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Principal Investigator


National Taiwan University Hospital (在職)

Division of Infectious Disease

Division of General Internal Medicine

更新時間：2023-09-19

柯文謙Ko, Wen-Chien
  • Principal Investigator
  • Clinical Trial Experience (year) 23 years 10 個月

Recruiting Trial

3Cases

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

柯文謙

List

17Cases

2016-09-01 - 2021-11-30

Phase III

A Phase III, randomised, double-blind, multicentre, parallel-group, non-inferiority study evaluating the efficacy, safety, and tolerability of dolutegravir plus lamivudine compared to dolutegravir plus tenofovir/emtricitabine in HIV-1-infected Treatment-naïve Adults adults

  • Condition/Disease

    Infection, Human Immunodeficiency Virus HIV Infections

  • Test Drug

    Dolutegravir(DTG),Lamivudine(3TC).Tenofovir(TDF )/emtricitabine(FTC)

Participate Sites
6Sites

Recruiting5Sites

Terminated1Sites

2019-09-11 - 2023-07-06

Phase III

A Phase 3, Randomized, Double-Blind Study to Evaluate the Safety and Efficacy of Fixed Dose Combination of Bictegravir/Emtricitabine/Tenofovir Alafenamide versus Dolutegravir + Emtricitabine/Tenofovir Disoproxil Fumarate in Treatment Naïve, HIV-1 and Hepatitis B Co-Infected Adults

  • Condition/Disease

    HIV-1 and Hepatitis B Co-Infection

  • Test Drug

    Biktarvy

Participate Sites
9Sites

Recruiting6Sites

Terminated3Sites

2015-06-22 - 2021-12-23

Phase III

A Phase III Multicenter, Double-Blind, Randomized, Active Comparator-Controlled Clinical Trial to Evaluate the Safety and Efficacy of MK-1439A Once-Daily Versus ATRIPLA™ Once-Daily in Treatment-Naïve HIV-1 Infected Subjects

  • Condition/Disease

    HIV-1 Infection

  • Test Drug

    MK1439A

Participate Sites
6Sites

Terminated6Sites

2012-02-01 - 2014-12-31

Phase III

  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Terminated8Sites

2014-02-01 - 2015-11-01

Phase III

A Randomized, Double-Blind, Multi-Center Study to Evaluate the Efficacy and Safety of Intravenous to Oral Solithromycin (CEM-101) Compared to Intravenous to Oral Moxifloxacin in the Treatment of Adult Patients with Community-Acquired Bacterial Pneumonia

  • Condition/Disease

    Community-Acquired Bacterial Pneumonia

  • Test Drug

    Solithromycin (CEM-101)

Participate Sites
2Sites

Terminated1Sites

Study ended1Sites

2012-10-01 - 2014-12-31

Phase III

  • Condition/Disease

  • Test Drug

Participate Sites
6Sites

Terminated6Sites

2009-07-01 - 2013-08-31

Phase III

  • Condition/Disease

  • Test Drug

Participate Sites
12Sites

Terminated12Sites

1 2
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