 and throughout treatment, or longer if dictated by local regulations or male subject who is expecting to donate sperm from at least 2 weeks prior to Day 1 and throughout treatment, or longer if dictated by local regulations.
- •Has any of the following conditions:
- •- Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
- •- Poor venous access in non-dialysis patients that precludes routine peripheral blood sampling required for this trial.
- •- Subject with a history of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease).
- •- Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial.
- •- Has uncontrolled or poorly controlled hypertension including but not limited to hypertensive emergency or hospitalization for hyperten
研究者
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