EUCTR2012-002232-85-CZActive, not recruitingPhase 1
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 with MK-5172 in a Prior Clinical Trial
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- Merck Sharp & Dohme Corp.
- Enrollment
- 350
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- All
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
- •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.
Investigators
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