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NCT06247735 · ClinicalTrials.gov registry record · Phase 2
Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.
A Phase 2 study of Primary Biliary Cholangitis, sponsored by Kowa Research Institute.
- Active
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
- 20
- Study locations
NCT06247735: Active Phase 2 study of Primary Biliary Cholangitis, sponsored by Kowa Research Institute.
NCT06247735 is a Phase 2 study of Primary Biliary Cholangitis that is active but no longer recruiting, run by Kowa Research Institute. The registered enrollment target is 46 participants, below the 201-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (77% lower). The trial reports 20 study locations across 15 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06247735, a Phase 2 study of Primary Biliary Cholangitis, is active but no longer recruiting, sponsored by Kowa Research Institute.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
- 20
- Study locations
Study Summary
Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
Primary Outcome
Two doses of K-808 compared to placebo after 12 weeks of treatment
Conditions Studied
Interventions
- DRUG Placebo
- DRUG K-808 (Dose A)
- DRUG K-808 (Dose B)
Study Locations (20)
California
- Southern California Research Center - Coronado - Coronado
- Cedars-Sinai Medical Center - Los Angeles
- Velocity Clinical Research - Santa Ana
Florida
- University of Florida Hepatology Research at CTRB - Gainesville
- Florida Research Institute - Lakewood Rch
- University of Miami Leonard M. Miller School of Medicine - Miami
Virginia
- UVA Health - University of Virginia Health System - Charlottesville
- Gastrointestinal and Liver Specialists of Tidewater - Digestive and Liver Disease Specialists - Norfolk
Arizona
- UA Thomas D. Boyer Liver Institute - Tucson
Colorado
- Peak Gastroenterology Associates Colorado Springs - Colorado Springs
Illinois
- Springfield Clinic - Springfield
Maryland
- Mercy Medical Center - Mcauley Plaza - Baltimore
Nebraska
- CommonSpirit Health Research Institute - Omaha
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2024-02-07 |
| Est. Completion | 2026-06 |
| Phase | Phase 2 |
What the registry record for NCT06247735 still lists
NCT06247735 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 201-participant average among 8 other Primary Biliary Cholangitis trials with a reported enrollment target (77% lower).
The record links to 1 condition, with Primary Biliary Cholangitis appearing as the primary indexed condition, and to 3 interventions - of which Placebo is the first listed.
NCT06247735 names 20 study sites across 15 states, led by California, Florida, Virginia.
Frequently Asked Questions
What is clinical trial NCT06247735 about?
NCT06247735 is a clinical study titled "Study to Evaluate the Efficacy and Safety of K-808 (Pemafibrate) in Participants With Primary Biliary Cholangitis (PBC) With Inadequate Response to Ursodeoxycholic Acid (UDCA) and/or Obeticholic Acid (OCA) Treatment.". Study to investigate the efficacy and safety of two doses of K-808 (pemafribate) in subjects with PBC.
What is the current status of trial NCT06247735?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2024-02-07. Estimated completion is 2026-06.
What conditions does trial NCT06247735 study?
This clinical trial studies the following conditions: Primary Biliary Cholangitis.
What interventions are being tested in trial NCT06247735?
The interventions under investigation include: Placebo (DRUG), K-808 (Dose A) (DRUG), K-808 (Dose B) (DRUG).
Who is sponsoring clinical trial NCT06247735?
This trial is sponsored by Kowa Research Institute, which has 44 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06247735 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Primary Biliary Cholangitis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06247735's enrollment target sits among peer trials
46 8th of 8 higher than 1 of 8 other Primary Biliary Cholangitis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Primary Biliary Cholangitis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study to Evaluate Efficacy and Safety of an Investigational Drug Named Volixibat in Patients With Itching Caused by Primary Biliary Cholangitis
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