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Principal Investigator


Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung (在職)

Division of General Internal Medicine

Digestive System Department

Linkou Chang Gung Medical Foundation (在職)

Division of General Internal Medicine

Digestive System Department

更新時間：2023-09-19

簡榮南Chien, Rong-Nan
  • Principal Investigator
  • Clinical Trial Experience (year) 23 years 10 個月

Recruiting Trial

15Cases

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

簡榮南

List

44Cases

2021-06-01 - 2023-06-28

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

2013-12-01 - 2022-12-31

Phase III

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Positive, Chronic Hepatitis B

  • Condition/Disease

    Chronic Hepatitis B

  • Test Drug

    1.Tenofovir Alafenamide (TAF, GS-7340)、 2.Tenofovir Disoproxil Fumarate (TDF, Viread®)

Participate Sites
11Sites

Terminated11Sites

2011-06-01 - 2014-12-31

Phase IV

  • Condition/Disease

  • Test Drug

Participate Sites
14Sites

Terminated14Sites

2013-12-01 - 2022-12-31

Phase III

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Tenofovir Alafenamide (TAF) 25 mg QD versus Tenofovir Disoproxil Fumarate (TDF) 300 mg QD for the Treatment of HBeAg-Negative, Chronic Hepatitis B

  • Condition/Disease

    Chronic Hepatitis B

  • Test Drug

    1.Tenofovir Alafenamide (TAF, GS-7340)、 2.Tenofovir Disoproxil Fumarate (TDF, Viread®)

Participate Sites
8Sites

Terminated8Sites

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

2007-01-01 - 2009-12-01

Phase III

  • Condition/Disease

  • Test Drug

Participate Sites
4Sites

Terminated4Sites

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

2016-07-01 - 2020-01-31

Others

A randomized, double-blind, placebo controlled, 2- part, adaptive design, multicenter 12-week study to assess safety, tolerability and efficacy of LJN452 in patients with non-alcoholic steatohepatitis (NASH)

  • Condition/Disease

    non-alcoholic steatohepatitis (NASH)

  • Test Drug

    LJN452 (tropifexor)

Participate Sites
8Sites

Terminated6Sites

黃志富
Kaohsiung Municipal Gangshan Hospital

未分科

黃怡翔
Taipei Veterans General Hospital

Digestive System Department

2020-08-20 - 2023-12-31

Phase II

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Dose Phase 2 Study to Evaluate the Efficacy and Safety of BMS-986263 in Adults With Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)

  • Condition/Disease

    Compensated Cirrhosis From Nonalcoholic Steatohepatitis (NASH)

  • Test Drug

    BMS-986263

Participate Sites
4Sites

Recruiting4Sites

1 2 3 4 5
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