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NCT02556372 · ClinicalTrials.gov registry record · Phase 2
Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies
A Phase 2 study of Autoimmune Hepatitis, sponsored by TaiwanJ Pharmaceuticals Co..
- Completed
- Registry status
- Phase 2
- Development phase
- 20
- Enrollment target
- 16
- Study locations
NCT02556372: Completed Phase 2 study of Autoimmune Hepatitis, sponsored by TaiwanJ Pharmaceuticals Co..
NCT02556372 is a Phase 2 study of Autoimmune Hepatitis that has completed, run by TaiwanJ Pharmaceuticals Co.. The registered enrollment target is 20 participants, below the 224-participant average among 5 other Autoimmune Hepatitis trials with a reported enrollment target (91% lower). The trial reports 16 study locations across 10 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02556372, a Phase 2 study of Autoimmune Hepatitis, has completed, sponsored by TaiwanJ Pharmaceuticals Co..
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 20 participants
- Enrollment target
- 16
- Study locations
Study 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.
Primary Outcome
To assess changes in ALT in AIH subjects given daily doses of JKB-122
Conditions Studied
Interventions
- DRUG JKB-122
Study Locations (16)
Texas
- Methodist Dallas Medical Center - Dallas
- Advanced Liver Therapies, Baylor College of Medicine - Houston
- The Texas Liver Institute - San Antonio
- Taxes Liver Institute - San Antonio
California
- Ruane Clinical Research Group, Inc. - Los Angeles
- University of California Davis Medical Center - Ticon 1 - Sacramento
- California Pacific Medical Center - San Francisco
Washington
- Swedish Medical Center - Organ Transplant and Liver Center - Seattle
- University of Washington - Seattle
Florida
- University of Florida Hepatology Research at CTRB - Gainesville
Illinois
- Northwestern University - Chicago
Indiana
- Indiana University School of Medicine - Indianapolis
Louisiana
- Tulane University - New Orleans
Massachusetts
- Massachusetts General Hospital - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2016-04-30 |
| Est. Completion | 2019-01-21 |
| Phase | Phase 2 |
What the finished NCT02556372 record still lists
NCT02556372 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 224-participant average among 5 other Autoimmune Hepatitis trials with a reported enrollment target (91% lower).
The record links to 1 condition, with Autoimmune Hepatitis appearing as the primary indexed condition, and to 1 intervention - of which JKB-122 is the first listed.
NCT02556372 lists 16 locations in 10 states (Texas, California, Washington).
Frequently Asked Questions
What is clinical trial NCT02556372 about?
NCT02556372 is a clinical study titled "Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies". 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, o...
What is the current status of trial NCT02556372?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 20 participants. The study started on 2016-04-30. Estimated completion is 2019-01-21.
What conditions does trial NCT02556372 study?
This clinical trial studies the following conditions: Autoimmune Hepatitis.
What interventions are being tested in trial NCT02556372?
The interventions under investigation include: JKB-122 (DRUG).
Who is sponsoring clinical trial NCT02556372?
This trial is sponsored by TaiwanJ Pharmaceuticals Co., which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02556372 being conducted?
This trial has 16 study locations across California, Florida, Illinois, Indiana, Louisiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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