EUCTR2014-003347-35-IT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-5172 and MK-3682 with Either MK-8742 or MK-8408 in Subjects with Chronic HCV GT3 Infection - MK-5172/MK-3682 with MK-8742 or MK-8408 in HCV GT3 Infected Subjects
MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.0 个研究点目标入组 413 人开始时间: 2016年9月12日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 413
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
- •Part A and B:
- •1. be =18 years
- •2. HCV RNA = 10,000 IU/mL
- •3. have documented chronic HCV GT3 infection:
- •?anti-HCV Ab,+ HCV RNA+ , or + to HCV GT 3 at least 6 mo before screening, or
- •?anti-HCV Ab + or HCV RNA + at the time of screening with a liver biopsy consistent with chronic HCV infection
- •4. Be otherwise healthy as determined by medical history, physical examination, ECG, and lab measurements performed at the time of screening.
- •5. have liver disease staging assessment as follows:
- •Absence of cirrhosis is defined as any one of the following (Part A and B):
- •?Liver biopsy performed within 24 mo of Day 1 showing absence of cirrhosis
- •?Fibroscan performed within 12 mo of Day 1 with a result of =12.5 kPa
- •?A Fibrosure® (Fibrotest®) score of =0.48 and APRI of =1 during Screening
- •Compensated cirrhosis is defined as any one of the following (Part B only):
- •?A liver biopsy performed prior to Day 1 showing cirrhosis (F4)
- •?Fibroscan performed within 12 calendar mo of Day 1 with a result >12.5 kPa
- •?A FibroSure® (Fibrotest®) performed during Screening with a score of >0.75 and an APRI of >2.
- •6. Have a prior treatment history of:
- •a. HCV treatment-naïve (Part A and B)
- •b. Prior virologic failure after a Peg-IFN/RBV regimen (Part B only):
- •i. P/R Null Responder
- •ii. P/R Partial Responder
- •iii. P/R Relapser
- •7. meet one of the following categories: a. not of reproductive potential, b. of reproductive potential and agrees to avoid becoming pregnant or impregnating a partner beginning at least 2weeks prior to administration of the initial dose of study drug, and for 90 days after the last dose of study drug by complying with one of the following: (1) practice abstinence† OR (2) use (or have their partner use) two forms of acceptable barrier contraception
- •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 FBR. However, the subject may participate in the main trial without participating in FBR.
- •Part B only:
- •For HIV coinfected subjects these additional criteria must also be met.
- •10. have HIV-1 infection documented by any licensed rapid HIV test or HIV E/CIA test kit at any time prior to Day 1 and confirmed by a licensed Western blot or a second Ab test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 Ag, or plasma HIV-1 RNA viral load.
- •11. meet one of the following criteria:
- •a. not currently and have no plans to initiate ART while in this study.
- •i. subjects not on ART must have CD4+ T-cell count >500 cells/mm3 at screening
- •b. have well controlled HIV on ART, defined as:
- •i. must have achieved virologic suppression (defined as confirmed HIV RNA level below the LLOQ of available assay) on HIV ART at least 8 weeks prior to study entry (Day 1).
- •1. the ART regimen must contain only tenofo
排除标准
- •advanced liver disease
- •3. For cirrhotics (Parts B and C ):
- •a. Child-Pugh B or C, or CPT >5
- •4. HBVcoinfected (HBsAg +).
- •5. HIV coinfected (Part A)
- •6. If HIV+, opportunistic infection < 6 mo prior to screening
- •7. malignancy =5 years prior to signing IC except for treated basal cell or squamous cell skin cancer or in situ cervical cancer or carcinoma in situ; or under evaluation for other active/ suspected malignancy
- •8. cirrhosis and liver imaging < 6 mo of D1 showing evidence of HCC or under evaluation for HCC
- •9. taking/ plans to take prohibited medications listed in the protocol or taking supplements < 2 weeks of D1
- •10. is currently or has participated in an experimental study < 30 Ds of signing IC and is not willing to refrain from participating
- •11. drug or alcohol abuse < 12 mo of screening.
- •12. pregnant or breast-feeding, or expecting to conceive or donate eggs OR expecting to donate sperm from at least 2 weeks prior to D1 until 90 Ds after the last dose of study medication or longer if dictated by local regulations.
- •13. has any of the following conditions: a. Organ transplants (including HSCT) other than
- •cornea and hair. b. Poor venous access that precludes routine peripheral blood sampling c. history of gastric surgery (e.g., stapling, bypass) or malabsorption disorders (e.g., celiac sprue disease). d. Current or history of any clinically significant cardiac abnormalities/dysfunction, including: angina, congestive heart failure, myocardial infarction, pulmonary hypertension, complex congenital heart disease, cardiomyopathy, significant arrhythmia, uncontrolled hypertension, a history of use of antianginal agents for cardiac conditions, prolonged ECG QTc interval (>470 ms for males or >480 ms for females by either the Bazett or Fridericia formula) at the screening visit, personal or family history of Torsade de pointes. e. Chronic pulmonary disease, including: clinical chronic obstructive pulmonary disease, interstitial lung disease, pulmonary fibrosis, sarcoidosis f. CNS trauma requiring intubation, intracranial pressure monitoring, brain meningeal or skull surgery, or resulting in seizure, coma, permanent neurologic deficits, abnormal brain imaging, or CSF leak. Prior brain hemorrhage and/or intracranial aneurysms g. Current or history of seizure disorder unless seizure was >10 years ago, an isolated event, no anti-seizure medications prescribed, and a normal neurological examination is documented < 6 mo of D1 h. History of stroke or transient ischemic attack. i. History of a medical/surgical condition that resulted in hospitalization < the 3 mo prior to enrollmentj. Medical/surgical conditions that may result in a need for hospitalization during the study k.Any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids, TNF antagonists, or other immunosuppressants during trial. l. condition, prestudy laboratory or ECG abnormality or history of any illness, which might confound the results of the study or pose additional risk in administering the study drugs to the subject. m. had a life-threatening SAE during the screening period.n. has evidence of history of chronic hepatitis not caused by HCV
- •14. has exclusionary laboratory values at the screening
研究者
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