A Long-Term Follow-up Study to Evaluate the Durability of Virologic Response and/or Viral Resistance Patterns of Subjects With Chronic Hepatitis C Who Have Been Previously Treated withMK-5172 in a Prior Clinical Trial

Merck Sharp & Dohme Corp.0 个研究点目标入组 350 人开始时间: 2015年1月16日最近更新: 2021年6月7日

适应症

试验速览

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•Inclusion criteria apply to both adult and pediatric populations unless
•otherwise noted.
•1. Subjects previously participated in a HCV treatment study and received GZR in the treatment regimen.
•2. Subject must enroll in PN017 (Visit 1) within 3 months of the last study visit (e.g. follow-up week [FW] 24) of the prior treatment study in which they received a GZR containing regimen.
•3. Subject is male or female 3 years of age or older on day of signing informed consent/assent.
•4. Subject or subject's legally acceptable representative provides written informed consent (or written informed assent where applicable). Subjects who have consented for the study may also provide consent/assent for Future Biomedical Research (FBR). However, the subject may participate in PN017 without consenting/assenting for FBR.
•5. Starting with AM 03: Adult subject must have received at least 1 dose of a GZR containing regimen in the prior treatment study and identified as having failed therapy in that study.
•6. Pediatric subject must have received at least 1 dose of a GZR containing regimen and experienced virologic failure with 1 or more associated treatment-emergent RASs at FW12 in PN079.
•Are the trial subjects under 18? yes
•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 298
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 50

•Exclusion criteria apply to both the adult and pediatric populations.
•1. Adult subjects: In the opinion of the investigator, subject is mentally or legally incapacitated at entry into PN017. Pediatric subjects: The subject has significant emotional problems or a clinically significant psychiatric disorder that may interfere with
•participant treatment, assessment, or compliance with the protocol.
•2. Subject has received HCV therapy after completion of the prior treatment study and before entry into PN017.
•3. Starting with AM 03: subjects who failed therapy due to re-infection, defined as:
•- an HCV RNA sample with a different genotype than the baseline genotype in the prior treatment study, or -an HCV RNA sample determined to be reinfection by phylogenetic
•analysis with comparison to the baseline sequence in the prior treatment study.
•4. Starting with AM 03: subjects who failed therapy in the prior treatment study and received retreatment with HCV therapy.

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