drugset / Trial / NCT02556372

Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies

NCT02556372 ↗

Phase 2 Completed 20 enrolled TaiwanJ Pharmaceuticals Co., Ltd
SequentialOpen-labelTreatment

Summary

This is a Phase 2, pilot study in which JKB-122 is given once daily for 24 weeks in subjects with autoimmune hepatitis (AIH) who have liver enzymes that are 1.25 to 10 times the upper limit of normal (ULN) and who have had a failed response to, incomplete response to, intolerant to, ineligible to, or unwilling to take current immunosuppressant therapies. The dose of JKB-122 will be escalated monthly.

Timeline

Start
2016-04-30
Primary completion
2019-01-21
Completion
2019-01-21

Drugs

EvaluationDrugModalityDoseRoute
Subject JKB-122 Unknown 40 mg Oral

Indications