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A Phase II, Randomized, Double-Blind, Placebo Controlled, Trial of JKB-122 as an Adjunct Therapy to Prednisolone and Azathioprine in the Induction of Remission in Autoimmune Hepatitis (AIH)

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Trial Profile

A Phase II, Randomized, Double-Blind, Placebo Controlled, Trial of JKB-122 as an Adjunct Therapy to Prednisolone and Azathioprine in the Induction of Remission in Autoimmune Hepatitis (AIH)

Status: Not yet recruiting
Phase of Trial: Phase II

Latest Information Update: 07 Feb 2024

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At a glance

  • Drugs JKB 122 (Primary) ; Azathioprine; Prednisolone
  • Indications Autoimmune hepatitis
  • Focus Therapeutic Use
  • Sponsors TaiwanJ Pharmaceuticals

    • Most Recent Events

    • 28 Aug 2020 Number of arms changed from 3 to 4. Experimental arm: JKB-122 Medium dose added. Outcome measures amended. Study phase changed from Phase 2/3 to Phase 2. Planned number of subjects also decreased.
    • 28 Aug 2020 Planned number of patients changed from 210 to 120.
    • 28 Aug 2020 Planned End Date changed from 1 Dec 2023 to 1 Feb 2024.

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