E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Hepatitis C Virus Infection (HCV) |
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E.1.1.1 | Medical condition in easily understood language |
Hepatitis C Virus Infection |
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E.1.1.2 | Therapeutic area | Diseases [C] - Virus Diseases [C02] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 18.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10019744 |
E.1.2 | Term | Hepatitis C |
E.1.2 | System Organ Class | 10021881 - Infections and infestations |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
1. To evaluate the durability of SVR in subjects who remained HCV RNA <25 IU/mL throughout the follow-up period of the treatment protocol and did not start any new HCV therapy between the end of the previous protocol and entry in this study.
2. To evaluate the presence of antiviral resistance to MK-5172 and determine if there is a reversion to a wild-type pattern within the 3 or 5 year timeframe if subjects were from PN 052 or PN 059) of this long-term follow-up study.
3. To evaluate the long term safety of MK-5172. |
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E.2.2 | Secondary objectives of the trial |
1. To assess liver function using the MELD and/or Child-Pugh scores.
2. To assess chronic kidney disease (CKD) status by assessing change in eGFR in patients from parent Protocol 052.
3. To assess complication of CKD by recording new onset diabetes, cryoglobulinemia, cardiovascular disease, and/or neurologic disorders (such as stroke) in patients from parent Protocol 052.
4. To assess health outcomes by recording the occurrence of variceal bleeding, ascites, spontaneous bacterial peritonitis, encephalopathy, hepatorenal syndrome, hepatocellular carcinoma, liver/kidney transplantation, graft rejection in patient who have undergone liver/kidney transplantation. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. HCV infected subjects who previously participated in an MK-5172 protocol and received at least one dose of MK-5172.
2. Subject must enroll (Visit 1) within one year of the treatment portion of their previous MK-5172 protocol.
If a patient in a treatment protocol received extended follow-up (≥1 year) in the original protocol, they may enroll in this study at the final visit of the previous protocol.
3. Subject must be ≥ 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.
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E.4 | Principal exclusion criteria |
1. In the opinion of the investigator, if a subject is mentally or legally incapacitated at entry, the subject may be excluded. |
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E.5 End points |
E.5.1 | Primary end point(s) |
A primary efficacy endpoint is the durability of long-term SVR which will be evaluated based upon the time to viral relapse. Viral relapse is defined as any subject who has HCV RNA quantifiable and was previously TND at end of treatment and TND or TD(u) during the follow-up period of the previous trial. Relapse would be indicated so long as this was the same genotype of the virus seen in the parent protocol (eg. not a new infection or re-infection (see Section 2.5). Time to relapse is defined as the time from last dose of study therapy taken in previous trial until the date where HCV RNA is ≥25 IU/mL. The percentage of subjects who remain HCV RNA <25 IU/mL during the course of this study will also be evaluated.
In subjects with HCV RNA ≥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. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | Yes |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Long term follow-up study; no therapy is being provided. |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 120 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
Argentina |
Australia |
Austria |
Belgium |
Canada |
Czech Republic |
Denmark |
Estonia |
Finland |
France |
Germany |
Hungary |
Israel |
Italy |
Korea, Republic of |
Lithuania |
Malaysia |
Netherlands |
New Zealand |
Norway |
Poland |
Puerto Rico |
Romania |
Spain |
Sweden |
Taiwan |
Turkey |
United Kingdom |
United States |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 6 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 14 |
E.8.9.2 | In all countries concerned by the trial years | 6 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 14 |