Hepatitis C Virus Infection (HCV) MedDRA version: 19.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations
Conditions
Interventions
Pharmaceutical Form:
Current Sponsor code: MK-5172
Sponsors
Merck Sharp & Dohme Corp.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Study subjects who previously participated in a HCV treatment protocol that includes MK-5172 in the treatment regimen. 2. Subject must enroll (Visit 1) within three months of the last study visit (e.g. follow-up week 24) of their previous protocol in which they received an MK-5172 containing regimen. Prior to Amendment 03, if a patient in a treatment protocol received extended follow-up (> or = 1 year) in the original protocol, they may enroll in this study at the final visit of the previous protocol. 3. Subject must be > or = 18 years of age and willing to give written informed consent. 4. Subjects who have consented for the trial, may also provide consent for Future Biomedical Research. However, the subject may participate in the main trial without participating in Future Biomedical Research. 5. For Amendment 03: Subjects must have received a MK-5172 containing regimen in a prior trial and have been identified as having failed therapy in that study. 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 300 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: 1. In the opinion of the investigator, if a subject is mentally or legally incapacitated at entry, the subject may be excluded. 2. The subject has received HCV therapy after completion of the protocol defined MK-5172 treatment trial regimen and before or after entry into PN 017. 3. For Amendment 03: Subjects who fail therapy due to re-infection are excluded. 4. For Amendment 03: Subjects who fail therapy and receive retreatment with HCV therapy are excluded, except in the case where they were re-treated in a Merck-sponsored protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 1. Evaluate the durability of SVR in subjects who remained HCV RNA or = LLoQ and was previously or = LLoQ. The percentage of subjects who remain HCV RNA or = 1000 IU/mL at entry or during the study period, HCV sequence analysis will be performed to evaluate the presence of RAVs and the persistence of RAVs over time. ;Timepoint(s) of evaluation of this end point: Yearly reporting | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): N/A;Timepoint(s) of evaluation of this end point: N/A | — |
Countries
Argentina, Australia, Austria, Canada, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Israel, Italy, Lithuania, Netherlands, New Zealand, Poland, Spain, Sweden, United Kingdom, United States
Contacts
Public ContactGlobal Clinical Trials Oerations
Merck Sharp & Dohme Corp.
Outcome results
None listed