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Principal Investigator


Kaohsiung Medical Univeristy Chung-Ho Memorial Hospital (在職)

Division of General Internal Medicine

Digestive System Department

更新時間:2023-09-19

莊萬龍Chuang, Wan-Long
  • Principal Investigator
  • Clinical Trial Experience (year) 24 years 1 個月

篩選

List

158Cases

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

2015-04-01 - 2020-12-31

Phase III

Completed
  • Condition/Disease

  • Test Drug

Participate Sites
20Sites

Terminated19Sites

2019-11-01 - 2028-12-31

Phase III

Completed
  • Condition/Disease

  • Test Drug

Participate Sites
5Sites

Recruiting5Sites

2009-02-01 - 2010-11-01

Phase I/II

Completed
  • Condition/Disease

  • Test Drug

Participate Sites
2Sites

Terminated2Sites

2007-12-01 - 2011-07-31

Phase III

Not yet recruiting
  • Condition/Disease

  • Test Drug

Participate Sites
2Sites

Terminated2Sites

2007-10-01 - 2010-12-31

Phase III

Completed
  • Condition/Disease

  • Test Drug

Participate Sites
2Sites

Terminated2Sites

2022-07-01 - 2027-02-26

Phase II

Completed
  • Condition/Disease

  • Test Drug

Participate Sites
8Sites

Not yet recruiting2Sites

Recruiting6Sites

2024-07-15 - 2026-08-31

Phase I

Active
  • Condition/Disease

  • Test Drug

Participate Sites
4Sites

Recruiting4Sites