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: 13 September 2021
• Main ID: EUCTR2012-002232-85-DE
• Date of registration: 12/09/2012
• 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: 15/01/2013
• 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. HCV infected 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 = 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 retreated in a Merck-sponsored protocol.


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

Health Condition(s) or Problem(s) studied

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

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

Intervention(s)

Pharmaceutical Form:
Current Sponsor code: MK-5172

Primary Outcome(s)

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 =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.

Main Objective: To evaluate the persistence of SVR in subjects who remained HCV RNA <25 IU/mL throughout the follow-up period of the treatment protocol.

Secondary Objective: 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 year time-frame of this long-term follow-up study.

Timepoint(s) of evaluation of this end point: Yearly reporting

Secondary Outcome(s)

Secondary end point(s): N/A

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

Secondary ID(s)

5172-017

Source(s) of Monetary Support

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

Ethics review

Status: Approved
Approval date: 15/01/2013
Contact: