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Clinical Trials List

Protocol NumberMK5172-068

2014-06-01 - 2016-05-31

Phase III

Terminated3

ICD-10B17.10

Acute hepatitis C without hepatic coma

ICD-10B19.20

Unspecified viral hepatitis C without hepatic coma

ICD-9070.51

Hepatitis C without mention of hepatic coma, acute or unspecified

A Phase III Randomized Clinical Trial to Study the Efficacy and Safety of the Combination Regimen of MK-5172/MK-8742 in Subjects who have Failed Prior Treatment with Pegylated Interferon and Ribavirin (P/R) with Chronic HCV GT1, GT4, GT5, and GT6 Infection

Trial Applicant

Merck Sharp & Dohme (I.A.) LLC
Sponsor

MERCK SHARP & DOHME (I.A.) LLC. TAIWAN BRANCH (U.S.A.).
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator Jia-Horng Kao Digestive System Department

National Taiwan University Hospital

Co-Principal Investigator

Chun-Jen Liu Digestive System Department
Chen-Hua Liu Digestive System Department
PEI-JER CHEN Digestive System Department
蘇東弘 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Sheng-Shun Yang Digestive System Department

Taichung Veterans General Hospital

Co-Principal Investigator

TENG-YU LEE Digestive System Department
CHUNG-HSIN CHANG Digestive System Department
葉宏仁 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Cheng-Yuan Peng Digestive System Department

China Medical University Hospital

Co-Principal Investigator

蘇文邦 Digestive System Department
Hsueh-Chou Lai Digestive System Department
Hung-Yao Chen Digestive System Department
陳昇弘 Digestive System Department

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

Hepatitis C Virus

Objectives

Primary Objective(s) & Hypothesis(es) (1) Objective: To evaluate the efficacy of MK-5172 in combination with MK-8742 as assessed by the proportion of subjects achieving SVR12 (Sustained Virologic Response 12 weeks after the end of all study therapy), defined as HCV RNA <LLOQ (either TD(u) or TND) 12 weeks after the end of all study therapy. Hypothesis: In at least one of the arms, the proportion of subjects receiving MK5172 in combination with MK-8742 achieving SVR12 will be superior to 58%. (2) Objective: To evaluate the safety and tolerability of MK-5172 in combination with MK-8742.

Test Drug

MK-5172A

Active Ingredient

MK-5172
MK-8742

Dosage Form

table
tablet

Dosage

100
50

Endpoints

In at least one of the arms, the proportion of subjects receiving MK5172 in combination with MK-8742 achieving SVR12 will be superior to 58%.

Inclution Criteria

Inclusion/Exclusion Criteria
All inclusion and exclusion criteria will be reviewed by the investigator or qualified designee
to ensure that the subject qualifies for the trial.

Exclusion Criteria

Inclusion/Exclusion Criteria
All inclusion and exclusion criteria will be reviewed by the investigator or qualified designee
to ensure that the subject qualifies for the trial.

The Estimated Number of Participants

Taiwan

20 participants
Global

400 participants