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Principal Investigator


Taipei WanFang Hospital (Managed by Taipei Medical Univeristy) (在職)

Division of Infectious Disease

Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Division of Infectious Disease

更新時間：2023-09-19

李文生Lee, Wen-Sen
  • Principal Investigator
  • Clinical Trial Experience (year) 17 years 9 個月

Recruiting Trial

4Cases

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

李文生

List

24Cases

2018-05-01 - 2023-05-17

Phase III

Completed
A PHASE 3 PROSPECTIVE, RANDOMIZED, MULTICENTER, OPEN-LABEL, CENTRAL ASSESSOR-BLINDED, PARALLEL GROUP, COMPARATIVE STUDY TO DETERMINE THE EFFICACY, SAFETY AND TOLERABILITY OF AZTREONAM-AVIBACTAM (ATM-AVI) ±METRONIDAZOLE (MTZ) VERSUS MEROPENEM±COLISTIN (MER±COL) FOR THE TREATMENT OF SERIOUS INFECTIONS DUE TO GRAM NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) - PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS

  • Condition/Disease

    SERIOUS INFECTIONS DUE TO GRAM NEGATIVE BACTERIA, INCLUDING METALLO-Β-LACTAMASE (MBL) - PRODUCING MULTIDRUG RESISTANT PATHOGENS, FOR WHICH THERE ARE LIMITED OR NO TREATMENT OPTIONS

  • Test Drug

    PF-06947387 (Aztreonam –Avibactam)

Participate Sites
7Sites

Not yet recruiting6Sites

Terminated1Sites

2019-08-22 - 2021-06-16

Phase I

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
7Sites

Terminated7Sites

2024-11-15 - 2033-12-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
9Sites

Recruiting9Sites

2025-03-31 - 2028-06-30

Others

Not yet recruiting
A Retrospective, Observational, Post-Marketing Study to Assess the Efficacy and Safety of Intravenous Infusions of Polymyxin B and Colistin Methanesulfonate in Patients with Carbapenem-Resistant Gram-Negative Bacterial Infection

  • Condition/Disease

    Carbapenem-Resistant Gram-Negative Bacterial Infection

  • Test Drug

    injection

Participate Sites
13Sites

Recruiting13Sites

2019-01-01 - 2023-12-31

Phase III

A phase III, randomized, open-label, controlled trial to investigate the efficacy and safety of UB-421 monotherapy as substitution for stable antiretroviral therapy in HIV-1 infected adults

  • Condition/Disease

    HIV

  • Test Drug

    UB-421

Participate Sites
12Sites

Not yet recruiting10Sites

Recruiting1Sites

2007-11-15 - 2008-06-30

Phase II

  • Condition/Disease

  • Test Drug

Participate Sites
24Sites

Terminated23Sites

Study ended1Sites

2016-10-21 - 2018-11-19

Phase II

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus

  • Condition/Disease

    Respiratory Syncytial Virus (RSV)

  • Test Drug

    ALS-008176 (JNJ-64041575)

Participate Sites
6Sites

Terminated6Sites

李岡遠
Taipei Medical University-Shuang Ho Hospital,Ministry of Health and Welfare

Division of Thoracic Medicine

2015-04-01 - 2016-06-30

Phase I/II

A Phase I/II, Prospective, Randomized, Open-Label Study to Evaluate the Safety and Immunogenicity of an Inactivated Cell Culture Derived H7N9 Influenza Vaccine in Healthy Adult Subjects

  • Condition/Disease

    H7N9 Influenza Vaccine

  • Test Drug

    AT-501

Participate Sites
3Sites

Terminated3Sites

2018-10-15 - 2019-11-30

Phase III

A Phase III, Prospective, Randomized, Open-Labeled, Active-Controlled, Multi-Center Study to Evaluate the Safety and Immunogenicity of Quadrivalent Influenza Vaccine, GC FLU, in Adults Aged 20 to 50

  • Condition/Disease

    Influenza

  • Test Drug

    GCFLU Quadrivalent Pre-filled Syringe inj.

Participate Sites
4Sites

Terminated4Sites

李文生
Taipei WanFang Hospital (Managed by Taipei Medical Univeristy)

Division of Infectious Disease

2020-12-26 - 2022-06-30

Phase II

A Phase II, Prospective, Double-blinded, Multi-Centered, Multi-Regional Study to Evaluate the Safety, Tolerability and Immunogenicity of the SARS-CoV-2 vaccine candidate MVC-COV1901

  • Condition/Disease

    COVID-19

  • Test Drug

    MVC-COV1901 vaccine

Participate Sites
11Sites

Not yet recruiting7Sites

Recruiting1Sites

Terminated3Sites

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