EUCTR2015-003187-37-GB进行中（未招募）1 期
A Phase II, Randomized, Open-Label Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of Elbasvir/Grazoprevir (EBR/GZR) and Sofosbuvir (SOF) with and without Ribavirin (RBV) in Cirrhotic Subjects with Chronic HCV GT3 Infection. - Protocol 083: MK-5172A + Sofosbuvir +/- RBV in Cirrhotic GT3 Subjects.
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
- •1. be =18 years of age on day of signing informed consent.
- •2. HCV RNA (= 10,000 IU/mL in peripheral blood) at the time of screening.
- •3. have documented chronic HCV GT3 (with no evidence of non-typeable or mixed genotype) infection:
- •Positive for anti-HCV antibody, HCV RNA, or HCV genotype 3 at least 6 months before screening, or
- •Positive for anti-HCV antibody or HCV RNA at the time of screening with a liver biopsy consistent with chronic HCV infection (or a liver biopsy performed before enrollment with evidence of CHC disease, such as the presence of fibrosis)
- •4. Be otherwise healthy as determined by the medical history, physical examination, electrocardiogram (ECG), and clinical laboratory measurements performed at the time of screening.
- •5. have liver cirrhosis assessment as follows:
- •Compensated cirrhosis is defined as any one of the following:
- •A liver biopsy performed prior to Day 1 of this study showing cirrhosis (F4)
- •FibroScan® performed within 12 calendar months of Day 1 of this study with a result >12.5 kPa
- •A FibroTest® (FibroSure®) performed during Screening with a score of >0.75 and an aspartate aminotransferase (AST): platelet ratio index (APRI) of >2. APRI formula: AST÷lab upper limit of normal (ULN) for AST x 100÷ (platelet count÷100) (APRI calculation to be provided by the central laboratory.)
- •NOTE: In the absence of a definitive diagnosis of presence or absence of cirrhosis by a FibroTest®, a FibroScan® or liver biopsy is required. Liver biopsy results supersede the results obtained by FibroTest® or FibroScan®.
- •6. has liver imaging within 6 months of Day 1 with no evidence of hepatocellular carcinoma (HCC).
- •NOTE: If liver imaging within 6 months of Day 1 is not available, imaging is required during screening.
- •7. Have a prior treatment history of either:
- •a. HCV treatment-naïve (defined as no prior exposure to any interferon, ribavirin, or other approved or experimental HCV-specific direct-acting antiviral agent)
- •b. Documented prior virologic failure or intolerance to a PR regimen to allow for categorization of prior response:
- •i. PR Null Responder: <2 log10 IU/mL reduction in HCV RNA after at least 12 weeks of a PR regimen OR <1 log10 IU/mL reduction in HCV RNA after 4 weeks and discontinued therapy prior to treatment-week 12.
- •ii. PR Partial Responder: =2 log10 IU/mL reduction in HCV RNA after at least 12 weeks of treatment, but not achieving HCV RNA target not detected at end-of-treatment, with a PR regimen.
- •iii. PR Relapser: HCV RNA target not detected at end-of-treatment with a PR regimen, but HCV RNA quantifiable (= LLOQ) during follow-up.
- •iv. Intolerant to peg-IFN: = 4 weeks of peg-IFN treatment and no more than 80% of treatment duration:
- •1. = 20 weeks for a 24 week treatment regimen
- •2. = 40 weeks for a 48 week treatment duration
- •NOTE: Documentation of prior PR treatment history must include clinic notes or referral letter documenting regimen administered, approximate dates of treatment, approximate date of virologic failure, and a history of laboratory confirmed prior virologic failure or documented intolerance to allow for catego
排除标准
- •1. 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.
- •2. had prior treatment (defined as 1 dose or more) with direct acting antiviral (DAA) therapy.
- •3. has evidence of decompensated liver disease manifested by the presence of or history of ascites, esophageal or gastric variceal bleeding, hepatic encephalopathy, or other signs or symptoms of advanced liver disease.
- •4. is classified as Child-Pugh B or C or has a Child Pugh-Turcotte score (CPT) >6:
- •NOTE: To calculate the Child-Pugh score, refer to the following website: http://www.mdcalc.com/child-pugh-score-for-cirrhosis-mortality.
- •5. is co-infected with hepatitis B virus (e.g., HBsAg positive).
- •6. For subjects with HIV, has a history of opportunistic infection in the preceding 6 months prior to screening. A list of these events may be found in Appendix B of the following document: http://www.cdc.gov/mmwr/preview/mmwrhtml/00018871.htm
- •7. 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 carcinoma in situ; or is under evaluation for hepatocellular carcinoma or other active or suspected malignancy.
- •8. is taking or plans to take any of the prohibited medications listed in the protocol or is taking herbal supplements, including but not limited to St. John’s Wort (Hypericum perforatum) within 2 weeks of Day 1, during treatment, and for at least 2 weeks following the last dose of study drug.
- •9. 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.
- •10. has clinically-relevant drug or alcohol abuse within 12 months of screening.
- •11. is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs from at least 2 weeks prior to Day 1 through at least 6 months after the last dose of study medication or longer if dictated by local regulations, OR is a male subject who is expecting to donate sperm or planning to impregnate female partner(s) from at least 2 weeks prior to Day 1 through at least 6 months after the last dose of study medication or longer if dictated by local regulations.
- •12. is a male whose female partner(s) is/are pregnant (this is a contraindication for ribavirin use)
- •13. has any of the following conditions:
- •a. Organ transplants (including hematopoietic stem cell transplants) other than cornea and hair.
- •b. Poor venous access that precludes routine peripheral blood sampling required for this trial.
- •c. Subject with a history of gastric surgery (e.g., stapling, bypass) or subject with a history of malabsorption disorders (e.g., celiac sprue disease).
- •d. Current or history of any clinically significant cardiac abnormalities/dysfunction, including but not limited to: angina, congestive heart fa
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