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Principal Investigator


Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital (在職)

Division of Pediatrics

更新時間：2023-09-19

許琬宜
  • Principal Investigator
  • Clinical Trial Experience (year)

Recruiting Trial

12Cases

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

許琬宜

List

21Cases

2021-08-01 - 2027-10-27

Phase I/II

Active

  • Condition/Disease

  • Test Drug

Participate Sites
3Sites

Recruiting3Sites

2019-03-14 - 2025-06-30

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Terminated5Sites

2021-09-01 - 2023-11-28

Others

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
4Sites

Recruiting4Sites

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

2021-04-01 - 2027-01-30

Phase III

  • Condition/Disease

  • Test Drug

Participate Sites
2Sites

Recruiting2Sites

2020-04-01 - 2026-09-30

Phase II/III

Escalating Dose and Randomized, Controlled Study of Nusinersen (BIIB058) in Participants With Spinal Muscular Atrophy

  • Condition/Disease

    Spinal Muscular Atrophy

  • Test Drug

    Nusinersen

Participate Sites
2Sites

Recruiting2Sites

2015-01-26 - 2025-06-02

Phase II

An Open-Label Study to Assess the Efficacy, Safety, Tolerability, and Pharmacokinetics of Multiple Doses of ISIS 396443 Delivered Intrathecally to Subjects With Genetically Diagnosed and Presymptomatic Spinal Muscular Atrophy.

  • Condition/Disease

    Spinal muscular atrophy

  • Test Drug

    ISIS 396443

Participate Sites
2Sites

Terminated2Sites

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

2024-05-01 - 2039-02-01

Phase IV

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Not yet recruiting5Sites

1 2 3
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