EUCTR2011-000759-18-DE进行中（未招募）不适用
A Randomized, Active-Controlled Dose-Ranging Estimation Study to Evaluate the Safety, Tolerability, and Efficacy of Different Regimens of MK-5172 When Administered Concomitantly with Peginterferon alfa-2b and Ribavirin in Treatment-Naïve and Prior Treatment Failure to Pegylated Interferon and Ribavirin Patients with Chronic Genotype 1 Hepatitis C Virus Infection - NA
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., USA0 个研究点目标入组 650 人开始时间: 2011年4月27日最近更新:
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 650
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. Patient is =18 years of age on day of signing informed consent.
- •2. Patient has a body weight = 40 kg (88 lbs) and = 125 kg (275 lbs).
- •3. Patient has previously documented CHC GT 1 infection. Patients with other or mixed genotypes are not eligible.
- •4.Patient has HCV RNA value =10,000 IU/mL at screening.
- •5. Absence (no medical history or physical findings) of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs or symptoms of decompensated liver disease.
- •6. For the PTF population, patient has received and tolerated coadministered peg-IFN (alfa-2a- or -2b) and RBV but failed to respond to at least one prior treatment course of at least 12 weeks duration. Patient's HCV treatment history (i.e., type of therapy and duration of therapy) and response to prior treatment (i.e., tolerability and HCV RNA data) should be available such that one of the following definitions are met:
- •Null Response: < 2-log10 IU/mL decline in HCV RNA from the pretreatment baseline to treatment Week 12 (+ 2 weeks).
- •Partial Response: = 2-log10 IU/mL decline in HCV RNA from the pretreatment baseline to treatment Week 12 (+ 2 weeks), but not achieving undetectable HCV RNA at end of treatment with a Peg-IFN and RBV.
- •Breakthrough: Detectable HCV RNA during treatment after initially achieving undetectable HCV RNA.
- •7. For the non-cirrhotic population, patient had a liver biopsy* within 3 years of screening or between screening and Day1 with histology consistent with CHC. For the cirrhotic population, any historic liver biopsy demonstrating cirrhosis will be sufficient regardless of length of time since biopsy:
- •7.1 For the non-cirrhotic population, no evidence of cirrhosis (for example, patients with Metavir scores of F0, F1, F2, and F3 can be included) or hepatocellular carcinoma.
- •7.2. For the compensated cirrhotic population, evidence of cirrhosis (for example, Metavir score of F4) without evidence of hepatocellular carcinoma.
- •7.3 No other etiology for chronic liver disease.
- •7.4 A copy of the local pathology report must be available in the site’s file.
- •7.5 Availability of histology slides suitable for evaluation by the trial central pathologist.
- •8. Female patient who is of childbearing potential or male patient with female sexual partner who is of childbearing potential agrees to use two acceptable methods of birth control from at least 2 weeks prior to Day 1and continue until at least 6 months after last dose of study drug, or longer if dictated by local regulations.
- •9. Patient understands the study procedures, alternative treatments available, and risks involved with the study, and voluntarily agrees to participate by giving written informed consent.
- •10. Patient has had a chest X-ray(unless prohibited by local regulations) within 6 months prior to the screening visit(or between the screening visit and Day 1).
- •11. In the compensated cirrhotic patient population, patient has no evidence of hepatocellular carcinoma as confirmed by ultrasound performed within 4 weeks prior to randomization.
- •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 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Patient 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. Patient is HIV positive or known to be coinfected with hepatitis B virus (HBsAg positive).
- •3. For the PTF patient population, patient received peg-IFN or RBV within 3 months prior to the start of study therapy.
- •4. For the PTF population, patient met the criterion for relapse in prior HCV therapy (defined as detectable HCV RNA after completion of 48 weeks or more of treatment in patients who achieved undetectable HCV RNA and maintained undetectable HCV RNA throughout the remainder of the treatment period).
- •5. For the PTF population, pateint failed a prior regimen that included a first generation protease inibititor (e.g., boceprevir and telaprevir).
- •6. TN patient received prior approved or investigational treatment for hepatitis C; other than herbal remedies,except those with known hepatotoxicity.
- •7. PTF patient received investigational treatment for hepatitis C: other than herbal remedies, except those with known hepatotoxicity.
- •8. Cirrhotic patient has an alfa-fetoprotein level of 100 ng/mL or greater.
- •9. Patient has evidence of hepatocellular carcinoma (HCC) or is under evaluation for HCC.
- •10. Patient is taking or plans to take any of the following medications:
- •10.1 Significant inducers or inhibitors of CYP3A4 2 weeks prior to start of study medications (see Prohibited Medications, Section 3.2.1 for further guidance).
- •10.2 Herbal supplements, including but not limited to St. John’s Wort (Hypericum perforatum) 2 weeks prior to start of study medications (Day 1). Only silymarin (Milk Thistle, Silybum marianum) is permitted during the trial.
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