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Principal Investigator


Linkou Chang Gung Medical Foundation (非在職)

Digestive System Department

Division of General Internal Medicine

更新時間：2023-09-19

沈一嫻Sheen, I-Shyan
  • Principal Investigator
  • Clinical Trial Experience (year) 17 years 10 個月

Recruiting Trial

10Cases

篩選

Developmental Phase

  • Phase I

  • Phase I/II

  • Phase II

  • Phase II/III

  • Phase III

  • Phase IV

  • Others

Trial Status

  • Not yet recruiting

  • Active

  • Completed

Recruitment Status

  • Not yet recruiting

  • Recruiting

  • Completed

  • Terminated

  • Stop recruiting

  • Suspended

  • Study ended

Trial scale

  • Multi-Regional Multi-Center

  • Taiwan Multiple Center

  • Taiwan Single Center

The expected start time interval of the test

-

Trial Applicant

  • Hospital/Foundation

  • Pharmaceutical/Biopharmaceutical company

  • Contract Research Organization

Important Roles

  • Asia Regional PI

  • Taiwan National PI

  • Chairman/Global PI

  • Steering Committee

  • Advisory board

  • None

Audit by Sponsors/CRO

  • Sponsors

  • CRO

  • None

Investigator-initiated trial(IIT)

  • Yes

Filters

沈一嫻

List

59Cases

2009-07-01 - 2012-12-31

Phase II

  • Condition/Disease

  • Test Drug

Participate Sites
3Sites

Terminated3Sites

2020-02-01 - 2021-01-31

Phase I

A Phase 1a/1b Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Single and Multiple Ascending Doses of EDP 514 in Healthy Subjects (Part 1), and Antiviral Activity in Nucleos(t)Ide Reverse Transcriptase Inhibitor (NUC)-Suppressed Patients With Chronic Hepatitis B Virus Infection (Part 2)

  • Condition/Disease

    Chronic hepatitis B virus (CHB) infection

  • Test Drug

    EDP 514

Participate Sites
10Sites

Recruiting3Sites

Terminated7Sites

2018-01-01 - 2020-12-31

Phase II

A Phase 2a, Open-Label, Study Evaluating the Safety and Anti-Viral Activity of ARB-001467 in Non-Cirrhotic, HBeAg-Negative Subjects with Chronic HBV Infection (Genotype A or B) in Combination with PEG-IFN α-2a and Tenofovir Disoproxil Fumarate

  • Condition/Disease

    Chronic HBV Infection (Genotype A or B)

  • Test Drug

    ARB-001467 Injection (2 mg/mL)

Participate Sites
6Sites

Terminated4Sites

彭成元
China Medical University Hospital-Taipei

未分科

林俊彥
Linkou Chang Gung Medical Foundation

Digestive System Department

2019-10-01 - 2023-07-17

Phase III

A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID with and without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared with PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected with Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)ide Therapy (D-LIVR)

  • Condition/Disease

    D-LIVR

  • Test Drug

    Lonafarnib

Participate Sites
6Sites

Recruiting6Sites

2016-08-01 - 2019-04-15

Phase II

A Phase 2, Open-Label, Randomized Two-part, Multiple Dose Study Evaluating the Safety, Pharmacokinetics, and Antiviral Efficacy of SB 9200 in Subjects Infected with Chronic Hepatitis B Virus

  • Condition/Disease

    HBV

  • Test Drug

    SB 9200

Participate Sites
5Sites

Terminated5Sites

2013-08-01 - 2015-10-30

Phase III

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

  • Condition/Disease

    HCV Infection

  • Test Drug

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

Participate Sites
13Sites

Terminated13Sites

2013-08-05 - 2015-11-30

Phase III

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

  • Condition/Disease

    HCV Infection

  • Test Drug

    Sofosbuvir

Participate Sites
13Sites

Terminated13Sites

2017-05-01 - 2025-12-31

Others

AURORA: A Phase 3 Study to Evaluate the Efficacy and Safety of Cenicriviroc for the Treatment of Liver Fibrosis in Adult Subjects With Nonalcoholic Steatohepatitis

  • Condition/Disease

    Nonalcoholic Steatohepatitis

  • Test Drug

    CVC /150mg tablet

Participate Sites
13Sites

Not yet recruiting9Sites

Recruiting1Sites

Terminated1Sites

彭成元
China Medical University Hospital-Taipei

未分科

2009-12-01 - 2012-12-31

Phase II

  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Terminated8Sites

2013-06-01 - 2014-12-31

Phase III

A phase III randomised, double-blind and placebo-controlled study of BI 207127 NA in combination with faldaprevir and ribavirin for chronic genotype 1b hepatitis C virus infection in an extended population of treatment naïve patients that includes those ineligible to receive peginterferon

  • Condition/Disease

    Hepatitis C virus

  • Test Drug

    BI 207127 , Faldaprevir (BI 201335 NA)

Participate Sites
10Sites

Terminated10Sites

1 2 3 4 5 6
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