台灣臨床試驗主持人資料庫|TPIDB

問卷

Log In

繁中 EN

TPIDB

TPIDB Outstanding PI

TPIDB > Search Result > Clinical Trials List

Clinical Trials List

Protocol NumberGS-US-334-0115

2013-08-05 - 2015-11-30

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, Randomized Study to Investigate the Efficacy and Safety of Sofosbuvir plus Ribavirin in Treatment Naïve Subjects with Chronic Genotype 1, 2, 3 and 6 HCV Infection and in Treatment-Experienced Subjects with Chronic Genotype 2 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 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 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 胡琮輝 Digestive System Department

Kaoshiung Chang Gung Memorial Hospital of the C.G.M.F.

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 簡榮男 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 羅錦河 Digestive System Department

E-DA 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 Jia-Horng Kao 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 as follows: • To determine the antiviral efficacy of sofosbuvir (SOF) + ribavirin (RBV) 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+RBV as assessed by review of the accumulated safety data The secondary objectives of this study are as follows: • 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 plasma HCV RNA during treatment and after treatment discontinuation • To evaluate the emergence of viral resistance to SOF during treatment and after treatment discontinuation The exploratory objectives of this study are as follows: • To identify or validate genetic markers that may be predictive of virologic response to therapy and/or tolerability of therapy through genetic discovery research (e.g., pharmacogenomics), in subjects who provide their separate and specific consent • To assess the effect of treatment with SOF + RBV on Health Related Quality of Life (HRQoL)

Test Drug

Sofosbuvir

Active Ingredient

Sofosbuvir

Dosage Form

Tablet

Dosage

400

Endpoints

A

Inclution Criteria

A

Exclusion Criteria

NONE

The Estimated Number of Participants

Taiwan

80 participants
Global

450 participants