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Clinical Trials List

Protocol NumberGS-US-337-0131

2013-08-01 - 2015-10-30

Phase III

Terminated13

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 3b, Multicenter, Open-Label Study to Investigate the Efficacy and Safety of Sofosbuvir/Ledipasvir Fixed-Dose Combination in Treatment-Naïve and Treatment-Experienced Korean and Taiwanese Subjects with Chronic Genotype 1 HCV Infection

Trial Applicant

PAREXEL INTERNATIONAL CO., LTD.
Sponsor

Gilead Sciences, Inc.
Trial scale

Multi-Regional Multi-Center
Update

2025/08/20

Investigators and Locations

Principal Investigator 陳志州 Division of General Internal Medicine

Chi Mei Hospital, Liouying

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 羅錦河 Digestive System Department

E-DA Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Cheng-Yuan Peng Digestive System Department

China Medical University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 王鴻源 Digestive System Department

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 徐友春 Digestive System Department

CHANGHUA CHRISTIAN HOSPITAL

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Rong-Nan Chien Digestive System Department

Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator I-Shyan Sheen Digestive System Department

Linkou Chang Gung Medical Foundation

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 胡琮輝 Digestive System Department

Kaohsiung Veterans General Hosptial

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Jia-Horng Kao Division of General Internal Medicine

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Ting-Tsung Chang Digestive System Department

National Taiwan University Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Chi-Jen Chu Digestive System Department

Taipei Veterans General Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator Wan-Long Chuang Digestive System Department

Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Principal Investigator 王鴻源 Digestive System Department

MacKay Memorial Hospital

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Terminated

Condition/Disease

HCV Infection

Objectives

The primary objectives of this study are: • To determine the antiviral efficacy of treatment with sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) as measured by the proportion of subjects with sustained virologic response (SVR) 12 weeks after discontinuation of therapy (SVR12, defined as HCV RNA < lower limit of quantification [LLOQ] 12 weeks post treatment) • To evaluate the safety and tolerability of SOF/LDV FDC as assessed by review of the accumulated safety data The secondary objectives of this study are: • To determine the proportion of subjects who attain SVR at 4 and 24 weeks after discontinuation of therapy (SVR4 and SVR24) • To evaluate the kinetics of circulating HCV RNA during treatment and after treatment discontinuation • To evaluate the emergence of viral resistance to SOF and LDV during treatment and after treatment discontinuation

Test Drug

Sofosbuvir (SOF)/ledipasvir (LDV) fixed-dose combination (FDC) tablets

Active Ingredient

ledipasvir
Sofosbuvir

Dosage Form

tablet

Dosage

400
90

Endpoints

A

Inclution Criteria

A

Exclusion Criteria

NONE

The Estimated Number of Participants

Taiwan

80 participants
Global

160 participants