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: 8 October 2021
• Main ID: EUCTR2012-002232-85-ES
• Date of registration: 25/02/2014
• 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: 07/05/2014
• Target sample size: 3250
• 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): yes Therapeutic confirmatory - (Phase III): no 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, Turkey, United Kingdom, United States

Contacts

• Name: Investigación Clínica
• Affiliation: Merck Sharp & Dohme de España S.A.

• Name: Investigación Clínica
• Affiliation: Merck Sharp & Dohme de España S.A.

Key inclusion & exclusion criteria

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.

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.
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 219
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 13

Exclusion criteria:
1. In the opinion of the investigator, if a subject is mentally or legally incapacitated at entry, the subject may be excluded.


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

Health Condition(s) or Problem(s) studied

Hepatitis C Virus Infection (HCV)
MedDRA version: 16.1 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

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

Intervention(s)

Product Code: MK-5172
Pharmaceutical Form: Tablet
INN or Proposed INN: MK-5172
Current Sponsor code: MK-5172
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 0-

Primary Outcome(s)

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

Primary end point(s): A primary efficacy endpoint is the persistence of SVR which will be evaluated based upon the time to viral relapse. Viral relapse is defined as any subject who has HCV RNA ? 25 IU/mL and was previously <25 IU/mL after end of treatment in previous trial (see Section 2.5). Time to relapse is defined as the time from last dose of 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.

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.

Secondary Outcome(s)

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

Secondary end point(s): N/A

Secondary ID(s)

2012-002232-85-DE

5172-017

Source(s) of Monetary Support

Merck Sharp & Dohme, Corp.

Ethics review

Status: Approved
Approval date: 16/04/2014
Contact: