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Principal Investigator


Taipei Veterans General Hospital (在職)

Digestive System Department

Division of General Internal Medicine

National Taiwan University Hospital (在職)

Division of General Internal Medicine

Division of Cardiovascular Diseases

更新時間：2023-09-19

黃惠君
  • Co-Principal Investigator
  • Clinical Trial Experience (year)

Recruiting Trial

10Cases

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

黃惠君

List

28Cases

2025-12-01 - 2032-08-02

Others

Active
AFFIRM: A randomized, double-blind, placebo-controlled trial designed to evaluate the effect of Seladelpar on clinical outcomes in patients with primary biliary cholangitis (PBC) and compensated cirrhosis.

  • Condition/Disease

    1. EFS should be assessed by the time elapsed from the start of treatment to the first occurrence of any of the following adjudicated events at week 156: a. death from any cause b. liver transplantation c. MELD score ≥ 15 d. ascites requiring treatment e. hospitalization for any of the following criterion events: i. esophageal or gastric variceal bleeding ii. hepatic encephalopathy (defined as West Haven score ≥ 2) iii. spontaneous bacterial peritonitis confirmed by diagnostic paracentesis based on WBC count, differential, and/or positive growth in aerobic and/or anaerobic blood cultures. Further details regarding clinical events requiring adjudication should be provided. 2. Assessment of treatment-induced adverse events (TEAEs); biochemical and hematological laboratory evaluation.

  • Test Drug

    Seladelpar

Participate Sites
7Sites

Not yet recruiting7Sites

2017-09-01 - 2019-01-03

Others

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Terminated7Sites

莊萬龍
Kaohsiung Municipal Gangshan Hospital

未分科

2020-11-06 - 2023-12-26

Phase II

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
7Sites

Not yet recruiting2Sites

Recruiting5Sites

2023-02-01 - 2026-12-31

Phase II

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Recruiting5Sites

2023-10-31 - 2027-08-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Not yet recruiting7Sites

2021-01-01 - 2025-06-30

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
7Sites

Recruiting7Sites

2022-06-30 - 2024-10-15

Phase II/III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
4Sites

Terminated4Sites

2023-06-01 - 2026-12-31

Phase II

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
7Sites

Recruiting7Sites

2023-04-13 - 2027-05-05

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
12Sites

Recruiting12Sites

2025-01-01 - 2030-01-31

Phase III

Active

  • Condition/Disease

  • Test Drug

Participate Sites
11Sites

Recruiting11Sites

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