Clinical Trials List
2015-03-01 - 2019-06-30
Phase II/III
Terminated7
Study ended1
ICD-10B18.2
Chronic viral hepatitis C
ICD-10B18
Chronic viral hepatitis
ICD-9070.51
Hepatitis C without mention of hepatic coma, acute or unspecified
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
-
Trial Applicant
Merck Sharp & Dohme (I.A.) LLC
-
Sponsor
Merck Sharp & Dohme Corp.
-
Trial scale
Multi-Regional Multi-Center
-
Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Chen-Hua Liu Division of General Internal Medicine
- Chun-Jen Liu Division of General Internal Medicine
- 蘇東弘 Division of General Internal Medicine
- PEI-JER CHEN Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- CHUNG-HSIN CHANG Division of General Internal Medicine
- 葉宏仁 Division of General Internal Medicine
- TENG-YU LEE Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Jee-Fu Huang Digestive System Department
- Ming-Lun Yeh Digestive System Department
- Ming-Lung Yu Digestive System Department
- Chia-Yen Dai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
13 Terminated
Audit
None
Co-Principal Investigator
- Chiu Hung Chiu Digestive System Department
- 邱彥程 Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- 陳威廷 Digestive System Department
- Yi-Cheng Chen Digestive System Department
- Wen-Juei Jeng Digestive System Department
- Chun-Yen Lin Digestive System Department
- Chien-Hao Huang Digestive System Department
The Actual Total Number of Participants Enrolled
13 Terminated
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Hsueh-Chou Lai Digestive System Department
- 陳昇弘 Digestive System Department
- 蘇文邦 Digestive System Department
The Actual Total Number of Participants Enrolled
36 Study ended
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
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.
Safety Endpoints
Safety and signs of disease progression are assessed for all subjects by physical
examination, drug-related serious adverse events, events of clinical interest, any AEs
related to protocol-specified procedures (blood draw), and laboratory tests.
Inclution Criteria
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 except in the circumstance where the previous protocol has a
follow-up period that is ≥1 year.
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.
Exclusion Criteria
entry, the subject may be excluded.
The Estimated Number of Participants
-
Taiwan
141 participants
-
Global
3250 participants
