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Principal Investigator


Taichung Veterans General Hospital (在職)

Division of Hematology & Oncology

Division of Pediatrics

更新時間：2023-09-19

施銘洋
  • Co-Principal Investigator
  • Clinical Trial Experience (year)

Recruiting Trial

7Cases

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

施銘洋

List

10Cases

2019-09-01 - 2027-12-31

Phase III

Active
Phase 3, open label, single arm study to evaluate efficacy and safety of FIX gene transfer with PF-06838435 (rAAV-Spark100-hFIX-Padua) in adult male participants with moderately severe to severe hemophilia B (FIX:C≤2%) (BeneGene-2)

  • Condition/Disease

    The study compared the differences between the trial drug before and after infusion, and evaluated the non-inferiority of the annual average bleeding rate (ABR) of total bleeding events (treatment-free and treatment-free) from week 12 to month 15 compared with standard of care (SOC) FIX prophylactic alternative therapy.

  • Test Drug

    injection

Participate Sites
5Sites

Recruiting5Sites

2021-02-15 - 2026-11-26

Phase III

Active
Phase 3, Open-Label, Single-Arm Study to Evaluate the Efficacy and Safety of PF-07055480 (Recombinant AAV2/6 Human Factor VIII Gene Therapy) in Adult Male Participants with Moderately Severe to Severe Hemophilia A (FVIII:C≦1%)

  • Condition/Disease

    Hemophilia A

  • Test Drug

    PF-07055480

Participate Sites
3Sites

Not yet recruiting3Sites

2020-08-15 - 2023-11-23

Phase III

Completed
An Open-Label Study in Adolescent and Adult Severe (Coagulation Factor Activity <1%) Hemophilia A or B Patients With or Without Inhibitors Comparing Standard Treatment to PF-06741086 Prophylaxis

  • Condition/Disease

    (Coagulation Factor Activity <1%) Hemophilia A or B

  • Test Drug

    PF-06741086

Participate Sites
4Sites

Not yet recruiting3Sites

Recruiting1Sites

2020-04-01 - 2026-09-01

Phase I/II

Active
A Phase I/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of NXT007 in Healthy Volunteers and Patients with Hemophilia A

  • Condition/Disease

    Hemophilia A

  • Test Drug

    NXT007

Participate Sites
5Sites

Recruiting5Sites

2019-09-01 - 2027-12-31

Phase III

PHASE 3, OPEN LABEL, SINGLE ARM STUDY TO EVALUATE EFFICACY AND SAFETY OF FIX GENE TRANSFER WITH PF-06838435 (RAAV-SPARK100-HFIX-PADUA) IN ADULT MALE PARTICIPANTS WITH MODERATELY SEVERE TO SEVERE HEMOPHILIA B (FIX:C ≤ 2%) (BENEGENE-2)

  • Condition/Disease

    Hemophilia B

  • Test Drug

    PF-06838435

Participate Sites
5Sites

Recruiting3Sites

Terminated2Sites

2019-06-14 - 2021-11-30

Phase III

ATLAS-PPX: an open-label, multinational, switching study to describe the efficacy and safety of fitusiran prophylaxis in patients with hemophilia A and B previously receiving factor or bypassing agent prophylaxis.

  • Condition/Disease

    Acquired hemophilia

  • Test Drug

    Fitusiran

Participate Sites
6Sites

Recruiting4Sites

Terminated2Sites

2018-03-01 - 2020-05-31

Phase III

ATLAS-A/B: A Phase 3 Study to Evaluate the Efficacy and Safety of Fitusiran in Patients With Hemophilia A or B, Without Inhibitory Antibodies to Factor VIII or IX

  • Condition/Disease

    Hemophilia A or B

  • Test Drug

    Fitusiran (ALN-AT3SC)

Participate Sites
7Sites

Not yet recruiting1Sites

Recruiting6Sites

張家堯
Taipei Medical University Hospital

Division of Pediatrics

2018-01-31 - 2022-12-31

Phase III

ENVISION: A Phase 3 Randomized, Double-blind, Placebo-Controlled Multicenter Study With an Open-label Extension to Evaluate the Efficacy and Safety of Givosiran in Patients With Acute Hepatic Porphyrias

  • Condition/Disease

    Acute Hepatic Porphyrias (AHP)

  • Test Drug

    Givosiran (ALN-AS1)

Participate Sites
3Sites

Terminated3Sites

2019-03-14 - 2025-06-30

Phase III

A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector-Mediated Gene Transfer of Human Factor VIII in Hemophilia A Patients with Residual FVIII Levels <= 1 IU/dL Receiving Prophylactic FVIII Infusions

  • Condition/Disease

    Hemophilia A

  • Test Drug

    BMN 270

Participate Sites
5Sites

Terminated5Sites

2019-03-14 - 2019-09-25

Phase III

A Phase 3 Open-Label, Single-Arm Study To Evaluate The Efficacy and Safety of BMN 270, an Adeno-Associated Virus Vector–Mediated Gene Transfer of Human Factor VIII at a dose of 4E13 vg/kg in Hemophilia A Patients with Residual FVIII Levels <= 1 IU/dL Receiving Prophylactic FVIII Infusions

  • Condition/Disease

    Hemophilia A

  • Test Drug

    BMN 270

Participate Sites
5Sites

Terminated5Sites

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