EUCTR2015-001483-19-SE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 MK-3682B (MK-5172 + MK-3682 + MK-8408 Fixed Dose Combination (FDC)) in Subjects with Chronic HCV GT1 or GT3 Infection who have failed a Direct Acting Antiviral Regimen - MK-3682B (MK-5172 + MK-3682 + MK-8408 Fixed Dose Combination (FDC)) in HCV GT1 or GT3 DAA Failures
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc0 个研究点目标入组 200 人开始时间: 2015年10月2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
- 入组人数
- 200
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.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 GT1 or HCV GT3 infection (with no evidence of non-typeable or mixed genotype)
- •4.Have documented virologic relapse after treatment with one of the following properly administered direct-acting antiretroviral (DAA) regimens either by approved dosage and duration or by completion of a clinical trial :
- •SOF/LDV ± RBV
- •MK-5172/MK-8742 ± RBV
- •SOF + RBV
- •SOF + DCV ± RBV
- •SOF/LDV ± RBV
- •5.Have liver disease staging assessment for Absence of cirrhosis or Compensated cirrhosis as defined in the protocol
- •6.Can be HIV co-infected as documented as requested by protocol
- •7.HIV co-infected subjects must either not be on antiretroviral therapy(ART); or have well controlled HIV on ART
- •8.meet one of the following categories:
- •a.The subject is a male who is not of reproductive potential, defined as a male who has azoospermia (whether due to having had a vasectomy or due to an underlying medical condition).
- •b.The subject is a female who is not of reproductive potential, defined as a female who either: (1) is postmenopausal (defined as at least 12 months with no menses in women =45 years of age) and have a documented follicle stimulating hormone (FSH) level in the postmenopausal range at pretrial (screening); (2) has had a hysterectomy and/or bilateral oophorectomy, bilateral salpingectomy, or bilateral tubal ligation/occlusion at least 6 weeks prior to screening; OR (3) has a congenital or acquired condition that prevents childbearing.
- •c.The subject is a female or a male who is of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner beginning at least 2 weeks prior to administration of the initial dose of study drug, for 6 months after taking the last dose of study drug if taking a ribavirin-containing regimen (or longer if dictated by local regulations), by complying with one of the following: (1) practice abstinence from heterosexual activity OR (2) use (or have their partner use) two forms of acceptable contraception during heterosexual activity. Acceptable methods of contraception are outlined in the protocol
- •Refer to protocol for a complete list
- •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 180
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1.Under the age of legal consent
- •2.did not complete their prior DAA therapy due to intolerance to the DAA regimen or who discontinued the DAA regimen for reasons other than virologic failure (e.g., non-compliance, lost to follow-up, withdrew consent).
- •NOTE: The trial is limited to those who have documented virologic relapse with a properly administered DAA regimen.
- •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.For cirrhotics, subjects that are Child-Pugh Class B or C or who have a Pugh-Turcotte (CPT) score >6, must be excluded. NOTE: To calculate the Child-Pugh score, refer to the following website: http://www.mdcalc.com/child-pugh-score-for-cirrhosis-mortality.
- •5.is coinfected with hepatitis B virus (e.g. HBsAg positive).
- •6.HIV subjects has a history of opportunistic infection
- •7.History of malignancy within past 5 years; hepatocellular carcinoma under evaluation
- •8.Currently taking prohibited medication
- •9.Is currently participating or has participated in a study with an investigational compound within 30 days prior to study start
- •10.Is a female and is pregnant or breast-feeding, or expecting to conceive or donate eggs from Day 1 through at least 6 months after last dose of study drug, or longer if dictated by local regulations or is a male whose female partner(s) is/are pregnant
- •11.Is a male subject who is expecting to donate sperm or planning to impregnate female partner(s) from Day 1 through at least 6 months after last dose of study drug, or longer if dictated by local regulations.
- •Refer to protocol for a complete list of exclusion criteria
研究者
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