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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

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

2026-03-15 - 2040-12-31

Phase III

Not yet recruiting

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Not yet recruiting5Sites

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

2025-05-30 - 2027-07-12

Phase III

Active
SYNOVIIIUS: Prospective Interventional Study of Effectiveness of Efanesoctocog Alfa Prophylaxis on Synovial Hypertrophy in Patients with Hemophilia A

  • Condition/Disease

    Hemophilia A

  • Test Drug

    Lyophilized powder for injection Lyophilized powder for injection Lyophilized powder for injection Lyophilized powder for injection Lyophilized powder for injection

Participate Sites
3Sites

Recruiting3Sites

2024-05-01 - 2032-12-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Recruiting5Sites

2015-01-26 - 2025-06-02

Phase II

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
2Sites

Terminated2Sites

2020-04-01 - 2026-09-30

Phase II/III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
2Sites

Recruiting2Sites

2021-04-01 - 2027-01-30

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
2Sites

Recruiting2Sites

2021-11-01 - 2026-02-09

Phase III

Completed
A Randomized, Sham-controlled, Double-blind Study to Evaluate the Efficacy and Safety of Intrathecal OAV101 in Type 2 Spinal Muscular Atrophy (SMA) Patients Who Are ≥ 2 to < 18 Years of Age, Treatment Naive, Sitting, and Never Ambulatory

  • Condition/Disease

    Patients aged 2 to under 18 years with treatment-naïve, late-onset type 2 spinal muscular atrophy (SMA) who are able to sit but have never walked.

  • Test Drug

    OAV101

Participate Sites
2Sites

Not yet recruiting1Sites

Study ended1Sites

1 2 3
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