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Liver Test Study of Using JKB-122 in Autoimmune Hepatitis (AIH) Patients Who Are Refractory or Intolerant to Current Therapies
NCT02556372 · View on ClinicalTrials.gov ↗
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02556372
The ClinicalTrials.gov registry entry for NCT02556372 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is TaiwanJ Pharmaceuticals Co., which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT02556372 reports 16 study locations spanning 10 distinct geographic areas — top geographies include Texas, California, Washington. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT02556372?
The interventions under investigation include: JKB-122 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT02556372?
This trial is sponsored by TaiwanJ Pharmaceuticals Co., which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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