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Principal Investigator


Taipei Veterans General Hospital (在職)

Division of Hematology & Oncology

Division of General Internal Medicine

更新時間：2023-09-19

簡聖軒Chien, Sheng-Hsuan
  • Principal Investigator
  • Clinical Trial Experience (year) 13 years 3 個月

Recruiting Trial

32Cases

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

簡聖軒

List

42Cases

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

2025-12-19 - 2031-11-30

Phase III

Active
Phase 3 Randomized, Double-blind, Placebo-controlled Studies Assessing Ziftomenib in Combination With Either Standard of Care Nonintensive (Venetoclax+Azacitidine) or Intensive (7+3) Therapy in Patients With Untreated NPM1 Mutated or KMT2A Rearranged Acute Myeloid Leukemia

  • Condition/Disease

    Acute Myeloid Leukemia (AML)

  • Test Drug

    膠囊劑

Participate Sites
5Sites

Not yet recruiting1Sites

Recruiting4Sites

2023-09-01 - 2028-12-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
3Sites

Not yet recruiting2Sites

Recruiting1Sites

2022-05-02 - 2027-03-22

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Not yet recruiting5Sites

2022-04-01 - 2029-10-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Not yet recruiting3Sites

Recruiting1Sites

2021-09-01 - 2025-04-30

Phase I/II

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Not yet recruiting1Sites

Recruiting4Sites

2022-09-01 - 2029-12-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
6Sites

Not yet recruiting1Sites

Recruiting5Sites

2026-05-01 - 2033-12-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
6Sites

Recruiting6Sites

2026-04-01 - 2030-12-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
3Sites

Not yet recruiting3Sites

2019-05-01 - 2027-12-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
6Sites

Recruiting6Sites

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