EUCTR2015-001483-19-ES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: 2016年1月11日最近更新:
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 relapse, defined as having HCV RNA target not detected at end-oftreatment, but HCV RNA quantifiable (=LLOQ) during follow-up, after treatment with one of the following 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 + PR
- •-SOF + DCV ± RBV
- •-SOF/LDV ± RBV
- •5. be otherwise healthy as determined by the medical history, physical examination, ECG, and clinical laboratory measurements performed at the time of screening
- •6. have liver disease staging assessment as follows:
- •Absence of cirrhosis is defined as any one of 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 = during Screening
- •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 FibroSure® (Fibrotest®) 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.)
- •7. 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, through 6
- •months after taking the last dose of study drug (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.
- •8. understand the study procedures, alternative treatments available, risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
- •9. provide written informed consent for the trial. The subject may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research.
- •Refer to protocol for a complete list
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. has previously received a DAA containing regimen other than the permitted regimens listed in Inclusion Criterion nº4. Examples of exclusionary regimens include, but are not limited to:
- •-SOF + PR or SOF + RBV for GT1
- •-SIM + SOF ± RBV
- •-OBV/PTV/r and DSV ± RBV
- •3. 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.
- •4. 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.
- •5. 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.
- •6. is coinfected with hepatitis B virus (e.g. HBsAg positive).
- •7. 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
- •8. 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 other active or suspected malignancy.
- •9. has cirrhosis and liver imaging within 6 months of Day 1 showing evidence of
- •hepatocellular carcinoma (HCC) or is under evaluation for HCC.
- •NOTE: If liver imaging within 6 months of Day 1 is not available, imaging is
- •required during screening.
- •10. 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) from 2 weeks prior to Day 1 through 2 weeks after the study treatment period.
- •11. 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. (Subjects participating in MK-5172 Protocol 017 may be enrolled in this study, MK- 3682 Protocol 021).
- •12. has clinically-relevant drug or alcohol abuse within 12 months of screening
- •13. is a female and is pregnant or breastfeeding or expecting to conceive or donate eggs from at least 2 weeks prior to Day 1 through at least 6 months after last dose of study drug, 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 two weeks prior to Day 1 through at least 6 months after last dose of study drug, or longer if dictated by local regulations.
- •NOTE: After randomization, those female subjects randomized to a regimen that
- •does not contain ribaviri
研究者
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