A Long-Term Follow-up Study looking at the Virologic Response (checking a patient's blood to ensure that there is no detectable virus) and/or Viral Resistance (checking that the virus has not changed in anyway which might mean that treatment is no longer effective) of Subjects With Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial

• Register: EUCTR
• Last refreshed on: 26 March 2024
• Main ID: EUCTR2012-002232-85-GB
• Date of registration: 24/06/2013
• Prospective Registration: Yes
• Primary sponsor: Merck Sharp & Dohme Corp.
• Public title: A Long-Term Follow-up Study looking at the Virologic Response (checking a patient's blood to ensure that there is no detectable virus) and/or Viral Resistance (checking that the virus has not changed in anyway which might mean that treatment is no longer effective) of 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 Risistance Patterns of Subjects with Chronic Hepatitis C Who Have Been Previously Treated with MK-5172 in a Prior Clinical Trial. - A Long Term Follow-up Study of Subjects previously treated with MK5172
• Date of first enrolment: 21/08/2013
• Target sample size: 350
• Recruitment status: Authorised-recruitment may be ongoing or finished
• 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: no 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): 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, Norway, Poland, Spain, Sweden, United Kingdom, United States

Contacts

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

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

Key inclusion & exclusion criteria

Inclusion criteria:
Inclusion criteria apply to both adult and paediatric populations unless otherwise noted.
1. Subjects who previously participated in an HCV treatment study and received GZR in the treatment regimen.
2. Subject must enroll in PN017 (Visit 1) within 3 months of the last study visit (e.g follow-up week 24) of the prior treatment study, in which they received a GZR containing regimen.
3. Subject is male or female 3 years of age or older on day of signing informed consent/assent.
4. Subject or subject’s legally acceptable representative provides written informed
consent (or written informed assent where applicable). Subjects who have consented
for the study may also provide consent/assent for Future Biomedical Research (FBR).
However, the subject may participate in PN017 without consenting/assenting for
FBR.
5. Starting with AM 03: Adult subject must have received at least 1 dose of a GZR containing regimen in the prior treatment study and identified as having failed therapy in that study.
6. Paediatric subject must have received at least 1 dose of a GZR-containing regimen and experienced virologic failure with 1 or more associated treatment-emergent RASs at
FW12 in PN079.
Are the trial subjects under 18? yes
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 298
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 50

Exclusion criteria:
Exclusion criteria apply to both adult and paediatric populations unless otherwise noted.
1. Adult subjects: In the opinion of the investigator, if a subject is mentally or legally incapacitated at entry into PN017.
Paediatric subjects: The subject has significant emotional problems or a clinically
significant psychiatric disorder that may interfere with participant treatment,
assessment, or compliance with the protocol.
2. Subject has received HCV therapy after completion of prior treatment study and before entry into PN017.
3. Starting with AM 03: subjects who failed therapy due to re-infection, defined as:
- an HCV RNA sample with a different genotype than the baseline genotype in the
prior treatment study, or
- an HCV RNA sample determined to be reinfection by phylogenetic analysis with
comparison to the baseline sequence in the prior treatment study.
4. Starting with AM 03: subjects who failed therapy in the prior treatment study and
received retreatment with HCV therapy.


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

Health Condition(s) or Problem(s) studied

Hepatitis C Virus Infection (HCV)
MedDRA version: 20.0 Level: PT Classification code 10019744 Term: Hepatitis C System Organ Class: 10021881 - Infections and infestations

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

Intervention(s)

Product Name: MK-5172
Pharmaceutical Form: Tablet

Primary Outcome(s)

Primary end point(s): For Adult Subjects:
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 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 =1000IU/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.

Main Objective: Adult population:
1. To evaluate the durability of response in subjects who achieved SVR24 in the prior treatment study and at the time of entry into PN017 were HCV ribonucleic acid (RNA) lower limit quantification (LLoQ) (either target not detected [TND] or target detected, unquantifiable [TD(u)]).
2. To evaluate the presence of treatment-emergent antiviral resistance to NS3/4A,NS5A and/or NS5B regions, (as applicable) and determine if there is a reversion to wild-type pattern within the 3-year time frame of this long-term follow-up study (05 5 year time frame for subjects from PN052) in subjects with virologic failure in the prior treatment study and with HCV RNA >/= 1000 IU/mL in Protocol 017.
3. To evaluate long-term safety.

Paediatric Population:
1. To evaluate the persistence of treatment-emergent anti-viral resistance to NS3 and NS5A regions within the 3-year time frame of this long-term follow-up study.

Secondary Objective:

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: n/a

Secondary end point(s): n/a

Secondary ID(s)

MK-5172-017

2012-002232-85-DE

Source(s) of Monetary Support

Merck Sharp and Dohme Corp., a Subsidiary of Merck Sharp and Dohme Inc.

Ethics review

Status: Approved
Approval date: 21/08/2013
Contact:

Results

• Results available: Yes
• Date Posted: 25/03/2022
• Date Completed: 31/03/2021
• URL: https://www.clinicaltrialsregister.eu/ctr-search/trial/2012-002232-85/results