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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 is a Phase 2 study that has completed, run by Calliditas Therapeutics AB. The registered enrollment target is 111 participants.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03226067
The ClinicalTrials.gov registry entry for NCT03226067 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 111 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Calliditas Therapeutics AB, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo oral capsule is the first listed.
NCT03226067 reports 0 study locations.
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.
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