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NCT03226067 · ClinicalTrials.gov registry record · Phase 2
Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.
A Phase 2 study, sponsored by Calliditas Therapeutics AB.
- Completed
- Registry status
- Phase 2
- Development phase
- 111
- Enrollment target
NCT03226067: Completed Phase 2 study, sponsored by Calliditas Therapeutics AB.
NCT03226067 is a Phase 2 study that has completed, run by Calliditas Therapeutics AB. The registered enrollment target is 111 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03226067, a Phase 2 study, has completed, sponsored by Calliditas Therapeutics AB.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 111 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase (ALP).
Primary Outcome
Percent change in serum GGT from baseline to Week 24 (serum GGT was measured in U/L)
Interventions
- DRUG Placebo oral capsule
- DRUG GKT137831
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 111 participants |
| Start Date | 2017-06-26 |
| Est. Completion | 2019-04-11 |
| Phase | Phase 2 |
What the finished NCT03226067 record still lists
NCT03226067 is an interventional study that assigns participants to a tested intervention. The registered 111 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03226067 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03226067 about?
NCT03226067 is a clinical study titled "Study to Assess Safety & Efficacy of GKT137831 in Patients With Primary Biliary Cholangitis Receiving Ursodiol.". The purpose of this study is to assess the safety and efficacy of GKT13783 in patients with Primary Biliary Cholangitis (PBC) who are taking a stable dose of ursodeoxycholic acid (UDCA) treatment, and have persistently high levels of a liver enzyme called Alkaline Phosphatase (ALP).
What is the current status of trial NCT03226067?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 111 participants. The study started on 2017-06-26. Estimated completion is 2019-04-11.
What interventions are being tested in trial NCT03226067?
The interventions under investigation include: Placebo oral capsule (DRUG), GKT137831 (DRUG).
Who is sponsoring clinical trial NCT03226067?
This trial is sponsored by Calliditas Therapeutics AB, which has 5 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03226067's enrollment target sits among peer trials
111 632nd of 2000 higher than 1,369 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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