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Principal Investigator


Chang Gung Medical Foundation Chang Gung Memorial Hospital, Keelung (在職)

Division of General Internal Medicine

Digestive System Department

Linkou Chang Gung Medical Foundation (在職)

Division of General Internal Medicine

Digestive System Department

更新時間：2023-09-19

簡榮南Chien, Rong-Nan
  • Principal Investigator
  • Clinical Trial Experience (year) 24 years 1 個月

Recruiting Trial

16Cases

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

簡榮南

List

45Cases

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

2017-12-01 - 2020-12-31

Phase III

Not yet recruiting

  • Condition/Disease

  • Test Drug

Participate Sites
2Sites

Terminated2Sites

2015-04-01 - 2020-12-31

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
20Sites

Terminated19Sites

莊萬龍
Kaohsiung Municipal Gangshan Hospital

未分科

2020-07-01 - 2026-09-30

Phase I

Active

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Recruiting4Sites

2018-12-31 - 2026-12-31

Phase III

Not yet recruiting

  • Condition/Disease

  • Test Drug

Participate Sites
2Sites

Recruiting2Sites

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

2022-05-01 - 2023-07-21

Phase II/III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Recruiting8Sites

2023-01-05 - 2026-12-13

Phase III

Completed

  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Recruiting5Sites

2024-11-01 - 2028-06-30

Phase II

Active

  • Condition/Disease

  • Test Drug

Participate Sites
4Sites

Not yet recruiting2Sites

Recruiting2Sites

1 2 3 4 5
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