A Long-Term Follow-up Study to Evaluate Subjects With Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial

• Register: EUCTR
• Last refreshed on: 7 June 2021
• Main ID: EUCTR2012-002232-85-FI
• Date of registration: 29/12/2014
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: A Long-Term Follow-up Study to Evaluate Subjects With Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial
• Scientific title: 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
• Date of first enrolment: 20/01/2015
• Target sample size: 350
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-002232-85
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: no; Randomised: no; Open: no; Single blind: no; Double blind: no; Parallel group: no; Cross over: no; Other: yes; Other trial design description: Long term follow-up study; no therapy is being provided.; If controlled, specify comparator, Other Medicinial Product: no; Placebo: no; Other: no
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): no Therapeutic confirmatory - (Phase III): yes Therapeutic use (Phase IV): no

Countries of recruitment

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

• Name: Global Clinical Trials Operations
• Affiliation: Merck Sharp & Dohme Corp.

• Name: Global Clinical Trials Operations
• Affiliation: Merck Sharp & Dohme Corp.

Key inclusion & exclusion 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:
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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Hepatitis C Virus Infection (HCV)
MedDRA version: 19.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

Therapeutic area: Diseases [C] - Virus Diseases [C02]

Intervention(s)

Pharmaceutical Form:
Current Sponsor code: MK-5172

Primary Outcome(s)

Main Objective: 1. Evaluate the durability of SVR in subjects who remained HCV RNA• All subjects (except subjects PN 052) with HCV RNA2. Evaluate the presence of antiviral resistance, NS3/4A, NS5A and/or NS5B, (as appropriate) and determine if there is a reversion to a wild-type pattern within the 3 years (all protocols except PN 052) or 5 years timeframe for PN 052 of this long-term follow-up study
• Subjects enrolling with quantifiable HCV RNA after having failed therapy will be followed for 3 years or 5 years (PN 052)
3. Evaluate the long-term safety

Secondary Objective: 1. To assess liver function using the MELD and/or Child-Pugh scores for all subjects
2. To assess chronic kidney disease (CKD) status by assessing change in eGFR in patients from parent PN 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 PN 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

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 confirmed HCV RNA > or = LLoQ and was previously or = LLoQ. The percentage of subjects who remain HCV RNA < LLoQ during the course of this study will also be estimated.

In subjects with 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 Outcome(s)

Timepoint(s) of evaluation of this end point: N/A

Secondary end point(s): N/A

Secondary ID(s)

5172-017

2012-002232-85-DE

Source(s) of Monetary Support

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Ethics review

Status: Approved
Approval date: 20/01/2015
Contact: