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Principal Investigator


National Taiwan University Hospital (在職)

Division of Hematology & Oncology

Division of Others-Department of Pathology

Division of General Internal Medicine

更新時間：2023-09-19

尤善琦YU, SHAN-CHI
  • Principal Investigator
  • Clinical Trial Experience (year) 13 years 3 個月

Recruiting Trial

29Cases

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

尤善琦

List

43Cases

2025-03-01 - 2029-03-01

Phase III

Active
A randomized, double-blind, placebo-controlled, multicenter phase 3 clinical trial evaluating the efficacy and safety of Ropeginterferon alfa-2b (P1101) in adult patients with pre-fibrotic/early primary myelofibrosis or marked primary myelofibrosis classified as low- or intermediate-risk 1 according to DIPSS Plus (HOPE-PMF): core trial and its extension trial.

  • Condition/Disease

    Clinically relevant complete hematologic response (CrCHR) at week 80, and symptom assessment indicators at week 80. CrCHR was defined as: 1. Platelet count ≤ 400 x 10^9/L, and 2. White blood cell (WBC) ≤ 10 x 10^9/L, and 3. Peripheral blood: Heme (Hgb) ≥ 10.0 g/dL, and 4. No major thrombotic events, and 5. No progression to secondary acute myeloid leukemia (AML). Symptom assessment indicators were defined as: 6. No worsening of clinical symptoms according to the MFSAF Total Symptom Score (TSS) version 4.0; no worsening of clinical symptoms was defined as: - If the baseline TSS score ≤ 10, then the TSS score remained ≤ 10; or - If the baseline TSS score > 10, then the TSS score did not increase by > 50%.

  • Test Drug

    Ropeginterferon alfa-2b (P1101)

Participate Sites
14Sites

Recruiting14Sites

2021-04-01 - 2027-05-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
17Sites

Not yet recruiting17Sites

2024-06-01 - 2027-07-31

Phase I

Active

  • Condition/Disease

  • Test Drug

Participate Sites
3Sites

Recruiting3Sites

2022-02-01 - 2026-12-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Recruiting5Sites

2021-02-19 - 2025-12-31

Phase I

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Not yet recruiting5Sites

2024-02-01 - 2038-01-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
4Sites

Recruiting4Sites

2024-09-01 - 2028-06-30

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
4Sites

Recruiting4Sites

2017-06-01 - 2026-08-31

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Terminated4Sites

2017-10-01 - 2024-11-07

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
6Sites

Recruiting6Sites

2015-08-01 - 2020-03-31

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
10Sites

Terminated9Sites

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